Quality Assurance GMDP Manager

Proclinical is seeking a Quality Assurance GMDP Manager for a leading CRO located in Paulsboro, NJ.

Must be eligible to work or be a citizen in the US.

Job Responsibility:

• Has oversight of / reviews and approves deviations relating to GMP and GDP operations within the US
• Has oversight of / reviews and approves changes relating to GMP and GDP operations within the US
• Ensures all vendors involved in the GMP and GDP supply chain (Products, materials, components, services, Suppliers) are qualified in accordance with company's Vendor assurance programs.
• Ensures Supply Chain mapping is undertaken for all product supply chains.
• Has oversight of the management of Product Quality Complaints (PQCs) resulting from supply / use of products manufactured (labelled & packed) or wholesaled in or from the US
• Ensures the delivery of the Internal Audit / Self Inspection program to GMP and GDP operations and processes within the U operation.
• Ensures that critical equipment, systems and processes are adequately qualified and validated for their intended use.
• Keeps current on performance of the QMS and emerging quality trends / risks such as complaints, audit findings, deviations, non-conformance, etc. through participation in global management review meetings.
• Leads the US facility Quality Management Review activities.
• Keeps current on overall performance of the PQS and emerging quality trends / risks.
• Supports the establishment and development of Quality Key Performance Indicators.
• Review and approval of artwork files, for printed packaging components
• Review and approval of packaging component specifications
• Ensuring systems are in place for the control of Product Specification Files
• Ensures overall compliance of labelling and packaging operations to GMP
• Review / approval of Master packaging records
• Review / approval of Batch packaging records
• Overall accountability for Quality Control activities on materials and products used in labelling and packaging operations including In Process Controls (IPCs) and finished product sampling.
• Named as the Designated Representative on the New Jersey State Wholesaler Registration.
• The following responsibilities are assumed by the Designated Representative:
• Ensuring that the quality, safety and traceability and pedigree of medicinal products is maintained within the supply chain, in compliance with the track and trace requirements within the US Drug Supply Chain Security Act (US DSCSA).
• Ensuring that a quality management system is implemented and maintained.
• All GDP relevant SOPs are reviewed and approved.
• carry out their duties in such a way to ensure that GDP and public service obligations are met.
• Focusing on the management of authorized activities and the accuracy and quality of records.
• Ensuring that initial and continuous training programs are implemented and maintained.
• Coordinating and promptly performing any recall operations for medicinal products received or supplied by the US business.
• Ensuring that suppliers, customers, and outsourced contractors are approved and Bona Fide prior to use.
• Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.
• Deciding on the final disposition of returned, rejected, recalled or falsified products
• Approving any returns to saleable stock.
• Maintain oversight of any disposable of product using an approved outsourced provider
• Ensuring that any additional requirements imposed on certain products by national law are adhered to.

Skills and Requirements:

• Scientific degree (including either pharmacy, pharmaceutical sciences, chemistry, biology or related) (essential).
• Impressive, demonstrable track record & skills/experience gained within similar position(s) (Management level quality roles covering GMP and GDP requirements) (essential).
• Good understanding of the pharmaceutical industry, ideally with experience of Investigational New Drugs (INDs)
• Working knowledge of processes and systems used in the manufacture and distribution of medicinal product. (desirable).
• Credible & confident communicator (written and verbal) at all levels (essential).
• Commercially astute & highly customer focused (essential).
• Strong analytical & problem-solving ability (essential).
• Hands-on approach, with a 'can do' attitude (essential).
• Strong organizational skills: ability to prioritize, with good time management skills (essential).
• Good attention to detail & ability to work accurately in a busy, demanding environment (essential).
• Ability to work with commonly used IT platforms and packages (essential).
• Strong team player (essential).

If you are having difficulty in applying or if you have any questions, please contact Christina Chung at (+1) 857-233-9215 or c.chung@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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