Omrix Biopharmaceuticals is seeking a Senior Manager, Pharmacovigilance
Worldwide responsibility for the establishment and execution of the Ethicon Biosurgery Quality and Pharmacovigilance System compliant with international regulations for Biologic products and accessories, including, but not limited to:
•Complaint handling, investigations and AE reporting for Omrix, Limerick and Bioseal
•Collaboration with Regulatory Affairs, Medical Affairs, Clinical Development and Quality Assurance to support the identification of issues and the necessary actions to assure continued safety and efficacy of marketed products worldwide.
•Continued enhancement of the Biosurgery Quality System in response to changing regulations, QS performance and improvement opportunities, and business needs, with consideration of the interaction of the Biologic Quality System with the Ethicon Franchise Quality System.
This position will report directly to the Senior Director, Ethicon Quality Systems, and has the responsibility to supervise the Quality Systems and Pharmacovigilance group.
DUTIES & RESPONSIBILITIES
Under limited supervision, and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
•Provides strategic direction to global business partners and senior management on the execution of pharmacovigilance and quality systems related topics. Adjust and monitor strategic direction in response to changing regulatory and business environment.
•Proactively communicate potential safety signals and provide strategic direction for addressing concerns to global business partners and senior management.
•Develop pharmacovigilance and quality system strategies for current and emerging markets
•Lead interactions with global Health Authorities with respect to post-market commitments, safety reporting and field actions related to safety & quality issues
•Represent Pharmacovigilance and Biosurgery Quality Systems during internal and external audits.
•Implement the quality system strategy and standards for the Biosurgery business platform across all Biosurgery locations globally. Identify opportunities to leverage Ethicon Franchise and Enterprise capabilities, including process integration.
•Harmonize, maintain and continuously improve quality systems, including quality manual, Management Review, configuration management, change control, records management and associated technologies and procedures that support the development, manufacture and delivery of high-quality products in order to meet J&J and external regulatory requirements, as well as customer expectations.
•Monitor Quality System and Pharmacovigilance performance measures and provide strategic reaction to negative trends. Utilize data and changing internal and external environment to identify any new performance measures and identify measures that can serve as leading indicators of issues.
•Represent Biosurgery Quality Systems and Pharmacovigilance in the Ethicon Quality System organization and on Enterprise teams and initiatives.
•Participate on Ethicon Franchise Quality Systems and Biosurgery Quality leadership teams.
•Recruitment, training and assessment of direct staff
•Responsible for communicating business related issues or opportunities to next management level
•For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
•Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
•Performs other duties assigned as needed
EXPERIENCE AND EDUCATION*
•MS/MA or higher in a scientific/technical field.
•5+ Years of job-related experience
•3-5 years supervisory experience
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*
•Ability to work independently
•Ability to communicate (written and verbally) effectively with all levels of management and across multiple functions and geographies
•Management/Supervision of technical and non-technical personnel.
•Understanding of interaction of the comprehensive Quality System across different processes and functions
•Specific understanding of EU GVP, ICH Q8/Q9/Q10, 21CFR 210/211/600, QSR and ISO 13485 requirements
•Good computer skills and basic statistical knowledge
•Experience in pharmaceutical medicine, including drug safety is preferred
LOCATION & TRAVEL REQUIREMENTS
•This position may be based at either the Somerville (NJ) or Cincinnati (OH) site, and will require 25-35% travel, including some international travel.