Senior Manager, Product Quality Integrator

Johnson & Johnson

. Own end-to-end accountability for quality strategy and quality aspects from Early Development through commercialization for assigned large-molecule products .

Posted 10/9/2026full-timeUnited StatesSeniorLead💰 $122,000 - $212,750 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Strategy and Quality Assurance for large-molecule products, with a strong focus on regulatory compliance, risk management, and cross-functional collaboration. Proven ability to lead quality integration and manage quality processes across the pharmaceutical and biotechnology sectors.

Highest-signal resume keywords

Quality Assurance ManagementRegulatory Submissions (IND, BLA, NDA, MAA)CGMP Standards KnowledgeRisk Assessment and ManagementCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Strategy DevelopmentQuality Process OversightTechnology TransferProcess DevelopmentProcess ValidationAnalytical ChemistryProduct Quality ControlQuality Systems ImplementationSignal InvestigationProduct Safety Analysis

Soft Skills

InfluencingNegotiationPresentation SkillsProblem SolvingCommunication

Industry Keywords

Pharmaceutical IndustryBiotechnologyBiotech ManufacturingVaccine DevelopmentSterile ManufacturingQuality ControlRegulatory ComplianceClinical DevelopmentValue Chain ManagementGlobal Quality Processes

About the role

Key responsibilities & impact

Own end-to-end accountability for quality strategy and quality aspects from Early Development through commercialization for assigned large-molecule products
Represent Global Quality on Chemistry, Manufacturing, and Controls (CMC) and Value Chain Teams
Serve as liaison between Value Chain and Analytical groups and as the single point of Global Quality contact
Ensure Quality stage-gate deliverables are achieved
Review and approve health-authority submissions and associated questions, including IND, IMPD, BLA, NDA, and MAA filings
Support pre-approval inspections and agency audits
Define and oversee QA resources for assigned products
Lead Quality new-product integration and Quality sub-teams across clinical, drug substance, drug product, finished form, and device development through launch
Support sites and represent them on CMC and Value Chain teams
Resolve QA communications and issues with external manufacturers and business partners
Ensure global quality processes are used across sites and facilitate Global Quality communication
Manage preparation of PPQS materials, criticality analyses, complaint trends, signal investigations, and product safety team presentations
Complete Transfer of Ownership activities with the Product Quality Owner
Support business continuity planning, proactive product quality scans, product strategy, and end-to-end value-chain mapping
Present project updates, escalate issues, coordinate cross-functional escalation meetings, and track follow-up actions
Participate in IMTs and support field actions and recalls as needed
Drive and coordinate Global Quality decisions and problem solving
Develop and implement quality strategies and product portfolio control-strategy guidelines
Provide quality structure, direction, and decision-making for medium-risk, ambiguous situations

Requirements

What you’ll need

A minimum of a bachelor’s degree (or University equivalent) with a major or concentration in Pharmacy, Biology, Biochemistry, Biotechnology, Engineering, or a similar technical/scientific degree concentration
A minimum of 8 years’ experience in the pharmaceutical or biotechnology industry
Knowledge in cGMP standards, policies and procedures
Demonstrated ability to work across organizational boundaries through presenting, influencing, negotiation and partnering
Ability to quickly assimilate new technologies, perform risk assessment and develop action plans
Flexible hours to accommodate US, EMEA and ASPAC work schedules when necessary
Willingness and ability to travel up to 10% domestically and internationally as business demands
Preferred: Master’s degree or other advanced degree
Preferred: Knowledge of biotech, vaccine, and/or sterile pharmaceutical manufacturing
Preferred: Experience in technology transfer, process development and/or process validation
Preferred: In-depth understanding of quality processes/systems, risk management and manufacturing control strategies
Preferred: Experience developing and responding to quality content of regulatory filings, inspections, and preparedness activities
Preferred: Experience in API and Drug Product stability

Benefits

Comp & perks

Retirement plan (pension)
Savings plan (401(k))
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; Colorado employees – 48 hours; Washington employees – 56 hours
Holiday pay, including Floating Holidays – 13 days per calendar year
Work, Personal and Family Time – up to 40 hours per calendar year
Parental Leave – 480 hours within one year of birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Up to 10 days [as stated in posting]