Supply Operations Quality Specialist

The SOQ team are the main point of contact for the investigation and resolution of all product quality/compliance issues discovered or originating in the Ireland Pfizer Country Office (PCO) and for interacting with the local regulatory authorities (HPRA) and relevant stakeholders (such as Regulatory Affairs Medical) and Pfizer Global Supply (PGS) on such issues.

The Supply Quality Operations (SOQ) Specialist plays a critical role in supporting the Responsible Person (RP) for Good Distribution Practice (GDP) by helping to establish and sustain a robust Product Quality System and a strong Quality Culture within the PCO. This ensures that all products whether physically or financially managed by the PCO comply fully with applicable GDP/GMP requirements.

The SOQ Specialist is responsible for operating within and supporting all aspects of the SOQ Quality Management System (QMS). This includes ensuring that key elements of the QMS are implemented documented and maintained in accordance with Pfizer Corporate policies and relevant regulatory requirements. Additionally the specialist will support and participate in both Pfizer corporate and self-internal audits as well as local regulatory inspections conducted by the HPRA.

Use Your Power for Purpose

Every day Pfizers unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative always putting the patient first. Whether you are involved in development maintenance compliance or research analysis your contribution directly impacts patients.

What You Will Achieve

In this role you will:

• Manage moderately complex projects by planning and prioritising short-term activities efficiently.

• Lead quality investigations and execute Corrective & Preventive Actions (CAPA) to resolve and prevent compliance concerns.

• Liaise with stakeholders to address product quality matters and uphold compliance with GMP/GDP standards.

• Support the RP for GDP in the co-ordination of product quality recalls and/or market actions.

• Oversee complaint handling ensuring alignment with Pfizer policies GMP regulations and thorough investigation/reporting of suspected falsified medicines.

• Assist in the preparation and coordination of Regulatory Authority and Pfizer inspections including audit CAPA support.

• Act as Quality Subject Matter Expert (SME) for new product launches expansions and discontinuations within Ireland.

• Serve as SME for local Standard Operating Procedures (SOPs) initiating updates and overseeing periodic reviews.

• Generate and analyse quality Key Performance Indicators (KPIs) highlighting significant trends and supporting regular management reviews.

• Coordinate local GDP product release activities collaborating with the EU release Hub Supply Chain and Regulatory teams.

• Act as training SME for the Pfizer country office responsible for generation and rollout of training for GDP processes and procedures.

• Support qualification and quality oversight of Pfizer Vendors and Logistics Service Providers (LSP).

Here Is What You Need

(Minimum Requirements)

• Bachelors degree in biology chemistry or a related technical discipline.

• At least 4 years of experience within the pharmaceutical industry preferably in Quality Assurance Quality Control or a technical function.

• Comprehensive understanding of regulatory GDP/GMP compliance associated with the manufacture and distribution of medicinal products.

• Strong critical thinking abilities and a proactive mindset.

• Excellent organisational collaboration and communication skills both written and verbal.

(Preferred Requirements)

• Proficiency with Microsoft Office applications and enterprise systems such as Trackwise and Vault.

• Demonstrated ability to work effectively under pressure and meet deadlines.

• Experience influencing and negotiating with stakeholders.

• Background in conducting internal audits and supporting regulatory inspections.

• Eligibility to act as Deputy Responsible Person.

Work Location Assignment:Hybrid

Make a difference today! All suitable candidates should apply through the link with CV provided. We are looking forward to hearing from you!

In order to be considered for this position you need to be legally eligible to work in the EU.

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

Due to the high volume of applications we will be contacting successful candidates only.

Closing date for applications is October 12th 2025.