Senior Quality Product Manager - Permanent - Waltham, MA
Proclinical is seeking a Senior Quality Product Manager to join a leading pharmaceutical company. This is a permanent position located in Waltham, MA.
Primary Responsibilities:
The successful candidate will ensure end-to-end product quality for designated products, encompassing all aspects associated with manufacturing and testing of product components, drug substance, and drug product. The role involves providing Quality oversight to ensure manufacturing and testing is conducted in compliance with all applicable filings, regulations, and cGMPs.
Skills & Requirements:
- BS/MS in relevant scientific or engineering discipline.
- Minimum of 8 years of relevant experience in the pharmaceutical industry, including time spent in a Quality role in a GMP environment.
- Working knowledge of batch release processes and associated accountabilities.
- Experience in both small molecules and biologics, as well as involvement in process development of ADCs is preferable.
- Experience working with third-party manufacturers is preferable.
- Knowledge of cGMP and regulatory requirements for ADC manufacturing and testing.
- Demonstrated effectiveness in partnership relationships in the areas of communication, influence, and negotiation.
- Demonstrated effectiveness in problem-solving, decision-making, and managing a diverse set of activities across multiple stakeholders.
- Ability to travel, as required, to support partner execution.
The Senior Quality Product Manager will:
- Acquire and maintain end-to-end product knowledge for designated product(s).
- Partner with relevant teams to manage potential quality issues during development, manufacturing, and testing.
- Collaborate with key CMC stakeholders on the development of the overall control strategy.
- Participate in Stability Review Committee and Specification Review Board meetings.
- Review and approve process validation protocols and reports, as well as master batch records.
- Assist in the disposition of all batches of antibody, payload, linker, drug substance, and drug product.
- Review and approve all relevant change controls, deviations, investigations, and associated CAPAs.
- Lead complaint investigations and recalls, as necessary.
- Monitor compliance to respective Quality Agreements and escalate issues when necessary.
- Lead the risk management process for designated product(s).
- Coordinate the development of Annual Product Reviews and FDA metrics for designated product(s).
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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