Sr. QA Specialist, Supplier Quality

The Sr. QA Specialist – Supplier Quality leads the qualification and ongoing quality oversight of third parties, including suppliers, service providers, and contract development and manufacturing organizations (CDMOs), and supports key quality system functions to ensure compliance with cGMP and regulatory standards in a biotech environment. With over five years of experience, this role manages complex investigations, oversees change control and CAPA processes, supports regulatory inspections, and mentors junior QA staff.

The specialist drives continuous improvement and cross-functional collaboration to uphold product quality and operational excellence.

• Lead risk-based qualification and requalification of third parties, including suppliers and service providers, through assessments, audits, and documented recommendations for approval.
• Manage ongoing third-party quality oversight, including performance monitoring, quality agreements, change notifications, and follow-up on quality issues and corrective actions.
• Maintain third-party qualification records and approved status, ensuring timely periodic reviews and escalation of quality and compliance risks.
• Manage contractors and consultants performing third‑party audits, including audit scope, scheduling, and deliverable review; independently plan and conduct audits, prepare reports, and follow up on corrective actions.

• Lead and execute quality oversight of manufacturing and QC operations, including executed batch record review, deviations, investigations, risk assessments, change control, SOPs and cross‑functional liaison to ensure compliance with cGMP and internal quality standards.
• Independently lead quality‑driven projects and present key quality metrics, training initiatives, and validation documentation reviews to leadership and cross‑functional teams.
• Drive ownership of quality systems, including change control, CAPA, and document management, with accountability for process improvement and regulatory alignment.
• Author, review, and approve controlled documentation, including SOPs, batch records, and work instructions, ensuring accuracy, completeness, and adherence to applicable regulatory standards.
• Perform batch disposition activities by reviewing batch records, in‑process and release testing results, environmental monitoring records, Certificates of Analysis (CoAs), deviation investigations, and quality event closures to determine and document batch approval or rejection decisions.
• Inspect and approve raw materials, packaging components, and in‑process materials against approved specifications and/or CoAs, ensuring compliance with internal standards, regulatory expectations, and release criteria prior to use in manufacturing operations.
• Provide QA floor support during manufacturing process as needed
• Other duties/responsibilities as assigned.

This position does not have supervisory responsibilities. Mentors junior QA staff as needed.

• BS/BA in life sciences
• 5+ years of quality assurance experience in a regulated manufacturing environment required (FDA, EMA, MHRA, Health Canada). Pharmaceutical or related industry experience is highly preferred.
• Hands‑on experience qualifying, auditing, and overseeing GMP suppliers and service providers required, including risk assessments, quality agreements, and corrective‑action follow‑up.
• Experience qualifying and overseeing GLP and GCP service providers, including nonclinical laboratories and clinical research organizations, preferred.
• Must have strong communication skills. Demonstrated proficiency in Microsoft Office software (Word, Excel, PowerPoint and Outlook).
• Ability to effectively present information in one‑on‑one, small…