Director, Quality Management - Sterile Operations

Description:

The Director, Quality Management - Sterile Manufacturing serves as the senior Quality representative responsible for providing end-to-end Quality leadership for sterile manufacturing expansion, from concept, design, construction, and commissioning through qualification, process validation, regulatory readiness, commercial launch, and routine GMP manufacturing operations.

This role provides independent Quality oversight and decision-making across Terminal Sterilization (TS), Blow-Fill-Seal (BFS), Pre-Filled Syringe (PFS), and IV Bag manufacturing, including both terminally sterilized and aseptically processed operations.

The Director ensures that facilities, utilities, equipment, computerized systems, processes, contamination control strategies, laboratories, documentation, and operating practices are designed, qualified, operated, and maintained in compliance with applicable FDA regulations, EU GMP requirements (including Annex 1), ICH guidance, USP standards, company policies, and the approved regulatory strategy.

The position partners closely with Engineering, Validation, Manufacturing, MS&T, Microbiology, Quality Control, Regulatory Affairs, Supply Chain, EHS, and project leadership to support successful project execution and operational excellence, while maintaining the appropriate level of Quality independence and authority for GMP decision-making, risk assessment and acceptance, release readiness, and quality-related escalation.

Essential Functions:

• Provide independent Quality oversight and approval of the commissioning and qualification lifecycle, including URS, design qualification, FAT/SAT strategy, commissioning turnover, IQ/OQ/PQ, qualification deviations, traceability, and final reports for facilities, utilities, equipment, laboratories, and critical computerized systems.

• Provide Quality oversight for the qualification and validation of critical utilities and systems, including HVAC, WFI, purified water, clean steam, compressed gases, sterilizers/autoclaves, depyrogenation systems, filling equipment, BFS systems, PFS lines, IV Bag lines, CIP/SIP systems, isolators/RABS, environmental monitoring systems, and cold chain/storage systems, as applicable.

• Lead Quality governance for aseptic process simulations (media fills), sterilization cycle development and validation, depyrogenation validation, container closure integrity testing, cleaning validation, hold-time studies, shipping qualification, filter validation, and other critical validation programs required for commercial readiness.

• Ensure the Pharmaceutical Quality System is operational before GMP start-up, including procedures, document control, training, deviation/OOS/OOT management, CAPA, change control, risk management, supplier quality, complaint management, APR/PQR, batch record control, audit trail review, data governance, and management review processes.

• Approve GMP readiness of Manufacturing, QC, and Microbiology operations, including laboratories, methods, specifications, sampling plans, environmental and utility monitoring programs, sterility assurance controls, microbiological identification strategies, environmental monitoring qualification, gowning qualification, and personnel aseptic qualification.

• Provide Quality oversight for engineering, process development, exhibit and registration batches, PPQ, and commercial manufacturing batches. Ensure deviations are scientifically investigated, critical process parameters and quality attributes are controlled, batch records are complete, and disposition decisions are supported by documented evidence and approved procedures.

• Lead inspection and regulatory readiness activities for the new sterile manufacturing operation. Support regulatory submissions, pre-approval inspections, and health authority inspections, ensuring commitments, responses, CAPAs, and inspection observations are addressed with technically sound and sustainable corrective actions.

• Build and develop the Sterile Quality organization, including role definition, staffing plans, technical competency requirements, qualification curricula, succession planning, and routine performance governance. Establish a strong Quality culture that emphasizes right-first-time execution, timely escalation, and science- and risk-based decision-making.

• Following commercial launch, maintain Quality oversight of routine sterile manufacturing operations, including continued process verification, sterility assurance, environmental and utility trend monitoring, deviation management, CAPA effectiveness, change control, periodic reviews, Product Quality Reviews (PQRs), inspection readiness, and continuous improvement to sustain a state of control.

Additional Responsibilities:

• Manage daily performance of staff.

• Ensures projects, goals and deadlines are being met.

• Adhere to all budget requirements. Maintain high-level of confidentiality, in regard to Company and employee information.

• Additional responsibilities as assigned.