Role: Director, 211 Manufacturing Quality and RegulatoryReports to: VP, Quality and RegulatoryStarting Salary - &190,000+ (Bonus Eligible)Remote Position - West Coast and Rocky Mountain Region PreferredThe Director, 211 Manufacturing Quality & Regulatory Affairs is responsible for providing enterprise Quality and Regulatory governance for U.S. operations, facilities, projects, and client programs subject to 21 CFR Parts 210 and 211.
The Director provides Quality Unit leadership and oversight of the Quality Management System, regulatory compliance, inspection readiness, quality risk management, and continuous improvement activities supporting the development, technology transfer, manufacturing, testing, and release of therapeutic radiopharmaceutical products. This position serves as a subject matter expert in pharmaceuticals, ensuring compliance with FDA regulations, current Good Manufacturing Practices (cGMP), USP standards and all applicable federal and state regulations. The Director partners closely with internal and external stakeholders to ensure product quality, regulatory compliance, operational excellence, and client satisfaction.
Essential Duties & Responsibilities
• Provide Quality and Regulatory governance for all US facilities, projects, technology transfers, client programs, and manufacturing activities operating under 21 CFR Parts 210 and 211. Serve as the primary Quality and Regulatory point of contact for all 211 facilities, providing leadership, guidance, escalation support, and consistent application of cGMP requirements and company quality standards across sites.
• Lead and maintain the Quality Management System (QMS) in compliance with FDA cGMP requirements, applicable USP standards, ICH guidelines, and applicable federal and state regulations, including oversight of deviations, investigations, CAPA, change control, OOS/OOT, complaints, document control, training, supplier quality, audits, and product quality review.
• Provide Quality Unit leadership and authority consistent with 21 CFR Part 211 requirements, including escalation of significant quality and compliance risks and appropriate authority to prevent or stop GMP activities when product quality, patient safety, date integrity, or regulatory compliance may be compromised.
• Establish Quality governance and readiness criteria for new and existing 211 operations, including facility startups and expansions, new client programs, technology transfers, equipment and facility qualification, process and cleaning validation, analytical method transfer/validation, and computerized systems.
• Maintain continuous regulatory and inspection readiness across all applicable 211 facilities and serve as the primary organizational point of contact for Quality and Regulatory matters related to 211 facilities, including serving as the lead Quality representative and FDA point of contact during regulatory inspections and interactions.
• Lead regulatory inspections and audit response activities, including response to FDA Form 483 observations, client audit findings, regulatory correspondence, and significant compliance concerns, ensuring effective root cause analysis, remediation, CAPA implementation, and verification of effectiveness.
• Monitor evolving regulatory requirements ad industry expectations, including FDA regulations and guidance, USP standards, ICH guidelines, enforcements trends, and applicable federal and state requirements, and translate changes into appropriate Quality System and operational improvements
• Provide Quality and Regulatory oversight of GMP manufacturing and product lifecycle activities, including manufacturing, laboratory operations, validation, batch record review, product disposition, data integrity, and oversight of suppliers, contract laboratories, and other GMP service providers.
• Serve as the senior Quality and Regulatory partner for CDMO clients, providing guidance and escalation support for manufacturing processes, technology transfers, validation strategies, investigations, product quality issues, regulatory submissions and requests, inspections, and other GMP compliance matters.
• Lead Quality Agreement development and governance with client sponsors and key GMP Service providers, ensuring responsibilities, regulatory commitments, escalation pathways, and quality expectations are clearly defined and maintained.
• Establish and lead Quality Management Review and continuous improvement activities, including development and trending of key quality indicators, identification of systemic risks and recurring issues, quality risk management, and implementation of cross-functional improvement initiatives.
• Build, develop, and mentor high-performing Quality and Regulatory teams while promoting consistent Quality standards and a culture of quality, accountability, regulatory compliance, data integrity, operational excellence, and continuous improvement across US operations.
Required Qualifications
• Bachelor's degree in Pharmacy, Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Engineering, or related scientific discipline required.
• Advanced degree preferred (MS, PharmD, or PhD).
• Minimum 10 years of progressive experience in pharmaceutical, biotechnology, radiopharmaceutical, or therapeutic manufacturing environments.
• Minimum 5 years of quality leadership experience.
• Experience within a CDMO, pharmaceutical manufacturer, biotechnology company, or regulated healthcare manufacturing environment in a 211 environment.
• Proven technical knowledge of FDA cGMP regulations, 21 CFR Parts 210 and 211
• Demonstrated success leading FDA inspections and regulatory interactions.
• Experience implementing and maintaining robust Quality Management Systems.
• Multi-site quality oversight
• Startup or rapid-growth manufacturing environments
Come join our winning team and begin a fulfilling career with us by applying today.
Benefits Include: 401(k) retirement benefit program
- Medical
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Life insurance
- Paid time off
- Vision care
