Director, Manufacturing Quality and Regulatory Affairs

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Full-time Regular Remote, 0, 0, US

Salary: $ Annually

Pharma Logic is the fastest-growing SPECT & PET radiopharmaceutical solutions provider and contract development and manufacturing organization (CDMO) with radio pharmacies across North America. We are passionate about expanding the power of radiopharmaceutical technology to provide transformative diagnostic and therapeutic agents to patients from bench to bedside.

• 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…