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 leadership in managing multi-site Quality Control operations, ensuring compliance with cGMP standards, and overseeing analytical methods for biotherapeutics and advanced therapies. Proven ability to develop and execute strategic QC initiatives while managing large teams and complex laboratory environments.

Highest-signal resume keywords

GMP Quality ControlBiotherapeutics ExperienceMulti-Site Operations ManagementAnalytical Method LifecyclePeople Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Analytical Method DevelopmentLaboratory InvestigationsData ReviewStatistical TrendingSample ManagementEquipment Lifecycle ManagementCell and Gene Therapy TestingRegulatory CompliancePerformance Metrics EstablishmentRisk Mitigation Planning

Soft Skills

LeadershipCollaborationDecision-MakingCommunicationProblem-Solving

Tools & Technologies

ELIMSEmpowerLaboratory Inventory SystemsAutomated Systems

Industry Keywords

CGMPFDAEMAICHBiopharmaceuticalPharmaceuticalBiotechnologyAdvanced TherapiesQuality AssuranceHealth Authority Inspections

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 the QC vision, organization design, operating model, goals, performance expectations, succession plans, and workforce strategy
Exercise leadership authority for talent acquisition, performance management, development, recognition, compensation recommendations, promotions, employee relations, organizational design, and corrective actions
Oversee 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 materials, products, environmental monitoring, validation studies, reagents, media, and buffers
Oversee sample management, reference standards, critical 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
Ensure execution of method development support, qualification, validation, transfer, and verification activities
Maintain laboratory compliance with cGMP requirements, global quality standards, procedures, data integrity principles, and health, safety, and environmental expectations
Govern and close investigations, invalid assays, out-of-specification and out-of-trend results, CAPAs, change controls, method transfers, qualifications, and validations
Maintain validated and inspection-ready computerized laboratory systems, including eLIMS and Empower
Provide QC data and trend analyses for product reviews, management reviews, investigations, regulatory submissions, and complaint assessments
Establish and monitor laboratory performance metrics and lead recovery and risk-mitigation plans
Define and execute multi-site QC strategy covering capacity, staffing, scheduling, assets, facilities, digital systems, automation, budgets, 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, internal audits, governance forums, and escalations
Report to the Site Quality Head and serve as a competent delegate when assigned
Travel periodically between Malvern and Spring House and approximately 10–20% domestically or internationally

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
Experience leading large, complex organizations through multiple layers of leadership
Strong experience supporting biologics or biotherapeutics
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
Ability to work in laboratory and manufacturing environments
Compliance with applicable gowning, personal protective equipment, health, safety, and site-access requirements
Approximately 10–20% domestic or international travel
Direct experience with advanced therapies, particularly cell and gene therapy testing, strongly preferred
Experience with organizations comparable to 80+ employees and contractors strongly preferred

Benefits

Comp & perks

Inclusive work environment
Equal employment opportunity
Accommodation support for applicants with disabilities