Manager of Quality Assurance Operations
1 week ago
SpringWorks Therapeutics is seeking a committed professional to assume the role of GMP Quality Assurance (QA) Manager. This position is pivotal in guaranteeing the quality and regulatory compliance of products distributed through various channels.
Key Responsibilities:
- Engage with both internal teams and external partners to ensure production schedules are met
- Oversee the quality unit's review and sanctioning of documentation
- Collaborate with Qualified Persons to facilitate product distribution
- Supervise stability protocol data and determine expiry dates
- Lead investigations into deviations and complaints, implementing necessary change controls
- Participate in compliance audits and evaluations of suppliers
- Establish and uphold performance metrics for Contract Manufacturing Organizations (CMOs)
- Contribute to the Annual Product Review process
- Execute other responsibilities as assigned
Qualifications:
- Bachelor's Degree in a scientific or technical field
- Minimum of 5 years' experience in Quality Assurance within the pharmaceutical or regulated sectors
- Previous experience 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:
Attractive salary commensurate with experience and qualifications, along with the possibility of 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 accordance with legal standards and stored securely.
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