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תוצאות חיפוש - Omrix Biopharmaceuticals

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משרה
ascdescחברה
ascdescמיקום
בחירה
מיקום : נס ציונה
בחירה
Manager, Global Regulatory Affairs, CMC

Description

Ethicon, Inc., is recruiting for a Manager, Global Regulatory Affairs, CMC for the Ethicon Biosurgery Franchise. The position will focus on biologic products, drug products, and drug-device combination products and may be based at any J&J site. Preferred locations are the J&J sites located at Ness Ziona, Israel or Raritan, New Jersey, United States. Other J&J locations throughout the U.S. and Europe will be considered. Remote work options may be considered on a case-by-case basis and if approved by the Company.

Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.

The Manager, Global Regulatory Affairs, CMC for Ethicon’s Biosurgery business unit will be responsible for leading a team of Regulatory professionals and partnering with R&D, Supply Chain, and other cross-functional team members and leaders to obtain and maintain Ethicon’s biologic, drug, and combination product portfolio globally through project team support, audit support, excellence in submission execution, global health authority interactions, and growing and developing talent.

The products supported by this position are regulated worldwide as biologics, drugs, or high-risk medical device (combination products) which are intended to address a range of surgical challenges related to bleeding and sealing. Primary responsibilities will include:

Key Responsibilities:
• Lead, inspire, motivate, and manage a team of Regulatory CMC professionals to obtain and maintain market access for Chemistry, Manufacturing, and Controls (CMC) related changes to Ethicon Biosurgery biologic, drug, and combination products. (Currently this position is responsible for managing 5 team members, which includes both permanent and contract staff.
• Mentor, coach, train, and develop technical and professional skills of the Regulatory CMC team.
• Maintain up-to-date understanding of global biologic, drug, and combination product regulations and guidance documents and advise Regulatory Affairs team and internal stakeholders on the interpretation and application of health authority expectations.
• Oversee assessment and communication of global CMC changes, strategies, risks, and requirements to internal business partners and leadership teams.
• Clearly and timely communicate compliance issues to Regulatory Management and business leadership that could affect registration or regulatory compliance.
• Active role on project teams to maintain close alignment between supply chain strategy and regulatory compliance and timelines.
• Oversee the strategy development, health authority negotiations, submission content, and post market commitments for U.S., EU, and Israel CMC-related regulatory filings.
• Partner with regional Regulatory leaders on regulatory strategy and submissions to successfully obtain and maintain marketing approvals for all other markets.
• Partner with external manufacturers and strategic external partners to communicate CMC changes, evaluate impact of changes, and ensure joint regulatory responsibilities are fulfilled and compliant.
• Lead Health Authority meetings for key markets and interact with Health Authorities regarding product regulatory filings.
• Evaluate the impact of current and emerging standards and regulations, assess the most effective and efficient strategies for obtaining or maintaining product registrations globally, and communicate changes and impact to cross-functional business partners.
• Demonstrate a deep scientific and technical understanding of products under the scope of responsibility to provide strategic guidance and support for product development and life-cycle management of products.
• Integrate changing, complex, and/or ambiguous information for effective decision-making and clearly communicate challenges and solutions to stakeholders to achieve strategic and/or project goals.
• Collaborate with Quality partners regarding product non-conformance and quality issues by contributing to internal investigation and risk management reviews.
• Manage, oversee, and balance resource allocation across critical projects.
• Influence and collaborate to bring about process and technical improvements within the organization.
• Manage front-room and back-room regulatory activities associated with internal and external audits.
• Ensure that company policies, procedures and practices are compliant with appropriate regulatory requirements.

Requirements

Education:
• Bachelor’s/undergraduate degree is required.
• Advanced degree is a plus.
• Degree in a technical related discipline (e.g. biological, pharmaceutical, or chemical sciences) is preferred.

Experience and Skills:
• A Bachelor's degree and at least 8 years of regulated healthcare industry experience, or an advanced degree and a minimum of 5 years of regulated healthcare industry experience is required.
• Previous experience with biologic or drug Regulatory Affairs is required.
• Previous experience with medical device and/or combination product regulatory affairs is preferred.
• Demonstrated track record representing your function on cross-functional or leadership teams is required.
• Previous experience developing and executing regulatory strategies that align with business deliverables is preferred.
• Previous experience leading, mentoring, coaching, or developing people or teams is required.
• Previous experience interacting with Health Authorities (for example: FDA, EMA, or other Health Authority meetings, negotiations, or audits) is required.

Job Requirements:
• High-level verbal and written communication skills is required.
• Up to 10% travel may be required. (Primary locations for travel may include Israel, Spain, Denmark, and New Jersey, USA.)

Location: נס ציונה

Comments

Johnson & Johnson is an equal opportunity employer promoting diversity and inclusion in the workplace.

This position may be suitable for any person subject to their qualifications and capabilities, regardless of (inter alia) gender, origin, ethnicity, sexual orientation, and/or disability.
מיקום : נס ציונה
בחירה
Associate Director, Global Regulatory Affairs, CMC

Description

Ethicon, Inc., is recruiting for an Associate Director, Global Regulatory Affairs, CMC for the Ethicon Biosurgery Franchise. The position will focus on biologic products, drug products, and drug-device combination products and may be based at any J&J site. Preferred locations are the J&J sites located at Ness Ziona, Israel or Raritan, New Jersey, United States. Other J&J locations throughout the U.S. and Europe will be considered. Remote work options may be considered on a case-by-case basis and if approved by the Company.

Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.

The Associate Director, Global Regulatory Affairs, CMC for Ethicon’s Biosurgery business unit will be responsible for leading a team of Regulatory professionals and partnering with R&D, Supply Chain, and other cross-functional team members and leaders to obtain and maintain Ethicon’s biologic, drug, and combination product portfolio globally through strategy development, excellence in submission execution, global health authority interactions, internal and external policy shaping, and growing and developing talent.

The products supported by this position are regulated worldwide as biologics, drugs, or high-risk medical device (combination products) which are intended to address a range of surgical challenges related to bleeding and sealing. Primary responsibilities will include:

Key Responsibilities:
• Lead, inspire, motivate, and manage a team of Regulatory CMC professionals to obtain and maintain market access for Chemistry, Manufacturing, and Controls (CMC) related changes to Ethicon Biosurgery biologic, drug, and combination products. (Currently this position has 3 direct reports (2 permanent staff, 1 contract staff) and responsibility for an overall team of 12 individuals, including both permanent and contract staffing).
• Mentor, coach, train, and develop technical and professional skills of the Regulatory CMC team.
• Maintain up-to-date understanding of global biologic, drug, and combination product regulations and guidance documents and advise Regulatory Affairs team and internal stakeholders on the interpretation and application of health authority expectations.
• Oversee assessment and communication of global CMC changes, strategies, risks, and requirements to internal business partners and leadership teams.
• Clearly and timely communicate compliance issues to Regulatory Management and business leadership that could affect registration or regulatory compliance.
• Active role on various leadership teams, including Ethicon Biosurgery Regulatory leadership team and Supply Chain leadership teams to maintain close alignment between supply chain strategy and regulatory compliance and timelines.
• Oversee the strategy development, health authority negotiations, submission content, and post market commitments for U.S., EU, and Israel CMC-related regulatory filings.
• Partner with regional Regulatory leaders on regulatory strategy and submissions to successfully obtain and maintain marketing approvals for all other markets.
• Partner with external manufacturers and strategic external partners to communicate CMC changes, evaluate impact of changes, and ensure joint regulatory responsibilities are fulfilled and compliant.
• Lead Health Authority meetings for key markets and interact with Health Authorities regarding product regulatory filings.
• Partner with regional leaders and the Regulatory Affairs Policy Intelligence team to monitor the regulatory environment globally and assess and communicate the impact of current and emerging regulations on the company's portfolio of products, define the future vision, and drive innovative thinking.
• Evaluate the impact of current and emerging standards and regulations, assess the most effective and efficient strategies for obtaining or maintaining product registrations globally, and communicate changes and impact to cross-functional business partners.
• Demonstrate a deep scientific and technical understanding of products under the scope of responsibility to provide strategic guidance and support for product development and life-cycle management of products.
• Integrate changing, complex, and/or ambiguous information for effective decision-making and clearly communicate challenges and solutions to stakeholders to achieve strategic and/or project goals.
• Collaborate with Quality partners regarding product non-conformance and quality issues by contributing to internal investigation and risk management reviews.
• Manage, oversee, and balance resource allocation and budget across critical projects.
• Influence and collaborate to bring about process and technical improvements within the organization.
• Represent the company and influence regulations and health authority guidance through industry trade association(s) in partnership with the Policy Intelligence team.
• Ensure that company policies, procedures and practices are compliant with appropriate regulatory requirements.

Requirements

Education:
• Bachelor’s/undergraduate degree is required.
• Advanced degree is a plus.
• Degree in a technical related discipline (e.g. biological, pharmaceutical, or chemical sciences) is preferred.

Experience and Skills:
• A Bachelor's degree and at least 10 years of regulated healthcare industry experience, or an advanced degree and a minimum of 7 years of regulated healthcare industry experience is required.
• Previous experience with biologic or drug Regulatory Affairs is required.
• Previous experience with medical device and/or combination product regulatory affairs is preferred.
• Demonstrated track record representing your function on cross-functional or leadership teams is required.
• Previous experience developing and executing regulatory strategies that align with business deliverables is preferred.
• Previous experience leading, inspiring, and developing a team is required.
• Previous experience preparing for and/or participating in Health Authority meetings or negotiations (FDA, EMA and other health authorities) is required.
• Previous experience working with professional trade associations or external policy shaping is preferred.

Job Requirements:
• High-level verbal and written communication skills is required.
• Up to 10% travel is required. (Primary locations for travel may include Israel, Spain, Denmark, and New Jersey, USA.)

Location: נס ציונה

Comments

Johnson & Johnson is an equal opportunity employer promoting diversity and inclusion in the workplace.

This position may be suitable for any person subject to their qualifications and capabilities, regardless of (inter alia) gender, origin, ethnicity, sexual orientation, and/or disability.
מיקום : נס ציונה
בחירה
מהנדס/ת אבטחת איכות מנוסה

תאור המשרה

לחברת אומריקס ביו-פרמצבטיקה דרוש/ה מהנדס/ת אבטחת איכות מנוסה (QE) לנס ציונה.
תיאור המשרה:
בחינה של תהליכים- תהליכי איכות ותהליכי יצור, זיהוי וביצוע פעולות נדרשות בתהליך האיכות.
תמיכה שוטפת במחלקות האתר - הנדסה, אחזקה, וולידציות, מעבדה - אישור מסמכים, פרוטוקולים ודוחות, בקרות שינוי וחריגות.
ניתוח סיכונים ותמיכה בחקירות
ניתוח מגמות ונתוני איכות
כתיבת סקירות שנתיות של מערכות ומוצרים

דרישות וכישורים

תואר הנדסי או תואר ראשון, שני בתחומי מדעי החיים - חובה
ניסיון של 4 שנים לפחות באבטחת איכות -חובה.
ניסיון בעבודה בתנאי GMP מחברה פרמצבטית - יתרון
אנגלית ברמה גבוהה כולל כתיבה-חובה
ידע באופיס ברמה טובה-חובה.
יחסי אנוש מעולים ומסוגלות לעבודה בעומס ולחץ
משרה מלאה עם נכונות לשעות נוספות עפ"י הצורך

מיקום: נס ציונה

הערות

אומריקס הוא מעסיק המקדם שוויון הזדמנויות וגיוון במקום העבודה.
משרה זו עשויה להתאים לכל אדם באשר הוא בהתאם לכישוריו ויכולותיו, בין היתר, ללא קשר למגדר, מוצא, שיוך אתני, נטיה מינית ו/או מוגבלות.
מיקום : נס ציונה
בחירה
internal move only - QA Batch Release specialist

Description

• Review and Release of Batch files for intermediate and final products. Yield monitoring.
• Review and approval of shipping related documents.
• Approval and release of shipments.
• Review and approval of SOPs for production.
• Supporting production related deviations
• Support on site audits
• Support site projects and initiatives
• Leading or participating in risk assessments processes.
• Perform QA Inspections on the shop floor
• Assesses current quality systems and recommends improvements in order to enhance quality and reduce cycle time.
• Performed trainings on subjects such as GMP, GDP, DI

Requirements

• University/Bachelor's Degree or Equivalent
• over 2 Years Work Relevant Experience in QA from Pharmaceutical companies
• High level of both English and Hebrew

Location: נס ציונה

Comments

Omrix is an equal opportunity employer promoting diversity and inclusion in the work place.
This position may be suitable for any person subject to their qualifications and capabilities, regardless of (inter alia) gender, origin, ethnicity, sexual orientation, and/or disability.
מיקום : תל השומר
בחירה
QA Batch Release specialist

Description

• Review and Release of Batch files for intermediate and final products. Yield monitoring.
• Review and approval of shipping related documents.
• Approval and release of shipments.
• Review and approval of SOPs for production.
• Supporting production related deviations
• Support on site audits.
• Leading or participating in risk assessments processes.
• Performed in process Inspection
• Assists in the development, implementation and review of standard operating procedures for interactions with contract manufacturers.
• Assesses current quality systems and recommends improvements in order to enhance quality and reduce cycle time.
• Performed trainings on subjects such as GMP, GDP, DI

Requirements

• University/Bachelor's Degree or Equivalent
• over 2 Years Work Relevant Experience in QA from Pharmaceutical companies
• High level of both English and Hebrew

Location: תל השומר

Comments

Omrix is an equal opportunity employer promoting diversity and inclusion in the work place.
This position may be suitable for any person subject to their qualifications and capabilities, regardless of (inter alia) gender, origin, ethnicity, sexual orientation, and/or disability.
מיקום : תל השומר
בחירה
Quality Engineer

Description

Omrix Biopharmaceuticals is seeking a Quality Engineer, for our Tel Hashomer site. Reports to QA Manager. In this role you will:
Perform evaluation of Non-Conformance
Review completeness of documents such as: procedures, forms, protocols, and validations
support projects as required
Support quality systems issues (CAPA's, Non-Conformance and changes)
Perform risk evaluation and product impact assessment
Writing annual reviews for products and systems
Support audits preparation (internal & external)
GMP/ Compliance Improvements
Ensure compliance with Omrix and JNJ quality systems requirements

Requirements

Engineer or B.Sc./M.Sc. in life science - a must
experience in GMP – an advantage
Minimum of 2 years of Experience in Quality Assurance
Great interpersonal skills
Organized and meticulous
Independence and prioritizing abilities
High technical-oriented skills and writing ability both in English and Hebrew

Location: תל השומר

Comments

Omrix is an equal opportunity employer promoting diversity and inclusion in the workplace.
This position may be suitable for any person subject to their qualifications and capabilities, regardless of (inter alia) gender, origin, ethnicity, sexual orientation, and/or disability.

מיקום : נס ציונה
בחירה
Assistant Controller

Description

Omrix Biopharmaceuticals, a Johnson & Johnson Company, is looking for a vital, dynamic, and reliable Assistant Controller

Main Responsibilities:
• Preparation of the statutory financial statements and tax return
• Taking part in the monthly and quarterly reporting in accordance with US GAAP
• Work closely with the Company's external auditors during financial and tax audits
• Responsible for tax reporting, collaborating with J&J Tax Corporate
• Leading SOX compliance and ensure proper implantation control processes
• Lease accounting calculations
• Ad-Hoc accounting and finance-related projects as needed

Requirements

• A Certified Public Accountant (CPA) with a BA in accounting/finance – a must
• Experience as an Assistant Controller from a global company – a big advantage
• Solid knowledge and experience with US GAAP and local taxation – a must
• Experience with SOX
• Strong English skills - both oral and written – a must
• Working knowledge of MS Office (especially Excel and PowerPoint)
• Ability to work under pressure in a multi-tasking environment and meet deadlines
• Attention to details and problem-solving ability

Location: נס ציונה

Comments

Omrix is an equal opportunity employer promoting diversity and inclusion in the work place.
This position may be suitable for any person subject to their qualifications and capabilities, regardless of (inter alia) gender, origin, ethnicity, sexual orientation, and/or disability.
מיקום : נס ציונה
בחירה
Communication & Engagement Lead

Description

Omrix Biopharmaceuticals is a leader in innovation and specializes in the development and production of life-saving combination products (medical device and human plasma derived product).
We are looking for an Engagement & Communication Lead to join our HR team, to lead all communication, employer brand and employees' engagement strategic plans and activities, for enhancing Omrix's growth and development.
This is a superb opportunity to work with stakeholders within the company – management board members, leadership team, front line managers and employees.

Position Description:
Communication, Employer Branding and DEI
• Design, plan and implement internal communication strategy with strong focus on driving business alignment and employee engagement programs, according to business priorities and values;
• Build and execute pulse and engagement surveys and provide insight on our company's culture.
• Design and implement business change management communication strategic plans for internal and external audiences
• Coach business leadership team and managers on communication, change management and Engagement.
• Drive company brand awareness and reputation through social media channels; Write content and coordinate timely posts and updates in social media pages-Linkedin, Facebook and Yammer
• Create materials and develop strategy to increase online engagement among Omrix’s employees by creating ambassadors' programs.
• DE&I communication partner supporting JNJ IL ERG's s and DE&I's country council
Employee's engagement, Welfare & Wellbeing
• Build, execute and supervise Omrix’s strategy annual wellbeing plan as “One Omrix” including social events, team building events, celebrations, lectures, giveaways, holiday toast and family activities
• Negotiate with service providers and suppliers; Manage and monitor wellbeing budgets

Requirements

• Relevant Academic Degree – a must
• At least 5 years' experience at a leading position of Employee Engagement, Communication and Employer Branding - A must
• Familiarity with Social Digital platforms – a must
• Proven Experience in Project Management
• Excellent verbal and written communication skills (both English and Hebrew) - A must

Location: נס ציונה

Comments

Omrix is an equal opportunity employer promoting diversity and inclusion in the work place.
This position may be suitable for any person subject to their qualifications and capabilities, regardless of (inter alia) gender, origin, ethnicity, sexual orientation, and/or disability.