Inspection Information & Metrics Manager (Secondment - 12 Months)

Why Patients Need You

Every day everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture which is both science and risk-based is designed to be flexible innovative and customer-oriented. Whether your role involves development maintenance compliance or analysis through research programs your contribution is crucial and will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards making a meaningful difference in the lives of those we serve.

What You Will Achieve

The Audit and Inspection Information and Metrics Manager is responsible for managing global inspection information process and tools providing user support generating and reporting metrics and optimizing processes. This role involves centralized management of inspection information and analyzing and reporting inspection and inspector data. The manager will also serve as the PGS eQMS ADX business process owner leads and participates in user councils and support meetings and other continuous improvement initiatives.

How You Will Achieve It

• Be responsible for overseeing the centralized inspection information processes and data repositories (SharePoint Trackwise eQMS ACE) ensuring that inspection data is accurately recorded and maintained. This includes oversight of inspection summary reports inspection documentation and observations data.

• Facilitate PGS site Inspection Management by conducting detailed analysis trending and reporting on both internal and external inspection and inspector intelligence and providing inspection data analysis on external companies.

• Monitor analyze and report on FDA Warning Letters quarterly.

• Support Internal Audit Central Planning by scheduling audits across the PGS PharmSci SOQ and ESOQ networks to ensure they are properly planned and resourced.

• Act as the PGS eQMS ADX business processes owner. Lead the PGS eQMS ADX User Council and represent PGS at Tier 2 Governance sessions meetings and Program Increment planning meetings.

• Oversee the review and prioritization of PGS process and enhancement requests and impact assessment of enhancement requests from other business lines. Assist with enhancement testing and business value analysis

• Serve as the single point of contact for PGS eQMS ADX users. Facilitate question and concern resolution knowledge sharing capability building and data/metric requests.

• Be responsible for generating analyzing and reporting metrics related to Audit and Inspection Management including Internal Audit Data Integrity Pfizer Impact Report Safety and Quality KPIs and Transformation Risk Management metrics.

• Support QMS Revolution 2.0 and other Audit and Inspection Management process or system initiatives.

Qualifications

Must-Have

• Applicant must have a bachelors degree with at least 5 years ofexperience; OR a masters degree with at least 3 years of experience; ORa PhD with 0 years of experience; OR as associates degree with 8 yearsof experience; OR a high school diploma (or equivalent) and 10 years of relevant experience.

• Experience in GMP/GDP manufacturing quality or technical organization in the biopharmaceutical industry.

• Experience supporting internal audits and regulatory inspections.

• Demonstrated ability to assess and improve processes and systems.

• Excellent communication leadership and facilitation skills.

• Proven ability to lead cross-functional teams and manage multiple stakeholders.

• Strong analytical skills and experience in data analysis and reporting.

• Strong problem-solving skills and attention to detail.

• Proven ability to work independently and manage competing priorities.

• Must be self-motivated and flexible to support PGS sites across the global network.

• Experience working within complex global organizations.

Nice-to-Have

• Experience with Power Automate and Power BI.

• Experience with Pfizers UDH.

• Strong project management skills.

• Ability to adapt to changing priorities and manage multiple tasks simultaneously.

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

Flexible work hours to support a global operation

Other Job Details

• Last Date to Apply for Job:August 4 2025

• Additional Location Information:Europe - Remote

• Eligible for Relocation Package NO

• Secondment 12 months

• If you are currently in a driving position with a fleet vehicle and this secondment does not require driving as an essential function of the position for12 months or longer you will be required to turn in your fleet vehicle for the duration of the non-driving secondment. Please refer to the Fleet Policy and Procedures document for more information.

• There will be no change to your current work location.

• Position is considered Flexible and colleagues are expected to comply with Log In For Your Day(LIFYD) requirements at site location (e.g. about 2.5 days a week in office).

Relocation assistance may be available based on business needs and/or eligibility.