Senior Manager - Computer Systems Quality Team Lead (Secondment -12 Months)

WHY PATIENTS NEED YOU

Every day, Pfizer’s 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

This is a secondment team lead role within PGS QSEO providing Quality Authority oversight for Core GMP PGS/ERP computer systems (including Artificial Intelligence). This includes PGS/ERP Quality oversight responsibilities for Core computer system validation and life cycle deliverables, change control, investigations, and periodic reviews, etc.

This role also provides PGS Quality review and approval for related GMP SOPs, and Subject Matter Expert validation guidance to internal customers (e.g. Digital, PGS sites) on GMP computer system and ERES compliance, including risks, standardisation, CSA approaches and strategies.

The role leads the Core Solution Support team and is responsible for team resource forecasting, management and monitoring

Serve as AILC process lead, supporting the global process owner with relevant activities.

HOW YOU WILL ACHIEVE IT

Duties include but are not limited to the following: 

• Team leadership to ensure appropriate GMP Digital solution delivery and ongoing compliance and audit readiness

• PGS Quality Authority review/approval for specific Pfizer GMP Core Digital solution documentation including validation documents, change management records, GMP investigations, and periodic reviews.

• Quality guidance and support to the GMP Core computer systems teams on aspects of the systems’ life cycle as defined by the Pfizer GMP policies and procedures e.g. Risk assessments, Validation Plans, Strategies, Protocols, GMP requirements, verification testing and Validation summaries including deviations, system change controls and periodic reviews. PGS/ERP Quality review/approval for GMP related Computer System Standard Operating Procedures

•  Quality expertise and counsel for computer systems validation and use/maintenance of Electronic Records and Electronic Signatures (ERES).

•  Support regulatory or internal audits related to GMP core computer system compliance as required.

•  Assist sites, as requested, to support regulatory inspections or internal audits related to CSV/ERES. This may include review of draft regulatory observation responses, and support during the inspection/audit to respond to queries and remediation.

• Leadership of CSQ support pillars, including defining/ executing pillar strategy and demonstrating success through metrics

•  Support the CSSV IMEx program by delivering on defined metrics and KPIs

•  Coach other CSQ team members as necessary (manager/secondee level)

•  Partner with Digital stakeholders, business SMEs and business Quality as necessary for effective delivery and management of core solutions

• Participate in the development/revision of PGS Pfizer Standards and Guidelines for computer validation and ERES activities to support PGS needs (i.e., Revolution)

• Facilitate cross-site/function discussion forums (e.g. CSV CIG) to share Digital developments, best practices, and industry trends, and to enable site SME input into Pfizer guides and PQSs.

• Deputies for CSSV Lead role as needed for key initiatives

QUALIFICATIONS

Must-Have

• BA/BS with 6+ years of experience.

• Experience of enterprise system validation/compliance/ deployment and intimate knowledge of Pfizer Digital life cycle methodologies (S/ADLC).

• Demonstrated experience with computer system validation lifecycle processes and regulations.

• Intimate knowledge of Computer System Quality regulations (e.g. 21 CFR part 11, EU Annex 11, Data Integrity guidance) and GAMP5.

• Broad knowledge of relevant regulatory current Good Manufacturing Practices (part of GxP) audit frameworks that apply to pharmaceutical operations, its trends and expectations, and familiarity with other Good Practice concepts and global regulations.

• Strong verbal and written communication, including presentat