SOQ Senior Manager- Export Markets and Value Maximization Group (VMG)/Responsible Person (RP)

Responsibilities

• Export Markets & VMG Quality Oversight
• Act as above-market Quality Point of Contact (POC) for VMG and Export Markets
• Ensure consistent implementation of QMS across all markets in scope
• Monitor and trend quality performance, risks, and compliance signals
• Governance, Compliance & Operations
• Ensure oversight of distributors, LSPs, and Quality Agreements
• Maintain inspection readiness and support audits and regulatory inspections
• Oversee deviation management, CAPA, change control, and risk processes
• Ensure traceability and compliance in repackaging/relabeling activities
• Maintain and continuously improve the QMS
• 3.Responsible Person (RP) Accountabilities for PEBV
• Act as RP named on PEBV License
• Serve as primary point of contact with Dutch Health Authorities
• Ensure compliance with EU GDP and Dutch regulatory requirements at all times
• Core RP Duties include:
• Ensuring QMS implementation and maintenance
• Oversight of authorized activities and record integrity
• Approval of suppliers, customers, and subcontracted activities
• Ensuring training programs are in place and effective
• Managing recalls, complaints, and product disposition decisions
• Approving returns to saleable stock and handling non-conforming products
• Ensuring self-inspections and CAPA implementation
• Approving SOPs and supporting complex investigations
• Ensuring compliance with national regulatory requirements and license conditions
• Safeguarding product quality across all distribution activities
• Additional Responsibilities
• Quality Culture & Capability Building :
• Promote strong Quality culture across markets and functions
• Provide training and awareness on quality and compliance requirements
• Ensure timely and right-first-time quality documentation
• Business Continuity
• Ensure continuous RP availability and oversight
• Maintain the PEBV License
• Support uninterrupted and compliant product supply
• Pharmacovigilance & Compliance
• Ensure adherence to pharmacovigilance requirements (YRR program)
• Report safety information to Drug Safety Units as required
• Ensure compliance with Business Ethics and regulatory standards
• Support product quarantine, recalls, and communication with LSPs
• Risk-Based Performance & Data Analytics
• Consolidate and analise quality data across markets to identify trends and risks
• Proactively escalate systemic issues and support risk mitigation actions
• Support inspection readiness and continuous improvement initiatives
• VMG Model Expansion & Integration
• Support integration of small markets into the VMG operating model
• Contribute to fit-for-purpose quality governance and oversight frameworks
• Harmonization & Ways of Working
• Drive harmonization of quality processes, tools, and governance
• Ensure consistent application of GDP/GxP and Pfizer GSOPs
• Partner with Cluster and Market Quality Leads to ensure consistent application of GxP/GDP and Pfizer Quality Standards
• Cross-Functional Collaboration
• Act as SOQ interface with Commercial, Medical, Regulatory Affairs, and Global Supply Chain
• Support issue resolution, inspections, audits, and regulatory interactions
• Qualifications & Experience
• Bachelor's degree in pharmacy, Science, Engineering, or related field (required)
• Advanced degree (MSc, MBA, Quality/Regulatory) preferred
• 10+ years in Quality, Compliance, Supply Chain, or Regulatory roles within the pharmaceu

Benefits

Additional Information

Location Netherlands (PEBV License) Registered Responsible Person with Dutch Health Authorities Role Impact This role is critical to ensuring compliant, efficient, and uninterrupted supply across Export Markets while enabling the evolution toward a harmonized VMG operating model and strengthening the link between Quality, Regulatory, and Business objectives. Role Summary The Senior Manager - Export markets and VMG has dual responsibility: VMG Quality Oversight: is responsible to Support the above‑market Quality leadership and oversight of VMG (Value Maximizing Group) markets across Europe, ensuring: Risk‑based, compliant, and harmonized Quality operations Strong governance and performance monitoring across VMG markets Alignment with Pfizer Quality Standards and regulatory expectations Acts as the Quality point of contact (POC) for VMG markets and supports the evolution of small/export markets into the VMG operating model Export Markets Quality Oversight/RP: is responsible for maintaining an effective Quality Management System (QMS) across all Export Markets operating under the PEBV license (+50 markets). The role ensures that Pfizer PEBV products are managed, released, and distributed to logistics service providers (LSPs) and distributors in full compliance with EU Good Distribution Practice (GDP), Dutch Board of Health (BOH) requirements, and Pfizer Global SOPs (GSOPs). The position serves as the designated Responsible Person (RP), acting as the primary point of contact with Dutch Health Authorities, while driving a risk-based, harmonized, and compliant quality operating model across VMG and Export Markets.

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