Quality Assurance Manager

2 weeks ago

Raleigh, North Carolina, United States SpringWorks Therapeutics Full time

About SpringWorks Therapeutics:

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 Role:

We are seeking a highly motivated individual to join our team as a GMP Quality Assurance (QA) Manager. This individual will report into the Senior Director Global GMP Quality and play an essential 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.
  • Initiate and implement change controls.
  • Participate in GMP compliance audits and complete risk assessments for supplier qualification.
  • Develop and maintain CMO performance metrics to demonstrate Sponsor oversight.
  • Contribute to Annual Product Reviews for commercial products.

Qualifications:

We are looking for a highly skilled and experienced individual 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 essential.

What We Offer:

SpringWorks offers a comprehensive benefits package, including competitive compensation, annual cash bonuses, and equity grants. We also offer a full week of holiday break at year-end and a comprehensive benefits package for our team and their families. We are committed to fostering a culture of belonging and diversity, equity, and inclusion.

SpringWorks Leadership Principles:

We are guided by our Leadership Principles, which include Change Steward, Excellence Driver, Growth Coach, and Community Builder. We believe in recognizing and rewarding performance, empowering teams, and creating a diverse, inclusive, and psychologically safe environment.

EEO Statement:

SpringWorks maintains an EEO Policy providing for equitable opportunities for employment and conditions of employment to all employees and applicants regardless of actual or perceived sex, gender, gender identity or expression, sexual orientation, partnership status, marital status, familial status, pregnancy status, race, color, national origin, ancestry, caste, religion, religious creed, age, alienage or citizenship status, veteran status, military status, physical or mental disability, past or present history of mental disorder, medical condition, AIDS/HIV status, sickle cell or hemoglobin C trait, genetic predisposition, genetic information, protected medical leaves, victims of domestic violence, stalking, or sex offense, political affiliation, and any and all other characteristics or categories protected by applicable federal, state, or local laws.

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