Associate Director, Quality Control

6014-Janssen Biotech, Inc. Legal Entity; Malvern (Chester County); Presencial; USD 150.000 - 200.000; Jornada completa

Descripción de la vacante

Johnson & Johnson seeks an Associate Director, Quality Control to lead QC operations across Malvern and Spring House. This role oversees testing strategy, method lifecycle, data review, investigations, and capacity for biologics and advanced therapies.

You will manage 80+ staff and ensure inspection readiness, quality, and supply continuity. You will partner with Manufacturing, QA, Analytical Development, Regulatory, and external labs to maintain product quality and patient safety in a complex,

Formación

• Bachelor’s degree in biology, biochemistry, microbiology, chemistry, biotechnology, engineering or a related field.
• 10+ years of relevant, progressive experience in pharma/biotech QC with GMP labs.
• Minimum of five years of direct people-management experience, managing 80+ employees and contractors.
• Strong experience with biologics/biotherapeutics and cell/gene therapy testing.

Responsabilidades

• Provide strategic, multi-site QC leadership for Malvern and Spring House laboratories.
• Ensure compliant, reliable testing across identity, purity, potency, safety, and related assays.
• Maintain data integrity and inspection readiness of laboratory systems and CAPA processes.
• Collaborate with Manufacturing, QA, Regulatory, and external labs to protect product quality and supply continuity.

Conocimientos

People leadership

Quality compliance

Cross-functional collaboration

Laboratory oversight

cGMP knowledge

Educación

Bachelor’s degree in biology/biochem/chemistry/biotech/engineering

Advanced degree preferred

Herramientas

eLIMS

Empower

Descripción del empleo

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

Job Function

Quality Job Sub Function: Quality Control Job Category: People Leader All Job Posting Locations: Malvern, Pennsylvania, United States of America, Spring House, Pennsylvania, United States of America

Position Information

Title: Associate Director, Quality Control Department Name: Quality Control Reports To: Site Quality Head Location: Malvern (primary) and Spring House (secondary), Pennsylvania

Position Summary

The Associate Director, 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 Malvern and Spring House. This position is a member of the Site Quality Leadership Team and reports directly to the Site Quality Head. The role provides end-to-end oversight of laboratory operations supporting clinical and commercial products, including testing strategy, method lifecycle, data review, investigations, capacity, resources, and inspection readiness. The Associate Director leads an organization of 80+ full-time employees and contractors across both sites. This leader establishes an integrated operating model, develops leaders and technical talent, ensures timely delivery of high-quality test results, and partners with Manufacturing, Quality Assurance, Analytical Development, Technical Operations, Supply Chain, Regulatory, and external laboratories to protect product quality, patient safety, and supply continuity. The incumbent is expected to serve as a competent delegate for the Site Quality Head, as assigned.

Key Responsibilities

• People Leadership & Strategy 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.
• Multi-Site QC Laboratory Oversight Provide integrated oversight of QC testing laboratories supporting biotherapeutics and advanced therapies, including cell and gene therapy programs, across Malvern and Spring House. 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, as applicable. Oversee sample management, reference standards, critical reagents, laboratory inventory, and the qualification, calibration, maintenance, and lifecycle management of QC equipment. Oversee the lifecycle of diverse analytical platforms and assays, including identity, purity, potency, safety, microbiological, molecular, cell-based, and compendial methods, with appropriate controls for complex and time-sensitive advanced therapy products. Ensure effective execution of method development support, qualification, validation, transfer, and verification activities, together with 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. 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 leading and lagging 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.
• Technical Strategy, Business Partnership & Inspection Readiness 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 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 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.

Qualifications & Experience

• 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, with substantial experience in GMP Quality Control laboratories.
• Minimum of five years of direct people-management experience, with demonstrated success leading large, complex organizations through multiple layers of leadership; experience with organizations comparable to 80+ employees and contractors strongly preferred.
• Strong experience supporting biologics or biotherapeutics; direct experience with advanced therapies, particularly cell and gene therapy testing, is strongly preferred.
• 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.

Travel & Working Conditions

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

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: Converts 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 elevate 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.

Diversity & Inclusion

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law.

We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

Company Background

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.