Quality Assurance Manager
1 month ago
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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