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 10/14/2026full-timeBeerse • BelgiumSeniorLead💰 €119,200 - €204,355 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. Proven ability to analyze process KPIs and drive continuous improvements in quality assurance and regulatory compliance.

Highest-signal resume keywords

Quality Assurance ExperienceRegulatory Compliance ExperienceGxP and cGMP KnowledgeGlobal Process StandardizationAnalytical and Decision-Making Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

BPDR Process ArchitectureFAR Process GovernanceAPR/PQR Process ExecutionProcess KPI AnalysisRisk-Based Remediation StrategiesData GovernanceQuality System ProcessesContinuous ImprovementInspection ReadinessCross-Functional Program Leadership

Soft Skills

Influencing SkillsNegotiation SkillsWritten Communication SkillsVerbal Communication SkillsSound Judgment

Industry Keywords

Pharmaceutical IndustryBiotechnology IndustryMedical Device IndustryRegulated IndustryCommunity of Practice

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 assessments and filing decisions
Own global Product Quality Review / Annual Product Review process execution and improvement
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, and management-review reporting
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, support audits and health-authority inspections, and drive remediation
Prioritize risk-based continuous improvements and verify sustained effectiveness
Lead globally dispersed contributors and influence cross-functional stakeholders in a matrix environment
Where applicable, lead employees and contractors, 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
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

Annual bonus with set target (% of pay) depending on pay grade / location, with actual amount based on employee and company performance
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
Several insurance plans for employees and, in some locations, eligible dependents