Global Process Owner, PQ Reporting

Johnson & Johnson

. Own end-to-end BPDR/FAR and APR/PQR process architecture, governance, standards, and lifecycle for Innovative Medicine .

Posted 10/13/2026full-timeUnited StatesSeniorLead💰 $150,000 - $258,750 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Assurance and Regulatory Compliance within the pharmaceutical and biotechnology sectors, with a strong focus on GxP and cGMP requirements. Proven ability to lead complex, global programs and drive process standardization, risk management, and continuous improvement initiatives.

Highest-signal resume keywords

Quality Assurance ExperienceRegulatory Compliance ExpertiseGxP and cGMP KnowledgeGlobal Process LeadershipAnalytical and Decision-Making Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Process ArchitectureGovernance StandardsKPI Definition and AnalysisRisk ManagementData GovernanceQuality System ProcessesContinuous ImprovementInspection ReadinessProgram ManagementCross-Functional Leadership

Soft Skills

Influencing SkillsNegotiation SkillsWritten CommunicationVerbal CommunicationSound Judgment

Industry Keywords

Pharmaceutical IndustryBiotechnologyMedical DeviceRegulated IndustryHealth-Authority InspectionsMatrix EnvironmentCommunity of PracticeProcess VerificationEscalation PathwaysProduct Quality Review

About the role

Key responsibilities & impact

Own end-to-end BPDR/FAR and APR/PQR process architecture, governance, standards, and lifecycle for Innovative Medicine
Establish governance, decision rights, roles, responsibilities, interfaces, controls, escalation pathways, and execution expectations
Provide global leadership for BPDR and FAR assessment and filing decisions
Lead global Product Quality Review and Annual Product Review execution
Connect product-quality signals across reporting, complaints, investigations, NC/CAPA, escalation, process verification, stability, and related inputs
Drive global process standardization, simplification, traceability, and clear handoffs
Define and analyze process KPIs, quality/compliance metrics, trends, recurring issues, and effectiveness
Own business requirements and data governance for systems, automation, analytics, and reporting
Lead the global Community of Practice and process-owner network
Maintain inspection readiness and support health-authority inspections and audits
Prioritize risk-based continuous improvements and verify sustained effectiveness
Lead globally dispersed contributors and influence across functions in a matrix environment
Partner with sites, Platform Quality, Enterprise Quality, Regulatory, IM Regulatory Compliance, product and process owners, technology teams, VCM, and MSAT
Lead employees and contractors where applicable, including priorities, performance, development, resources, and capabilities

Requirements

What you’ll need

A minimum of a Bachelor's degree is required
At least 12 years of relevant experience in the pharmaceutical, biotechnology, medical-device, or similarly regulated industry
Substantial Quality Assurance and/or Regulatory Compliance experience
Knowledge of global GxP and cGMP requirements
Experience translating requirements into sustainable global processes and controls
Experience leading complex, global, cross-functional programs or Quality System processes in a matrix environment
Experience identifying and managing GxP compliance risk, including risk-based remediation strategies and concise reporting of risk and status
Strong analytical, decision-making, influencing, negotiation, written, and verbal communication skills
Ability to define strategy and translate it into executable plans, governance, measures, and sustained change
Ability to connect across a large, diverse organization and manage multiple priorities with sound judgment and urgency

Benefits

Comp & perks

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; 48 hours for Colorado employees; 56 hours for Washington employees
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
Inclusive interview accommodations for applicants with disabilities