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.

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

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

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

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

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

Support integration of small markets into the VMG operating model

Contribute to fit-for-purpose quality governance and oversight frameworks

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

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 pharmaceutical industry

Qualified and eligible to act as Responsible Person under EU/Dutch GDP regulations

Strong experience in GDP/GxP environments (pharmaceutical distribution/export preferred)

Solid knowledge of EU and Dutch regulatory frameworks

Experience interacting with Dutch Health Authorities and managing inspections

Proven experience in multi-market and complex supply environments

Key Competencies: Strong balance between compliance and business priorities. Risk-based and pragmatic decision-making. Stakeholder engagement and influencing skills. High accountability and ownership. Ability to operate in a fast-paced, international environment.

Languages: Fluent in English and Dutch

Work Location Assignment: Hybrid

Are you interested?

Do you know enough and have you decided to respond? We are curious about you and invite you to submit your application via the apply button below. The closing deadline for applications is June 30th.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

We kindly ask you to provide your application documents in English!

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Pfizer's aim is to provide equality of opportunity in the recruitment process by avoiding any bias or potential discrimination on any grounds including (but not limited to): sex, age, race, religion or belief, sexual orientation or disability. At Pfizer we are creating an organization and promoting a culture that respects each individual's unique character and life experiences and reflects the diversity of our society, customers and markets. We will achieve this through fostering and sustaining an environment in which every colleague feels valued and supported.

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Quality Assurance and Control