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 10/14/2026full-timeBeerse • BelgiumSeniorLead💰 €119,200 - €204,355 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 global process frameworks, manage compliance risks, and drive continuous improvement in quality systems.

Highest-signal resume keywords

Quality Assurance ExperienceRegulatory Compliance ExpertiseGxP and cGMP KnowledgeGlobal Process OwnershipData Governance and Analytics

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 AnalyticsProcess StandardizationQuality Management System PrinciplesHealth-Authority ReportingContinued Process Verification

Soft Skills

Analytical SkillsDecision-MakingInfluencing SkillsNegotiation SkillsCommunication Skills

Industry Keywords

Pharmaceutical IndustryBiotechnology IndustryMedical Device IndustryRegulated IndustryQuality System ProcessesInspection ReadinessCross-Functional ProgramsMatrix EnvironmentProduct Lifecycle ProcessesHealth-Authority Inspections

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 scope, decision rights, roles and responsibilities, interfaces, controls, escalation pathways, and execution expectations
Provide global process leadership for BPDR and FAR and support timely, consistent, traceable, and compliant assessments and filings
Own the end-to-end Product Quality Review / Annual Product Review process
Connect product-quality signals across reporting, complaints, investigations, NC/CAPA, escalation, continued process verification, stability, and other inputs
Drive globally consistent process frameworks, simplify workflows, improve traceability, and clarify handoffs
Define and analyze process KPIs and quality/compliance metrics for management review and Quality governance
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 and build process capability
Maintain inspection readiness, support health-authority inspections and audits, and drive remediation and improvements
Monitor performance and emerging requirements, prioritize risk-based improvements, sponsor remediation, 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, Value Chain Management, and MSAT
Where applicable, lead employees and contractors, set priorities, manage performance and development, and align resources to process needs

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
Demonstrated 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 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

Annual bonus with set target (% of pay) depending on pay grade / location
Vacation days
Parental leave for a minimum of 12 weeks
Bereavement leave
Caregiver leave
Volunteer leave
Well-being reimbursement
Programs for financial, physical and mental health
Service anniversary and recognition awards
Insurance plans for employees and, in some locations, eligible dependents