US Site Quality Lead

Key Responsibilities and Duties

Quality Leadership & Strategy

• Serve as the senior Quality leader and member of the Site Leadership Team, contributing to site strategy, business planning, organizational development, and operational decision-making.
• Establish and execute the site Quality strategy, objectives, priorities, and roadmap aligned with corporate quality and business goals.
• Lead, develop, and mentor QA and QC teams, building a culture of quality, accountability, scientific rigor, continuous improvement, and employee engagement.
• Maintain the independence, authority, and integrity of the Quality organization in GMP decision-making.

Quality Management System (QMS)

• Ensure the development, implementation, maintenance, and continuous improvement of an effective, risk-based QMS appropriate for a Phase 3 and commercial manufacturing environment.
• Oversee core quality systems including deviations, CAPA, change control, investigations, complaints, risk management, supplier quality, document control, training, and management review.
• Lead Quality Review Boards, Change Control Boards, CAPA governance, and Management Review processes.
• Establish and monitor site quality metrics, quality plans, and performance indicators to identify trends, manage risk, and drive improvement.

GMP Operations & Product Quality

• Provide independent Quality oversight of the manufacture, testing, release, storage, and distribution of radiopharmaceutical products.
• Ensure effective systems for raw material, component, intermediate, finished product, and batch record review and disposition.
• Establish appropriate Quality oversight and release processes for clinical and commercial products.
• Review and approve GMP documentation, including procedures, specifications, investigations, change controls, validation protocols and reports, and quality agreements.
• Ensure product quality decisions are based on sound science, applicable regulations, approved procedures, and product specifications.

Quality Control Oversight

• Lead and oversee QC laboratory operations, including analytical testing, sampling, environmental monitoring, stability, and laboratory investigations.
• Ensure analytical methods, specifications, laboratory systems, equipment, and computerized systems are appropriately qualified, validated, and maintained.
• Ensure laboratory data integrity and timely, scientifically sound review and reporting of analytical results.
• Partner with MSAT, Manufacturing, and R&D to resolve analytical and product quality issues.

Validation, Qualification & Technical Quality

• Provide Quality oversight of the qualification and validation of facilities, utilities, equipment, processes, analytical methods, and computerized systems.
• Ensure appropriate Quality involvement in commissioning, qualification, technology transfer, process validation, and process lifecycle management.
• Support facility expansion, process scale-up, technology transfer, and commercialization readiness through risk-based Quality strategies.
• Drive quality improvement initiatives and implementation of risk-based approaches to quality management.

Supplier & External Partner Quality

• Establish and maintain appropriate Quality oversight of suppliers, contract manufacturers, testing laboratories, logistics providers, and other critical external partners.
• Ensure appropriate qualification, quality agreements, performance monitoring, audits, and risk management for critical suppliers and service providers.
• Partner with Supply Chain and Technical Operations to address supplier quality risks and ensure continuity of compliant supply.

Regulatory Compliance & Inspection Readiness

• Ensure ongoing compliance with applicable cGMP, FDA, ICH, PIC/S, radiation safety, and other relevant regulatory requirements.
• Establish and maintain continuous inspection readiness for FDA and other regulatory inspections, customer audits, and corporate quality audits.
• Lead site Quality participation in regulatory inspections and ensure timely, effective responses to observations, commitments, and quality findings.
• Serve as the site's senior Quality representative during regulatory interactions and inspections.

Quality Culture, Safety & Compliance

• Foster a strong culture of quality, patient focus, safety, integrity, accountability, and continuous improvement across the site.
• Ensure Quality personnel maintain appropriate training, qualifications, and technical competencies.
• Partner with HSE/Radiation Safety to ensure appropriate Quality oversight of activities involving radioactive materials and applicable radiation safety, environmental, and transport requirements.
• Promote proactive identification and escalation of quality and compliance risks.

Resource & Financial Management

• Develop and manage Quality staffing plans, budgets, external resources, and organizational capabilities to support Phase 3 and future commercial operations.
• Recruit, develop, and retain high-performing Quality professionals and establish effective succession planning.
• Scale the Quality organization, systems, and capabilities in line with the evolving needs of the Andover site and broader AdvanCell network.

Essential Skills, Responsibilities, Industry and Educational Requirements

Bachelor's degree in Pharmacy, Chemistry, Biochemistry, Microbiology, Engineering, Life Sciences, or a related scientific discipline.
12+ years of progressive experience in pharmaceutical, biotechnology, radiopharmaceutical, biologics, sterile manufacturing, or related regulated industries.
7+ years of leadership experience managing Quality Assurance, Quality Control, or site quality organizations.
Demonstrated experience leading and maintaining GMP Quality Management Systems within regulated manufacturing environments.
Strong knowledge of global GMP regulations and quality standards, including TGA, FDA, EMA, PIC/S, ICH, and applicable quality system requirements.
Experience leading regulatory inspections, including preparation, hosting, response management, and closure of observations.
Proven experience managing deviations, CAPAs, change controls, validation programs, investigations, and batch disposition activities.
Strong leadership, communication, stakeholder management, and decision-making skills.
Ability to influence across functions and levels of the organization while maintaining quality independence.
Demonstrated ability to build high-performing teams and develop technical and leadership capability.
Strong analytical, problem-solving, and risk management skills.  

Desired Skills, Responsibilities, Industry and Educational Requirements

Advanced degree (MSc, PhD, PharmD, or equivalent) in a scientific, engineering, or related discipline.
Experience in just-in-time radiopharmaceutical manufacturing, nuclear medicine, radiochemistry, or radioactive materials management.
Experience supporting clinical-stage products through commercialization and regulatory approval.
Knowledge of radiation safety requirements and regulations applicable to radiopharmaceutical manufacturing and distribution.
Experience with aseptic processing, sterile manufacturing, and/or highly potent compounds.
Experience supporting technology transfers, facility start-up, commissioning, qualification, and validation activities.
Familiarity with computerized quality systems, electronic batch records, LIMS, ERP, and data integrity requirements.
Certification in Quality Management, Lean Six Sigma, Operational Excellence, or related disciplines.
Experience establishing and scaling quality organizations within rapidly growing or emerging biotechnology companies.