Job Description
Are you a seasoned Quality Assurance professional with a passion for ensuring the highest standards in pharmaceutical manufacturing? BioGen Pharma Solutions, a cutting-edge leader in innovative drug development, is seeking a dynamic and highly motivated Senior Pharmaceutical Quality Assurance Specialist to join our elite team in Boston, MA. This is an unparalleled opportunity to significantly impact patient lives by upholding rigorous quality and compliance standards across our advanced product portfolio.
At BioGen Pharma, we believe in fostering a culture of excellence, innovation, and continuous improvement. You will play a critical role in shaping our quality systems, driving GxP compliance, and collaborating with cross-functional teams to bring life-changing therapies to market. If you thrive in a fast-paced environment, possess exceptional attention to detail, and are committed to pharmaceutical integrity, we want to hear from you!
Join us and contribute to a healthier future!
Responsibilities
- Lead and execute quality assurance activities to ensure compliance with cGMP, FDA regulations, and international standards (e.g., ICH, EMA).
- Oversee and conduct internal and external audits, including vendor qualification and management, identifying areas for improvement and driving corrective actions.
- Develop, review, and approve critical quality documents, including SOPs, batch records, validation protocols, and change control documentation.
- Investigate deviations, non-conformances, and out-of-specifications, performing root cause analysis and implementing effective CAPAs.
- Provide expert QA guidance and support to manufacturing, R&D, and regulatory affairs teams throughout the product lifecycle.
- Participate in regulatory inspections (FDA, EMA, etc.) and ensure timely and accurate responses to observations.
- Mentor junior QA staff and contribute to the continuous improvement of the Quality Management System (QMS).
Qualifications
- Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy, Engineering); Master's degree preferred.
- 5+ years of progressive experience in Quality Assurance within the pharmaceutical or biotechnology industry.
- In-depth knowledge of cGMP regulations (21 CFR Parts 210, 211), ICH guidelines, and other relevant international quality standards.
- Proven track record of successful participation in regulatory audits (FDA, EMA, etc.).
- Strong understanding of quality systems principles, including deviations, CAPA, change control, and document management.
- Excellent analytical, problem-solving, and decision-making skills with a keen eye for detail.
- Exceptional written and verbal communication skills, with the ability to influence and collaborate effectively across all levels.
- ASQ Certification (e.g., CQE, CQA) is a plus.