Director of Quality Assurance
3 weeks ago
Director of Quality Assurance
Sterling Life Sciences is seeking a highly skilled Director of Quality Assurance to lead their quality management team. The ideal candidate will have a strong background in quality management and a proven track record of ensuring process reliability and compliance with regulatory requirements.
Key Responsibilities:
- Provide technical quality support for internal and external teams and projects
- Ensure robustness of process to meet CPPs and CQAs
- Oversee analytical methods validation and process validation for insulin analog drug substance and product
- Review and approve procedures, master batch records, and other documentation
- Review and approve quality system records, including change requests, deviations, and CAPA
- Provide quality input to new facility design changes
- Decision-maker for validation/qualification of insulin biosimilars and escalation of issues to management
- Oversee disposition of drug substance
- Ensure manufacturing and QC adherence to company policies and procedures, regulatory licenses, industry standards, and GMP regulations
- Represent QA during site health authority inspections and business forums
- Ensure staff training and development
- Partner with and influence other departments and functions to implement ongoing product and process robustness
Critical Requirements:
- A university degree is required
- Appropriate full-time work experience is mandatory
- Recent experience in the pharmaceutical industry is strongly preferred
- Preference will be given to candidates with recent experience in quality management
This is a highly competitive opportunity for a seasoned quality professional to join a well-established company in the pharmaceutical industry.
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