Global Process Owner, PQ Reporting

Johnson & Johnson

. Own the 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 managing end-to-end BPDR/FAR and APR/PQR processes, ensuring compliance with global GxP and cGMP standards while leading cross-functional teams in a matrix environment. Proficient in data governance, quality assurance, and regulatory compliance, with a strong focus on continuous improvement and inspection readiness.

Highest-signal resume keywords

Global Process OwnershipGxP Compliance Risk ManagementQuality Assurance ExperienceData Governance and AnalyticsCross-Functional Program Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

BPDR Process ManagementFAR Process ManagementAPR Process ManagementPQR Process ManagementQuality Risk ManagementData AnalyticsRegulatory ComplianceQuality Management SystemsProcess ArchitectureKPI Analysis

Soft Skills

Analytical SkillsDecision-MakingInfluencing SkillsNegotiation SkillsCommunication Skills

Industry Keywords

Pharmaceutical IndustryBiotechnologyMedical DeviceCGMPGxPHealth-Authority InspectionsQuality System ProcessesProduct Lifecycle ProcessesContinuous Process VerificationInspection Readiness

About the role

Key responsibilities & impact

Own the end-to-end BPDR/FAR and APR/PQR process architecture, governance, standards, and lifecycle for Innovative Medicine.
Establish governance, decision frameworks, roles, responsibilities, controls, escalation pathways, and execution expectations.
Provide global leadership for BPDR and FAR assessment and filing decisions.
Direct sustainable global execution of Product Quality Review and Annual Product Review processes.
Connect product-quality signals across reporting, complaints, investigations, NC/CAPA, escalation, process verification, stability, and related inputs.
Drive globally consistent process frameworks while managing justified local or regulatory variation.
Define, maintain, and analyze process KPIs, quality/compliance metrics, trends, recurring issues, and effectiveness.
Own business requirements and end-to-end data governance for systems, automation, analytics, and reporting.
Lead the global Community of Practice and process-owner network.
Maintain inspection readiness, support health-authority inspections and audits, and drive remediation and continuous improvement.
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.
Where applicable, lead employees and contractors, manage performance and development, and align resources to high-risk process needs.
Deliver approved process architecture, governance and RACI models, compliant filing performance, integrated metrics and dashboards, digital/data roadmaps, inspection readiness, and process-owner capability.

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, including substantial Quality Assurance and/or Regulatory Compliance experience.
Demonstrated knowledge of global GxP and cGMP requirements and 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 development of risk-based remediation strategies and concise reporting of risk and status.
Strong analytical, decision-making, influencing, negotiation, written, and verbal communication skills.
Demonstrated 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.
Degrees in pharmacy, chemistry, engineering, life sciences, statistics, or a related discipline preferred.
Advanced scientific, engineering, regulatory, data/analytics, or business degree preferred.
Direct experience with BPDR, FAR, APR, PQR, product-quality surveillance, continued process verification, health-authority reporting, or related product lifecycle processes preferred.
Experience as a Global Process Owner, business process owner, product owner, or Quality System owner preferred.
Experience with global process standardization, digital workflow enablement, data governance, analytics, and inspection-ready reporting preferred.
Experience supporting GxP audits and health-authority inspections preferred.
Working knowledge of quality-risk-management and quality-management-system principles preferred.

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 employees residing in Colorado; 56 hours for employees residing in Washington
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
Inclusive interview-process accommodations
Equal opportunity employment