Job Description
Join BioInnovate Labs, a leader in cutting-edge pharmaceutical research, as we develop next-generation therapies that transform patient care. Our Cambridge-based team operates at the intersection of innovation and regulatory excellence, where your expertise will directly impact global health outcomes. We foster a collaborative environment where scientific rigor meets operational efficiency, offering competitive benefits and continuous professional development.
Responsibilities
- Oversee GMP compliance across manufacturing processes and documentation systems
- Lead internal/external audits for FDA, EMA, and other regulatory bodies
- Develop and implement risk-based quality management strategies
- Coordinate deviation investigations and CAPA systems
- Maintain electronic batch records and quality documentation
- Mentor junior QA staff and train cross-functional teams
- Represent QA during regulatory inspections and client interactions
Qualifications
- Bachelor's degree in Pharmacy, Chemistry, or related scientific field
- 5+ years of pharmaceutical QA experience in GMP environments
- Certified Quality Auditor (CQA) or equivalent certification
- Expert knowledge of 21 CFR Part 210/211, ICH Q7, and EU GMP
- Proven experience with regulatory inspections and compliance
- Advanced proficiency in quality management software (e.g., TrackWise)
- Strong analytical skills with attention to detail
- Excellent communication and leadership abilities