Senior Quality Assurance Manager

Responsibilities:

• Lead and develop Quality Assurance Operations teams supporting formulation and aseptic filling activities.
• Provide quality oversight for aseptic manufacturing processes, sterility assurance, and contamination control strategies.
• Maintain strong on-the-floor QA presence to support manufacturing operations and ensure compliance with GMP standards.
• Lead and support room clearance, line clearance, and contamination control activities within manufacturing areas.
• Train and mentor QA personnel on aseptic behaviors, gowning practices, contamination control principles, and quality systems.
• Partner with Operations teams to support batch record review, real-time quality oversight, and deviation response activities.
• Lead investigation activities utilizing root cause analysis and risk assessment methodologies to support corrective and preventive actions.
• Support regulatory inspections, customer audits, and internal audit readiness initiatives.
• Collaborate cross-functionally to maintain operational compliance, product quality, and continuous improvement initiatives.
• Utilize electronic systems including eQMS, SCADA, LIMS, CMMS, and related manufacturing systems to ensure documentation accuracy and data integrity compliance.
• Support implementation and continuous improvement of SOPs, quality processes, and manufacturing procedures.

Qualifications:

• Bachelor’s degree required; scientific discipline preferred (Biology, Chemistry, Microbiology, or related field).
• Minimum 5 years of Quality Assurance experience within biopharmaceutical, pharmaceutical, or similarly regulated manufacturing environments.
• Strong knowledge of aseptic manufacturing, sterility assurance, contamination controls, and GMP quality systems.
• Experience supporting risk-based decision making related to product quality and manufacturing deviations.
• Working knowledge of FDA, EMA, and global regulatory expectations for pharmaceutical manufacturing operations and Quality systems.
• Experience with manufacturing systems and data analysis tools including SCADA, Excel, JMP, Minitab, Visio, or similar platforms.
• Strong leadership, coaching, communication, and cross-functional collaboration skills.