Senior Quality Lead

Johnson & Johnson

Senior Quality Lead ensuring GMP compliance in Biotechnology at Johnson & Johnson. Collaborating with R&D and supply chain for quality deliverables and oversight.

Posted 7/22/2026full-timeMalvern • Pennsylvania • 🇺🇸 United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Operations within a regulated manufacturing environment, focusing on cGMP compliance, risk assessment, and process improvement. Proven ability to lead teams, manage multiple priorities, and ensure inspection readiness while maintaining high standards of quality documentation.

Highest-signal resume keywords

GMP ComplianceRisk AssessmentQuality Document ReviewTeam LeadershipProcess Improvement

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Management SystemsCGMP RegulationsDocument ControlChange ManagementBatch Record ReviewRegulatory Inspection ProcessesBiotechnology ManufacturingPharmaceutical ManufacturingAnalytical SkillsAttention to Detail

Soft Skills

Interpersonal SkillsCommunication SkillsOrganizational SkillsTeam CollaborationFlexibility

Industry Keywords

BiologicsCell BankingFDA GuidanceEU GuidanceLarge Molecule ManufacturingContinuous ImprovementInspection ReadinessNon-Conformance ManagementChange ControlQuality Deliverables

About the role

Key responsibilities & impact

Partner with Research & Development and Supply Chain teams to support GMP manufacture of cell banks, clinical products, medias, and buffers.
Collaborate with business partners to support new product introductions and manage team to ensure timelines are met for all Quality deliverables.
Represent the lead Quality Operations role at daily huddles, triages, tier meeting, and meetings with business partners.
Maintain GMP environments in inspection ready state by participating and managing scheduled oversight of manufacturing areas.
Review and approve controlled documents including standard operating procedures, work instructions, and risk assessments.
Serve as lead for risk assessments and escalate risks as required.
Ensure all non-conformances are fully investigated and effective corrective/preventive actions are implemented in a timely manner.
Support change management processes including formal change controls by evaluating the proposed changes, assessing impact, providing quality input on implementation plans, and approving changes.
Manage team to provide on time batch record review
Support team with critical alarm review and unexpected event management.
Support in process improvement activities including assessing current processes, providing improvement input and working with partners to implement changes.
Support staff with continuous improvement projects.
Support site inspections and inspection readiness activities.
Train, Develop, Coach, and Mentor employees.

Requirements

What you’ll need

A minimum of a Bachelor’s Degree is required with a focus in Engineering, Biology, Biochemistry, Microbiology, Chemistry, or relevant scientific field/equivalent technical field preferred.
At least 6 years of experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry.
Ability to maintain written records of work performed in paper-based and computerized quality systems.
Ability to quickly process complex information and often make critical decisions with limited information.
Ability to work independently on routine tasks and require some supervision on complex issues.
Ability to be organized and capable of working in a team environment with a positive demeanor.
Manage multiple priorities daily while being flexible and responsive to frequently shifting priorities.
A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills.
Working knowledge of cGMP regulations and FDA/EU guidance related to biologics and cell banking
Preferred Experience in Quality or Manufacturing for Large Molecule Manufacturing
Working knowledge of Phase Appropriate GMP practices.
Experience with document reviews and regulatory inspection processes is preferred.
Demonstrate influencing skills, partnering and collaboration skills, analytical skills, and good oral and written presentation skills.

Benefits

Comp & perks

medical
dental
vision
life insurance
short- and long-term disability
business accident insurance
group legal insurance
consolidated retirement plan (pension)
savings plan (401(k))
long-term incentive program
vacation – up to 120 hours per calendar year
sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
holiday pay, including Floating Holidays – up to 13 days per calendar year
work, personal and family time - up to 40 hours per calendar year