SOQ Officer - Upjohn

JOB FOCUS
Establish and maintain an appropriate and sustainable Product Quality System and Quality Culture within Pfizer and any contractor related to GMP/GDP activities, so that compliance with Pfizer, EU GDP/GMP requirements and local Regulatory authority expectations and protection of Pfizer patients/customers from any product quality risk are ensured. SOQ is the main point of contact for the investigation and resolution of all product quality issues discovered or originating in the Country Office (CO)/ Distribution Center (DC) and for interacting with the relevant stakeholders and local regulatory authorities on such issues. Coordinates and monitors the product quality and compliance activities at the CO/DC to ensure that current regulatory expectations are met and facilitates internal and regulatory GDP inspections.
JOB SUMMARY - MAIN AREA'S OF RESPONSIBILITY / ACCOUNTABILITIES
1- Regulatory Compliance
Ensure adherence to local and global GDP/GMP regulations.
Support the Qualified Person in product quality compliance activities.
Implement and maintain quality systems within the CO/DC.
2- Quality Governance & Documentation
Implement and maintain applicable quality SOPs.
Conduct internal self-inspections and regulatory audits.
Monitor and report quality metrics for CO/DC performance assessment.
3- Training & Compliance Oversight
Ensure all CO/DC staff receive training on quality SOPs and GDP/GMP.
Track training completion and refresher programs.
4- Deviation & CAPA Management
Investigate and resolve product quality incidents.
Manage corrective and preventive actions (CAPA) and track closure.
5- Product Complaint & Recall Management
Process and classify product complaints.
Coordinate recalls and market actions with regulatory authorities.
6- Change Control Management
Oversee planned changes impacting GDP/GMP compliance.
Ensure proper approvals and implementation.
7- Inspection & Audit Support
Support internal and external regulatory inspections.
Follow up on CAPA implementation from audits.
8- Contractor & Logistics Oversight
Ensure compliance with local storage, transportation, and repackaging/relabeling operations.
Maintain and update quality agreements with third parties.
9- Controlled Substance Coordinator
Ensure compliance with regulations on controlled substances storage and distribution.
Maintain records and reconcile controlled substance inventory.
Support audits and inspections related to controlled substances.
KEY PERFORMANCE INDICATORS (KPI)

• Compliance with GDP/GMP and local regulatory requirements.
• Timely closure of CAPAs, deviations, and complaints.
• Successful internal/external audit outcomes.
• Accuracy and timeliness of product disposition decisions.
• Effective management of market actions and recalls.
• Full compliance with controlled substance handling and reporting requirements.
• Works according to relevant SOP / WI.

QUALIFICATIONS

• Level of Education: Pharmacist
• Experience: 0-5 years in pharmaceutical quality or a regulated industry
• Languages: Proficiency in English and French (Intermediate or higher)
• Computer skills: Proficiency in Microsoft Office Suite and quality management systems (QMS)

COMPETENCIES - PERSONAL CAPABILITIES

• Strong analytical and problem-solving skills
• Ability to work cross-functionally and collaborate with stakeholders
• Attention to detail and compliance mindset
• Ability to manage multiple tasks and meet deadlines
• Effective communication and documentation skills

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