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

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.

Key Responsibilities

1.  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

2. 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

4. 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

5. VMG Model Expansion & Integration
Support integration of small markets into the VMG operating model
Contribute to fit-for-purpose quality governance and oversight frameworks

6. Harmonization & Ways of Working
Drive harmonization of quality processes, tools, and governance
Ensure consistent applicati