Senior QA Specialist

Job Title: Senior QA Specialist

Location: New York, NY

Duration: 12+ Months

Job Summary:

We are seeking an experienced Senior Quality Assurance Specialist with strong pharmaceutical or biotechnology industry experience to support Quality and Compliance activities within a highly regulated GMP environment. The ideal candidate will have extensive hands-on experience with pharmaceutical quality systems, investigations, CAPA, change control, risk management, and regulatory compliance.

Key Responsibilities:

• Provide senior-level QA oversight for GMP manufacturing and quality operations.
• Review and support deviations, investigations, CAPAs, change controls, and quality risk assessments.
• Ensure compliance with FDA, EU GMP, cGMP, and applicable regulatory requirements.
• Support quality systems, validation activities, controlled documentation, and data integrity initiatives.
• Participate in internal audits, regulatory inspections, and inspection-readiness activities.
• Partner with Manufacturing, QC, Validation, Engineering, and other cross-functional teams to identify and resolve quality issues.
• Provide QA guidance and serve as a Quality SME on GMP and compliance-related matters.
• Review and approve quality documentation in accordance with established procedures and regulatory requirements.
• Identify compliance gaps and support continuous improvement of quality processes and systems.
• Promote a strong culture of quality and compliance across cross-functional teams.

Required Qualifications:

• 8 10+ years of hands-on Quality Assurance experience within pharmaceutical, biotechnology, or a similarly regulated industry.
• Strong knowledge of GMP/cGMP requirements and pharmaceutical quality systems.
• Proven experience with deviations, investigations, CAPA, change controls, risk management, and audits.
• Strong understanding of data integrity, documentation practices, and regulatory compliance.
• Experience supporting FDA and/or international regulatory inspections preferred.
• Bachelor's degree in Life Sciences, Chemistry, Engineering, Pharmacy, or a related scientific discipline preferred.
• Strong communication, technical writing, problem-solving, and cross-functional collaboration skills.
• Ability to work independently, prioritize multiple quality activities, and provide effective QA guidance in a fast-paced GMP environment.