Job Description
Are you ready to shape the future of medicine? BioVanguard Therapeutics is seeking a high-caliber Senior Quality Assurance Specialist to join our elite clinical development team in Cambridge, MA. In this role, you will play a pivotal part in ensuring our groundbreaking pharmaceutical products meet the highest global regulatory standards, safeguarding patient health and driving innovation.
We offer a dynamic, collaborative culture where your expertise in cGMP and clinical compliance will be the cornerstone of our success. Join us as we accelerate life-changing therapies to market.
Responsibilities
- Oversee and maintain Quality Management Systems (QMS) in alignment with current cGMP and FDA/EMA regulations.
- Conduct thorough internal and vendor audits to ensure rigorous compliance across the supply chain.
- Review and approve batch production records, analytical reports, and stability data for clinical and commercial releases.
- Lead CAPA investigations, root cause analyses, and implement effective corrective measures for deviations.
- Collaborate cross-functionally with R&D and Manufacturing to ensure Quality by Design (QbD) principles are integrated.
- Prepare comprehensive documentation for regulatory filings and participate in health authority inspections.
- Provide mentorship and quality guidance to junior staff to foster a culture of excellence and compliance.
Qualifications
- Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biology, or a related Life Sciences discipline.
- Minimum of 5-7 years of direct experience in Quality Assurance within the pharmaceutical or biotechnology industry.
- Expert-level knowledge of 21 CFR Part 210/211 and ICH Q7/Q10 guidelines.
- Proven track record in managing complex investigations and successfully leading regulatory inspections.
- Strong analytical mindset with meticulous attention to detail and impeccable documentation standards.
- Excellent communication and stakeholder management skills, capable of influencing senior-level decision-making.
- Professional certification (e.g., ASQ CQA or CMQ/OE) is highly preferred.