Senior Manager – Quality Control

Johnson & Johnson

. Lead and develop a multi-site QC organization of 80+ full-time employees and contractors across Malvern and Spring House .

Posted 9/18/2026full-timeMalvern • Pennsylvania • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in leading multi-site Quality Control operations, ensuring compliance with cGMP and global quality standards while managing complex laboratory environments. Proficient in analytical method lifecycle management, data integrity, and risk-based decision-making in the biopharmaceutical industry.

Highest-signal resume keywords

GMP Quality ControlBiotherapeutics ExperienceAnalytical Method Lifecycle ManagementMulti-Site Operations ManagementRegulatory Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Analytical PlatformsMicrobiological MethodsLaboratory InvestigationsData ReviewStatistical TrendingSample ManagementEquipment Lifecycle ManagementMethod DevelopmentProcess Performance QualificationValidation Studies

Soft Skills

LeadershipDecision-MakingCollaborationRisk ManagementCommunication

Tools & Technologies

ELIMSEmpowerLaboratory Inventory Systems

Industry Keywords

CGMPFDAEMAICHBiopharmaceuticalBiotechnologyPharmaceutical

Tech Stack

Tools & technologies

Spring

About the role

Key responsibilities & impact

Lead and develop a multi-site QC organization of 80+ full-time employees and contractors across Malvern and Spring House
Set QC vision, organization design, operating model, goals, performance expectations, succession plans, and workforce strategy
Oversee QC testing laboratories supporting biotherapeutics and advanced therapies, including cell and gene therapy programs
Ensure sampling, testing, review, approval, and reporting for materials, products, release, stability, environmental monitoring, validation studies, reagents, media, and buffers
Oversee sample management, reference standards, reagents, laboratory inventory, and QC equipment lifecycle management
Oversee analytical platforms and assays including identity, purity, potency, safety, microbiological, molecular, cell-based, and compendial methods
Support method development, qualification, validation, transfer, verification, process performance qualification, continued process verification, and product comparability
Maintain laboratory compliance with cGMP requirements, global quality standards, procedures, data integrity principles, and health, safety, and environmental expectations
Govern investigations, invalid assays, out-of-specification and out-of-trend results, CAPAs, change controls, method transfers, qualifications, and validations
Maintain validated and inspection-ready laboratory systems including eLIMS and Empower
Provide QC data and trend analyses for product reviews, management reviews, investigations, regulatory submissions, and product quality complaint assessments
Establish performance metrics and lead recovery and risk-mitigation plans
Define and execute multi-site QC strategy covering capacity, staffing, budgets, systems, automation, facilities, and capital projects
Partner with Manufacturing, Quality Assurance, Analytical Development, Technical Operations, Supply Chain, Regulatory, Procurement, and external laboratories
Make risk-based decisions regarding staffing, priorities, resources, budgets, testing, quality events, and operational recovery
Serve as senior QC representative during health authority inspections, audits, governance forums, and escalations
Report to the Site Quality Head and serve as a competent delegate when assigned

Requirements

What you’ll need

Bachelor’s degree in biology, biochemistry, microbiology, chemistry, biotechnology, engineering, or a related scientific discipline required
Advanced degree preferred
Minimum of 10 years of relevant, progressive experience in the pharmaceutical, biotechnology, or biopharmaceutical industry
Substantial experience in GMP Quality Control laboratories
Minimum of five years of direct people-management experience
Demonstrated success leading large, complex organizations through multiple layers of leadership
Strong experience supporting biologics or biotherapeutics
Broad knowledge of analytical and microbiological laboratory operations
Knowledge of analytical method lifecycle activities, laboratory investigations, data review, statistical trending, electronic laboratory systems, sample management, and equipment lifecycle management
Strong 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
Ability to make timely, risk-based decisions in a complex regulated environment
Ability to work in laboratory and manufacturing environments
Compliance with gowning, personal protective equipment, health, safety, and site-access requirements

Benefits

Comp & perks

Inclusive work environment
Equal opportunity employment
Interview process accommodations for applicants with disabilities
Periodic travel between Malvern and Spring House
Approximately 10–20% domestic or international travel