Senior Manager, Product Quality Integrator

Johnson & Johnson

. Own end-to-end quality strategy and quality aspects from Early Development through commercialization for assigned biological 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 management within the pharmaceutical and biotechnology sectors, with a strong focus on cGMP standards, regulatory compliance, and cross-functional collaboration. Proven ability to lead quality initiatives, manage product portfolios, and support regulatory submissions and inspections.

Highest-signal resume keywords

Quality Strategy DevelopmentCGMP Standards KnowledgeRegulatory Submissions ExperienceCross-Functional CollaborationQuality Process Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality AssuranceRisk AssessmentChange ControlCAPAProcess ValidationTechnology TransferAnalytical ChemistryProduct Safety ManagementQuality SystemsManufacturing Control Strategies

Soft Skills

InfluencingNegotiationPresentationProblem SolvingCommunication

Industry Keywords

Pharmaceutical IndustryBiotechnologyBiotech ManufacturingVaccine DevelopmentSterile Pharmaceutical ManufacturingAPI StabilityProduct Portfolio ManagementValue Chain MappingPre-Approval InspectionsAudit Preparedness

About the role

Key responsibilities & impact

Own end-to-end quality strategy and quality aspects from Early Development through commercialization for assigned biological products
Represent Global Quality on Chemistry, Manufacturing, and Controls 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
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
Manage Product Portfolio Quality Summaries and criticality analyses
Oversee complaint management, product safety team participation, and complaint trend investigations
Complete Transfer of Ownership activities with the Product Quality Owner
Support business continuity processes, proactive product quality scans, product strategy, and value chain mapping
Present project updates, escalate issues, coordinate escalation meetings, and follow up on actions
Participate in issue management teams and support field actions and recalls
Drive and coordinate Global Quality decisions and problem solving
Develop and implement quality strategies and product portfolio guidelines
Provide quality structure, direction, and decision-making for Quality, CMC, and Value Chain teams

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
Knowledge of biotech, vaccine, and/or sterile pharmaceutical manufacturing
Experience in technology transfer, process development and/or process validation
In-depth understanding of quality processes/systems, including change control, event handling, CAPA, risk management and manufacturing control strategies
Experience with developing and responding to quality content of regulatory filings, inspections, and preparedness activities
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 the 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% domestic and international travel as business demands