We are seeking a skilled GMP Quality Assurance Manager to join our client. Our client is a new emerging Rare Disease Biotech that is getting ready for a launch! The ideal candidate will bring extensive experience in quality assurance within the biotech field, specifically with commercial quality complaints, solid oral dosage forms, and batch record review. See below for more responsibilities!
Key Responsibilities:
- Oversee and manage quality assurance activities to ensure compliance with GMP regulations and industry standards.
- Review and approve batch records and ensure the accurate documentation of all production processes.
- Handle and resolve commercial quality complaints, implementing corrective and preventive actions as needed.
- Collaborate closely with quality control teams to ensure alignment with quality assurance practices.
- Conduct internal audits and participate in external audits as required.
- Provide guidance and training to team members on GMP practices and quality standards.
- Develop and maintain quality assurance policies and procedures.
Qualifications:
- Bachelor’s degree in a related field (e.g., Life Sciences, Chemistry, Engineering).
- 7+ years of proven experience in a GMP quality assurance role within the biotech or pharmaceutical industry.
- Solid experience with solid oral dosage forms and batch record review.
- Demonstrated experience in managing or working within quality control environments.
- Strong knowledge of regulatory requirements and industry standards.
- Excellent problem-solving skills and attention to detail.
- Strong communication and leadership abilities.
