Quality Director Jobs

About The Position

Requirements

• Bachelor’s degree in biology, biochemistry, microbiology, chemistry, biotechnology, engineering, or a related scientific discipline.
• At least 10 years of relevant, progressive experience in the pharmaceutical, biotechnology, or biopharmaceutical industry, including substantial experience in GMP Quality Control laboratories.
• At least five years of direct people-management experience, with demonstrated success leading large, complex organizations through multiple layers of leadership.
• Broad knowledge of analytical and microbiological laboratory operations, analytical method lifecycle activities, laboratory investigations, data review, statistical trending, electronic laboratory systems, sample management, and equipment lifecycle management.
• Strong working knowledge of applicable FDA, EMA, ICH, pharmacopeial, and global cGMP expectations for biologics and advanced therapy products.
• Proven success managing multi-site operations, operating and capital budgets, laboratory capacity, competing priorities, organizational change, and complex cross-functional initiatives.
• Excellent judgment, communication, influence, problem-solving, and stakeholder-management skills, with the ability to make timely, risk-based decisions in a complex regulated environment.
• Ability to work in laboratory and manufacturing environments and comply with applicable gowning, personal protective equipment, health, safety, and site-access requirements.
• Periodic travel between Malvern and Spring House is required; the role may require approximately 10–20% domestic or international travel.

Nice To Haves

• An advanced degree.
• Experience with organizations comparable to 80+ employees and contractors.
• Strong experience supporting biologics or biotherapeutics.
• Direct experience with advanced therapies, particularly cell and gene therapy testing.

Responsibilities

• Lead, develop, and retain a multi-site QC organization of 80+ full-time employees and contractors, including managers, supervisors, analysts, and support roles.
• Set the QC vision, organization design, operating model, goals, performance expectations, succession plans, and workforce strategy for Malvern and Spring House.
• Exercise leadership authority for talent acquisition, performance management, development, recognition, compensation recommendations, promotions, employee relations, organizational design, and appropriate corrective actions in partnership with Human Resources.
• Build a culture of quality, safety, accountability, inclusion, technical excellence, collaboration, and continuous improvement.
• Provide integrated oversight of QC testing laboratories supporting biotherapeutics and advanced therapies, including cell and gene therapy programs, across both sites.
• Ensure accurate and timely sampling, testing, review, approval, and reporting for applicable materials, samples, products, monitoring, studies, reagents, media, and buffers.
• Oversee sample management, reference standards, critical reagents, laboratory inventory, and qualification, calibration, maintenance, and lifecycle management of QC equipment.
• Oversee the lifecycle of analytical platforms and assays, including identity, purity, potency, safety, microbiological, molecular, cell-based, and compendial methods.
• Ensure effective execution of method development support, qualification, validation, transfer, and verification activities, as well as QC support for Process Performance Qualification, Continued Process Verification, and product comparability.
• Maintain laboratory compliance with applicable cGMP requirements, global quality standards, approved procedures, data integrity principles, and health, safety, and environmental expectations.
• Ensure robust governance and timely closure of nonconformance investigations, invalid assays, out-of-specification and out-of-trend results, laboratory investigations, CAPAs, change controls, method transfers, qualifications, and validations.
• Maintain validated, reliable, and inspection-ready computerized laboratory systems, including eLIMS, Empower, and other systems used for sample, instrument, method, and data management.
• Provide accurate QC data and trend analyses for annual product reviews, quarterly management reviews, Continued Process Verification, investigations, regulatory submissions, and product quality complaint assessments.
• Establish and monitor metrics for testing delivery, right-first-time performance, backlog, cycle time, capacity, compliance, and reliability; lead recovery and risk-mitigation plans when performance is off target.
• Define and execute the multi-site QC strategy, including laboratory capacity, headcount and contractor planning, scheduling, asset and facility needs, digital laboratory systems, automation, operating budgets, and strategic capital projects.
• Partner with Manufacturing, Quality Assurance, Analytical Development, Technical Operations, Supply Chain, Regulatory, Procurement, and external testing laboratories to support transfers, product introductions, supplier material qualification, reduced-testing programs, comparability, investigations, release, and supply continuity.
• Make timely, risk-based decisions within delegated authority for staffing, laboratory priorities, resource allocation, budgets, external testing, quality events, and operational recovery; escalate significant quality, compliance, safety, or supply risks appropriately.
• Serve as the senior QC representative during health authority inspections, internal audits, governance forums, and escalations; maintain sustained inspection readiness and ensure commitments are completed effectively and on time.
• Model visible, inclusive, and accountable leadership across both sites; keep patient safety, product quality, compliance, and employee safety central to decisions.
• Set clear priorities, remove barriers, hold leaders and teams accountable for sustainable results, develop successors, strengthen technical capability, and provide coaching and performance feedback.
• Champion science- and risk-based improvement, digital enablement, standardization, and collaboration while upholding J&J Credo values and respect for people.