Quality Assurance Supervisor for GMP
1 week 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 across various distribution channels.
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 Annual Product Review process
- Execute other assigned responsibilities as needed
Qualifications:
- Bachelor's Degree in a scientific or technical field
- Minimum of 5 years of experience in Quality Assurance within the pharmaceutical or regulated industry
- Previous experience in managing CMO quality
- In-depth understanding of quality systems
- Knowledge of applicable regulations
- Exemplify the core values of SpringWorks
- Excellent communication abilities
- Willingness to travel occasionally and work in an office environment
Compensation:
Competitive salary commensurate with experience and qualifications, along with the potential for an annual bonus. A comprehensive benefits package is also provided.
Equal Employment Opportunity Policy:
SpringWorks is dedicated to ensuring equal opportunities for all employees and applicants, irrespective of background or legally protected characteristics.
GDPR Statement:
Personal data collected during the recruitment process will be processed in a lawful manner and stored securely.
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