Senior Quality Assurance Specialist (CMC)

What You'll Do

The Senior Quality Assurance Specialist provides quality assurance oversight across CMC development, Quality Control, Analytical Development, manufacturing, and supply chain activities, ensuring compliance with global regulatory requirements and internal quality standards. In this role, you serve as a subject matter expert in GMP quality systems, CMC quality oversight, and regulatory inspection readiness while supporting the successful advancement of development and commercial programs.

The Senior Quality Assurance Specialist provides quality assurance oversight across CMC development, Quality Control, Analytical Development, manufacturing, and supply chain activities, ensuring compliance with global regulatory requirements and internal quality standards. In this role, you serve as a subject matter expert in GMP quality systems, CMC quality oversight, and regulatory inspection readiness while supporting the successful advancement of development and commercial programs.

• Provide quality oversight for GMP manufacturing activities across drug substance and drug product operations, including external manufacturing partners and CDMOs.
• Review and approve GMP documentation, including batch records, SOPs, protocols, validation reports, stability reports, investigations, and other quality records to ensure compliance with applicable regulations and company requirements.
• Support batch disposition activities and ensure products are manufactured, tested, and released in accordance with cGMP requirements.
• Partner with CMC, Technical Operations, and cross-functional teams to support technology transfer, process scale-up, process validation, and manufacturing readiness activities.
• Ensure timely initiation, investigation, closure, and effectiveness monitoring of deviations, CAPAs, and change controls.
• Identify and communicate quality risks while partnering with stakeholders to implement practical and compliant mitigation strategies.
• Support implementation, maintenance, and continuous improvement of Quality Management System (QMS) processes, including deviations, CAPA, change control, document control, training, and quality risk management.
• Assess quality systems and processes against FDA, EMA, ICH, and other applicable regulatory expectations and drive inspection-ready improvements.
• Develop, revise, and maintain quality procedures and standard operating procedures that support compliance while enabling efficient business operations.
• Support internal audits, supplier audits, and CDMO audits to assess compliance and identify opportunities for continuous improvement.
• Drive inspection readiness activities through gap assessments, mock inspections, documentation reviews, and focused remediation efforts.
• Draft, review, and support responses to audit observations, supplier findings, and regulatory inspection outcomes.
• Maintain consistency, traceability, and integrity across quality systems, documentation, and GMP records.
• Perform other duties and projects as assigned.

This position operates in a dynamic and highly regulated pharmaceutical environment where effective quality oversight is critical to product quality, patient safety, regulatory compliance, and business success. The role requires sound judgment, strong analytical skills, and the ability to balance compliance requirements with operational objectives. Success requires the ability to independently evaluate complex quality issues, collaborate effectively across multiple functions and external partners, and drive practical solutions that maintain regulatory compliance while supporting program execution.

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, Engineering, or a related scientific discipline; advanced degree preferred.
• Minimum of 5 years of Quality Assurance experience within the biotechnology or pharmaceutical industry operating under GMP regulations.
• Strong working knowledge of FDA and EMA cGMP regulations and applicable ICH guidelines, including Q7, Q8, Q9, and Q10.
• Experience supporting pharmaceutical manufacturing operations and providing quality oversight of suppliers, contract manufacturers, and CDMOs.
• Experience reviewing and approving GMP documentation, investigations, deviations, CAPAs, change controls, and validation-related documentation.
• Working knowledge of Quality Management Systems and regulatory inspection readiness practices.
• Strong written and verbal communication skills with the ability to effectively collaborate across functional teams and external partners.

• Advanced degree in a scientific, engineering, or related discipline.
• Experience supporting CMC development activities, analytical development programs, and technology transfer initiatives.
• Thorough understanding of pharmaceutical and medical device Quality Management Systems.
• Experience supporting regulatory inspections and responding to audit observations and regulatory findings.
• Knowledge of process…