Quality Assurance Manager
2 days ago
SpringWorks Therapeutics is a commercial-stage biopharmaceutical company dedicated to developing and delivering life-changing medicines for people with severe rare diseases and cancer. Our precision medicine approach enables us to rapidly advance our lead product candidates into late-stage trials and collaborate with innovators in industry and academia to unlock the full potential for our portfolio and create more solutions for patients with cancer.
About the RoleWe are seeking a highly motivated and experienced Quality Assurance professional to join our team as a GMP Quality Assurance Manager. This individual will report to the Senior Director Global GMP Quality and play a critical role in maintaining and supporting a reliable and compliant supply of SpringWorks products to clinical, compassionate use, and commercial distribution channels.
Key Responsibilities- Work with internal and external stakeholders to meet SpringWorks' timelines for drug substance and finished drug product release.
- Manage SpringWorks Quality Unit review and approval of CMO master documentation, executed batch records, QC release records, and stability test records for the manufacturing of drug substance and drug product.
- Support Qualified Persons (QPs) in QP certification for distribution of SpringWorks products to EU/UK distribution channels.
- Perform QA oversight of stability protocol data review and expiry dating of SpringWorks products.
- Work with internal stakeholders and/or CMOs to perform deviation/complaint investigations in support of product quality.
- Develop and maintain CMO performance metrics to demonstrate Sponsor oversight.
- Contribute to Annual Product Reviews for commercial products.
We are seeking a highly motivated and experienced Quality Assurance professional with a Bachelor's Degree in a scientific or technical discipline and 5+ years of experience working in Quality Assurance in a pharmaceutical/regulated environment/industry. Prior experience overseeing CMO quality for batch record review, deviation investigation resolution for drug substance and finished drug product is required. Small molecule experience is preferred. The ideal candidate will have a working knowledge of key quality systems such as change controls, deviations, CAPAs, product complaints, and supplier qualification. Knowledge of US FDA 21CFR 210/211 regulations, ICH guidance, and Eudralex GMPs and related practical application is also required.
What We OfferSpringWorks offers a comprehensive benefits package, including competitive compensation, annual cash bonuses, and equity grants, 401K matching, fully covered medical, dental, and vision plans, and a full week of holiday break at year end. We are committed to fostering a culture of belonging and diversity, equity, and inclusion.
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