Senior QA testing functional scenarios at DOMVS iT. Collaborating closely with Product and Development teams in an agile environment.
About the role
- QA Product Manager ensuring quality assurance for pharmaceutical products in collaboration with cross-functional teams. Leading third-party manufacturing quality efforts and compliance with regulatory standards.
Responsibilities
- Lead Quality Assurance efforts for pharmaceutical products manufactured by third-party manufacturers
- Develop and Implement Quality Assurance strategies, policies, and procedures specific to third-party manufacturing
- Conduct rigorous assessments and audits of potential and existing third-party manufacturers
- Oversee and provide guidance on the design and execution of validation
- Provide technical guidance and support to third-party manufacturers regarding quality systems
- Collaborate with Regulatory Affairs teams to support product registrations
- Resolve quality issues and initiate investigations
- Perform batch record review and communicate adverse findings
- Manage the development of product specifications and sterility assurance practices
- Review and approve stability protocols and results
Requirements
- Bachelor's degree in Life Sciences (Biology, Microbiology, Pharmacy, Pharmaceutical Sciences, Chemistry, or a related field)
- Minimum of five (5) years of experience in pharmaceutical Quality Assurance, with experience in third-party manufacturing
- Sterile experience a plus
- Strong project management skills
- Excellent communication and interpersonal skills
- Experience with quality management software and tools such as Veeva
- Knowledge of pharmaceutical product development processes, supply chain management, and regulatory requirements for third-party manufacturing
Benefits
- Health insurance
- 401(k) matching
- Paid time off
- Flexible work arrangements
- Professional development opportunities
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