Quality Assurance Manager

2 days ago

Raleigh, North Carolina, United States SpringWorks Therapeutics Full time

About SpringWorks Therapeutics:

SpringWorks is a commercial-stage biopharmaceutical company that applies a precision medicine approach to developing and delivering life-changing medicines for people with severe rare diseases and cancer.

The company has a diversified targeted oncology pipeline spanning solid tumors and hematological cancers, including clinical trials in rare tumor types and highly prevalent, genetically defined cancers.

SpringWorks' strategic approach and operational excellence in clinical development have enabled it to rapidly advance its lead product candidates into late-stage trials and enter into multiple collaborations with innovators in industry and academia to unlock the full potential for its 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.
  • 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 motivated 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, and working knowledge of key quality systems such as change controls, deviations, CAPAs, product complaints, and supplier qualification is necessary.

Knowledge of US FDA 21CFR 210/211 regulations, ICH guidance, and Eudralex GMPs and related practical application is also required.

We are committed to fostering a culture of belonging and diversity, equity, and inclusion.

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.

We treat all employees and applicants fairly in the selection process by giving all employees and applicants the same opportunities for employment.

This Equal Employment Opportunity Policy applies to all aspects of employment, including recruitment, hiring, placement, job assignment, promotion, termination, transfer, leaves of absence, compensation, discipline, and access to benefits and training.

Any violation of this Policy will result in disciplinary action up to and including termination of employment.

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