Director of Quality Control

Position SummaryThe Director of Quality Control provides strategic and operational leadership for the Quality Control function, including chemical, microbiological, raw-material, in-process, finished-product, environmental-monitoring, and stability testing, as applicable. This leader ensures that laboratory operations, data, methods, specifications, and release-support activities comply with current Good Manufacturing Practice requirements, approved procedures, regulatory commitments, and the company’s pharmaceutical quality system. The Director develops laboratory capability, promotes data integrity and scientific rigor, and partners across the organization to ensure the consistent delivery of safe, effective, and high-quality products.Essential Duties and ResponsibilitiesSet the vision, priorities, operating model, and annual objectives for Quality Control in alignment with site and enterprise quality strategies.Lead day-to-day QC laboratory operations and ensure timely, accurate testing of raw materials, components, in-process materials, finished products, stability samples, utilities, and environmental samples, as applicable.Ensure laboratory controls, specifications, sampling plans, test methods, documentation, and records meet cGMP requirements and applicable FDA, Health Canada, and internal standards.Maintain a strong culture of data integrity, right-first-time execution, scientific judgment, safety, accountability, and continuous improvement.Oversee method development, transfer, qualification, validation, verification, and lifecycle maintenance in partnership with Process Development and other technical functions.Provide governance for laboratory investigations, including out-of-specification, out-of-trend, atypical, invalid, and deviation events; ensure investigations are timely, scientifically sound, and supported by effective CAPA.Monitor stability programs, reference standards, retain samples, laboratory instrumentation, computerized systems, reagents, standards, and sample-management processes.Establish and review key performance indicators for quality, compliance, service, capacity, cost, and personnel; identify trends and implement sustainable corrective or preventive actions.Ensure the QC function is inspection-ready; host or support regulatory inspections, customer audits, internal audits, and responses to observations or commitments.Develop resource, succession, workforce, capital, and operating plans; manage the QC budget and balance laboratory capacity with business demand.Select, qualify, and oversee contract laboratories, suppliers, and service providers in collaboration with Quality Assurance and Procurement.Recruit, coach, and retain a high-performing team; establish clear expectations, assess performance, build technical and leadership capability, and ensure required training is completed and effective.Partner cross functionally to support product release, investigations, change controls, technology transfers, process validation, and new-product introductions.Serve as a senior subject-matter expert for laboratory controls and escalate significant quality or compliance risks to site leadership.Perform other duties consistent with the scope and level of the position.Required QualificationsBachelor’s degree in chemistry, biochemistry, microbiology, pharmaceutical sciences, or a related scientific discipline. Masters preferred.At least 10 years of progressively responsible experience in pharmaceutical, biotechnology, biologics, or another highly regulated laboratory environment.At least 5 years of direct people-leadership experience, including responsibility for managers or multiple laboratory teams.Demonstrated knowledge of cGMP laboratory controls, data integrity, analytical methods, stability programs, investigations, CAPA, change control, and inspection readiness.Experience with sterile, aseptic, allergenic, biologic, or combination-product operations, as relevant to the site portfolio.Experience with laboratory information management systems, chromatography data systems, electronic quality systems, and computerized-system validation.Quality, operational-excellence, or project-management certification, such as ASQ, Lean Six Sigma, or PMP.Experience interacting with health authorities and leading or supporting regulatory inspections.Strong record of applying scientific and risk-based decision-making to complex laboratory and product-quality issues.Excellent written, verbal, organizational, and cross-functional leadership skills.Leadership CompetenciesBuild trust through integrity, transparency, sound judgment, and consistent follow-through.Sets clear direction, translates strategy into execution, and holds teams accountable for measurable results.Develop people through coaching, candid feedback, empowerment, and meaningful growth opportunities.Challenges the status quo while protecting product quality, patient safety, and regulatory compliance.