Quality Assurance Manager

1 month ago


Durham, North Carolina, United States SpringWorks Therapeutics Full time

At SpringWorks Therapeutics, we are seeking a highly motivated individual to fill the role of Quality Assurance Manager. This position will play a crucial part in ensuring the reliability and compliance of our products in clinical, compassionate use, and commercial distribution channels.

Key Responsibilities:

  • Collaborate with internal stakeholders and external partners to meet SpringWorks' timelines for drug substance and finished drug product release.
  • Manage the review and approval of master documentation for Contract Manufacturing Organizations (CMOs) and executed batch records, QC release records, and stability test records.
  • Work with Qualified Persons (QPs) to support 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.
  • Investigate deviations and complaints 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.
  • Contribute to Annual Product Reviews for commercial products.

Qualifications:

  • Bachelor's Degree in a scientific or technical discipline.
  • 5+ years of experience in Quality Assurance in a pharmaceutical or regulated environment.
  • Prior experience overseeing CMO quality for batch record review, deviation investigation resolution for drug substance and finished drug product.
  • Knowledge of US FDA 21CFR 210/211 regulations, ICH guidance, and Eudralex GMPs.
  • Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively.
  • Ability to travel occasionally.

Compensation:

The expected salary range for this position is $78,000.00 - $103,000.00. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by law.

We offer a comprehensive benefits package, including competitive compensation, annual cash bonuses and equity grants, 401K matching, and a full week of holiday break at year end.

At SpringWorks, we believe in fostering a culture of belonging and diversity, equity, and inclusion.



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