GMP Quality Assurance Lead
2 weeks ago
SpringWorks Therapeutics is seeking a committed professional to take on the role of GMP Quality Assurance (QA) Manager. This position is crucial for ensuring the quality and regulatory compliance of products distributed by SpringWorks.
Key Responsibilities:
- Engage with both internal teams and external partners to ensure production schedules are met
- Oversee the quality unit's review and approval processes for documentation
- Collaborate with Qualified Persons to facilitate product distribution
- Monitor stability protocol data and manage expiry dating
- Lead investigations into deviations and complaints, implementing necessary change controls
- Participate in compliance audits and assessments of suppliers
- Establish and maintain performance metrics for Contract Manufacturing Organizations (CMOs)
- Contribute to the preparation of Annual Product Reviews
- Execute other assigned responsibilities as needed
Qualifications:
- Bachelor's Degree in a scientific or technical field
- Minimum of 5 years' experience in Quality Assurance within the pharmaceutical or regulated industry
- Experience in overseeing quality for CMOs
- In-depth knowledge of quality systems
- Understanding of relevant regulatory requirements
- Exemplify the core values of SpringWorks
- Excellent communication abilities
- Willingness to travel occasionally and work in an office environment
Compensation:
Attractive salary commensurate with experience and qualifications, along with the possibility of an annual bonus. A comprehensive benefits package is available.
Equal Employment Opportunity Policy:
SpringWorks is dedicated to providing equal opportunities for all employees and applicants, irrespective of their background or any legally protected characteristics.
GDPR Statement:
Personal data collected during the recruitment process will be handled lawfully and stored securely.
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