Omrix, a Biopharmaceutical company, is seeking a Supplier Quality Lead (GROW).
GROW position until the end of 6/2021
This position will be responsible for the approval planning, execution, and documentation of the qualification and monitoring for suppliers and/or external manufacturers who input into the Ethicon Biosurgery Supply Chain for the manufacture of blood product Intermediates, APIs, or drug products.
Providing Quality and Compliance oversight by ensuring quality standards are achieved and maintained at our Suppliers and External Manufacturers to meet J&J requirements and for inclusion on MD Global Biologics Approved Supplier List
This oversight includes ensuring continuous compliance with relevant regulatory health authority requirements, effective risk management, strategy development and execution, and effective collaboration between R&D, Operations, Procurement, TechOps, Regulatory Affairs and other technical disciplines (EHS). Functions and activities include quality assurance review and approval functions (such as Change Control, Deviation Handling), compliance audit activities, creation and management of risk mitigation plans for suppliers and external manufacturers.
This position requires the ability of building collaboration and teamwork across the local and global Ethicon Biosurgery organization, and it interfaces Ethicon Biosurgery Supplier Quality with the quality unit of suppliers and external manufacturers.
This position reporting to Supplier Quality Manager ETH Biosurgery.
Oversees compliance of existing supplier base and executes upon Supplier Quality Systems requirements assuring adequate controls over sourced goods and services. Effects and permanently maintains inspection readiness at third-party manufacturers and material-suppliers. Supporting of third-party manufacturers and suppliers during regulatory inspections and audits and during the development of corrective action plans.
Surveillance on the quality and compliance status for all suppliers and/or external manufacturers of raw materials, packaging materials, intermediates, excipients, APIs and service providers.
Performing audits at suppliers and external manufacturers
Management of Change related to supplier and/or external manufacturers
Assessment of deviations, corrective and preventative actions, and complaints concerning suppliers and external manufacturers
Provision of all information needed for the release/reject of suppliers.
Establishment and periodic review of Quality Agreements
Initial assessment and qualification of suppliers and external manufacturers for new product introductions, and establishment of initial Qualification Statements
Periodic performance measurement for suppliers and external manufacturers
Help in preparing external manufacturers for and support during health authority inspections
Supplier Quality representative and subject matter expert (SME) during regulatory audits at Ethicon Biosurgery sites
A minimum of 5 years' working experience with 2 years' experience in MD/biological industry, commercial manufacturing and/or R&D environment;
Experience in Quality Assurance, Quality Control and/or Compliance; previous experience in a Supplier Quality role is strongly preferred.
Having the ability to provide cGMP compliance support to contract manufacturers by investigating and resolving quality issues;
Excellent interpersonal, written, oral and presentation skills (English).