Global Process Owner, PQ Reporting

6010-Biosense Webster Inc. Legal Entity; Schaffhausen; Sur place; CHF 150 000 - 210 000; Plein temps

Résumé du poste

Johnson & Johnson in Schaffhausen, Switzerland seeks a Global Process Owner for Product Quality Reporting within the Innovative Medicine Quality organization. This role drives BPDR, FAR, APR, and PQR processes across a global matrix, partnering with regulatory, platform quality, and site teams to ensure compliant, data-driven product quality governance.

The position emphasizes global standardization, data governance, and continuous improvement, with responsibility for inspection readiness and

Qualifications

• Bachelor's degree in a life sciences, engineering or related field.
• 12+ years of experience in pharma/regulated environments.
• Strong knowledge of global GxP and cGMP requirements.
• Experience leading global, cross-functional quality programs in a matrix environment.

Responsabilités

• Own end-to-end BPDR/FAR and APR/PQR process architecture, governance, and lifecycle for IM.
• Provide global leadership for BPDR/FAR and ensure timely, compliant filings and decisions.
• Lead APR/PQR governance for end-to-end product quality review processes.
• Integrate product-quality insights across BPDR/FAR, APR/PQR, complaints, investigations, and CAPA.
• Drive a unified, globally consistent process framework with scalable controls.

Connaissances

BPM leadership

Regulatory compliance

GxP knowledge

Data analytics

Stakeholder engagement

Process governance

ISO 9001

Change management

Quality systems

Project management

Formation

Bachelor's degree

Description du poste

At Johnson &Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

Job Function: Quality Job Sub Function: Business Process Quality Job Category: Professional All Job Posting Locations: Schaffhausen, Switzerland

Job Description: We are searching for the best talent for Global Process Owner (GPO), Product Quality Reporting to join our Innovative Medicine Quality organization located in Schaffhausen, Switzerland. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United States - Requisition Number: R-103751 Belgium - Requisition Number: R-104913 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. The Global Process Owner (GPO), Product Quality Reporting, provides Innovative Medicine (IM) end-to-end ownership, governance, and strategic direction for Biological Product Deviation Reporting (BPDR), Field Alert Reporting (FAR), Annual Product Review (APR), and Product Quality Review (PQR). The role establishes a single, sustainable operating framework that connects regulatory reporting, periodic product review, product-risk insight, and Quality governance across the product lifecycle. Working through a global matrix, the GPO drives compliant and consistent process execution, clear decision rights, standardized data and analytics, digital enablement, process performance, inspection readiness, and continuous improvement. The role partners with sites, Platform Quality, Enterprise Quality, Regulatory, IM Regulatory Compliance, product and process owners, technology teams, and other stakeholders while execution remains with the accountable business and site organizations.

Core Accountabilities

• Global process ownership: Own the end-to-end BPDR/FAR and APR/PQR process architecture, governance, standards, and lifecycle for IM. Establish clear scope, decision rights, roles and responsibilities, interfaces, controls, escalation pathways, and execution expectations.
• BPDR/FAR governance and filing decisions: Provide global process leadership for BPDR and FAR. Establish the governance and decision framework needed to support timely, consistent, traceable, and compliant assessments and filings. Serve as, or formally designate through approved governance, the ultimate process-level filing decision authority, consistent with applicable procedures and delegated accountability.
• APR/PQR governance: Act as the global process owner for the end-to-end Product Quality Review / Annual Product Review process. Set direction for sustainable global execution, including data gathering, holistic product review, interpretation of data and trends, risk identification, reporting, review, approval, and follow-through on improvement opportunities.
• Integrated product-quality insight: Connect signals and outputs across BPDR/FAR, APR/PQR, complaints, investigations, NC/CAPA, escalation, continued process verification, stability, and other relevant inputs to strengthen proactive product-risk identification and management.
• Standardization and simplification: Drive one globally consistent process framework while defining the controls needed for justified local or regulatory variation. Simplify workflows, reduce ambiguity, improve traceability, and clarify handoffs among global, regional, platform, site, and functional teams.
• Metrics, management review, and effectiveness: Define, maintain, and analyze process KPIs and quality/compliance metrics, including timeliness, status, quality of execution, trends, recurring issues, and effectiveness. Ensure meaningful process insights are available for the appropriate management-review and Quality governance forums.
• Digital, data, and analytics enablement: Own business requirements and end-to-end data governance for enabling systems, automation, analytics, and reporting. Partner with Digital Quality & Innovation and technology teams to support a coherent digital Quality ecosystem and reliable, inspection-ready data.
• Community, capability, and change: Lead the global Community of Practice and process-owner network. Build process capability through guidance, learning, communications, role clarity, knowledge sharing, and structured adoption of process and technology changes.
• Inspection and audit readiness: Maintain process inspection readiness; support health-authority inspections and audits; ensure timely responses to observations or process gaps; and translate internal and external insights into sustainable improvements. Monitor and influence evolving regulatory requirements.
• Risk-based continuous improvement: Monitor process performance and emerging requirements, prioritize improvements based on compliance and business risk, sponsor remediation when needed, and verify that changes deliver sustained effectiveness.
• Matrix leadership and stakeholder partnership: Lead globally dispersed contributors and influence across functions without reliance on direct authority. Partner with process executors and content owners to enable sound decisions while preserving clear accountability for execution and product decisions. Foster stakeholder alignment with Value Chain Management (VCM) and MSAT to create the network to have aligned input, evaluations and build culture to improve product and processes.
• People and resource leadership: Where applicable, lead employees and contractors, set priorities, manage performance and development, and ensure resources and capabilities are aligned to the highest-risk and highest- value process needs.

Key Deliverables and Measures of Success

• Approved end-to-end process architecture, governance, RACI/decision-rights model, and controlled global standards for BPDR/FAR and APR/PQR.
• Consistent, timely, traceable, and compliant BPDR/FAR assessment and filing performance.
• Effective, risk-based APR/PQR execution that produces meaningful product and process insights and drives follow- up actions.
• Integrated process metrics, dashboards, trend analysis, and management-review reporting with clear ownership for actions.
• A prioritized digital and data roadmap, with business requirements, data ownership, controls, and adoption measures.
• Demonstrated inspection readiness, timely remediation of gaps, and sustained effectiveness of process improvements.
• An active global process-owner network and Community of Practice with clear capability expectations and reusable learning.

Decision Rights

• Sets the global process strategy, target state, governance model, standards, and performance expectations for BPDR/FAR and APR/PQR.
• Approves proposed global process changes and prioritizes the process-improvement and digital roadmap through established QM&D governance.
• Defines escalation criteria and ensures complex or high-risk decisions reach the appropriate accountable governance body.
• Provides or coordinates the designated ultimate process-level BPDR/FAR filing decision authority, subject to approved procedures and legal/regulatory accountabilities.
• Accepts process risks or escalates them to the appropriate Quality governance body when acceptance exceeds delegated authority.

Required Qualifications

• A minimum of a Bachelor's degree is required. Degrees in pharmacy, chemistry, engineering, life sciences, statistics, or a related discipline preferred.
• 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.

Preferred Qualifications

• Advanced scientific, engineering, regulatory, data/analytics, or business degree.
• Direct experience with BPDR, FAR, APR, PQR, product-quality surveillance, continued process verification, health- authority reporting, or related product lifecycle processes.
• Experience as a Global Process Owner, business process owner, product owner, or Quality System owner.
• Experience with global process standardization, digital workflow enablement, data governance, analytics, and inspection-ready reporting.
• Experience supporting GxP audits and health-authority inspections.
• Working knowledge of quality-risk-management and quality-management-system principles.

Required Skills

• Business Process Management (BPM)
• Business Requirements Analysis
• Compliance Management
• Data Savvy
• Fact-Based Decision Making
• Forward Thinking
• ISO 9001
• Mentorship
• Process Governance
• Process Optimization
• Quality Control (QC)
• Quality Standards
• Quality Validation
• Stakeholder Engagement
• Standard Operating Procedure (SOP)
• Tactical Planning
• Tactical Thinking
• Technical Credibility

Preferred Skills

• Business Process Management (BPM)
• Business Requirements Analysis
• Compliance Management
• Data Savvy
• Fact-Based Decision Making
• Forward Thinking
• ISO 9001
• Mentorship
• Process Governance