Sr Manager Quality Control

About the role

The Senior Manager, Quality Control (QC) is a strategic, multi‑site people leader accountable for the compliant, reliable, and efficient operation of QC testing laboratories supporting biotherapeutic and advanced therapy programs at Johnson & Johnson’s Malvern and Spring House locations in Pennsylvania. This role is a member of the Site Quality Leadership Team, reports to the Site Quality Head, and leads an organization of 80+ full‑time employees and contractors.

Key Responsibilities

• People Leadership & Strategy
  • Lead, develop, and retain a multi‑site QC organization of 80+ staff, including managers, supervisors, analysts, and support roles.
  • Set QC vision, organization design, operating model, goals, performance expectations, succession plans, and workforce strategy for both sites.
  • Oversee talent acquisition, performance management, development, recognition, compensation recommendations, promotions, employee relations, organizational design, and corrective actions in partnership with Human Resources.
  • Build a culture of quality, safety, accountability, inclusion, technical excellence, collaboration, and continuous improvement.
• Multi‑Site QC Laboratory Oversight
  • Provide integrated oversight of QC testing laboratories supporting biotherapeutics and advanced therapies, including cell and gene therapy programs.
  • Ensure accurate and timely sampling, testing, review, approval, and reporting for raw and incoming materials, in‑process samples, drug substance, drug product, release, stability, environmental and utility monitoring, validation studies, reagents, media, and buffers.
  • Oversee sample management, reference standards, critical reagents, laboratory inventory, and the qualification, calibration, maintenance, and lifecycle management of QC equipment.
  • Manage the lifecycle of diverse analytical platforms and assays (identity, purity, potency, safety, microbiological, molecular, cell‑based, and compendial methods) with appropriate controls for complex, time‑sensitive advanced therapy products.
  • 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.
• Compliance, Data Integrity & Laboratory Performance
  • Maintain laboratory compliance with applicable cGMP requirements, global quality standards, approved procedures, data integrity principles, and health, safety, and environmental expectations.
  • Govern and close non‑conformance investigations, invalid assays, out‑of‑specification/out‑of‑trend results, laboratory investigations, CAPAs, change controls, method transfers, qualifications, and validations.
  • Maintain validated, reliable, and inspection‑ready computerized laboratory systems (e.g., eLIMS, Empower) for sample, instrument, method, and data management.
  • Provide accurate QC data and trend analyses for annual product reviews, quarterly management reviews, CPV, 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 deviates.
• Technical Strategy, Business Partnership & Inspection Readiness
  • Define and execute multi‑site QC strategy covering laboratory capacity, headcount, 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 technology 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 risks appropriately.
  • Serve as senior QC representative during health‑authority inspections, internal audits, governance forums, and escalations; maintain sustained inspection readiness and ensure commitments are completed on time.

Qualifications & Experience

• Bachelor’s degree in biology, biochemistry, microbiology, chemistry, biotechnology, engineering, or a related scientific discipline (advanced degree preferred).
• Minimum 10 years of progressive experience in the pharmaceutical, biotechnology, or biopharmaceutical industry, with substantial experience in GMP Quality Control laboratories.
• At least five years of direct people‑management experience, leading large, complex organizations (80+ employees/contractors preferred).
• Strong experience supporting biologics or biotherapeutics; direct experience with advanced therapies, especially cell and gene therapy testing, is strongly preferred.
• Broad knowledge of analytical and microbiological laboratory operations, method lifecycle activities, investigations, data review, statistical trending, electronic laboratory systems, sample management, and equipment lifecycle management.
• Working knowledge of 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 regulated environment.

Key Competencies

• Enterprise People Leadership – builds leadership depth, develops technical talent, sets clear accountability, and engages a large, diverse workforce across two sites.
• QC Technical Acumen – applies strong scientific and laboratory knowledge to biologics and cell‑ and gene‑therapy testing strategies, risks, and decisions.
• Quality & Compliance Leadership – maintains high standards for cGMP compliance, data integrity, documentation, investigation quality, and inspection readiness.
• Strategic & Operational Excellence – translates portfolio and supply needs into practical capacity, resource, technology, and improvement plans.
• Risk‑Based Decision‑Making – integrates science, compliance, product knowledge, and business context to resolve complex issues and escalate appropriately.
• Collaboration & Influence – aligns stakeholders across sites and functions and communicates complex topics clearly to technical, quality, and senior leadership audiences.

Leadership Expectations

• Model visible, inclusive, and accountable leadership across Malvern and Spring House.
• Ensure patient safety, product quality, compliance, and employee safety remain central to all decisions.
• Set clear priorities, remove barriers, and hold leaders and teams accountable for sustainable results.
• Develop successors, strengthen technical capability, and provide timely 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.

Travel & Working Conditions

This role requires periodic travel between the Malvern and Spring House sites and may involve approximately 10–20 % domestic or international travel. The incumbent must be able to work in laboratory and manufacturing environments and comply with gowning, personal protective equipment, health, safety, and site‑access requirements.