Manager, Computer System Quality

Use Your Power for Purpose

This is a permanent individual contributor role within PGS QSEO, Transformation providing Quality Authority oversight for Core GMP PGS/ERP computer systems and Artificial Intelligence (AI). 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.

What You Will Achieve

• 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.

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

• Partner with Digital stakeholders, business SMEs and business Quality as necessary for effective delivery and management of core solutions. (i.e. CSQ Partner)

• Participate in the development of PGS Pfizer Quality Standards and Guidelines for computer validation and ERES activities to support PGS needs.

• 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.

• Support Revolution activities related to CSA L2 process

Duties can be adjusted based on the group's requirements and needs.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of
  relevant experience

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

• Demonstrated experience with computer system validation lifecycle processes and regulations

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

• Basic understanding of data analytics, statistics and Artificial Intelligence.

• Excellent communication skills with the ability to build relationships, influence outcomes, and to deliver effective viewpoints or presentations to a variety of audiences.

• Command of the English language

• Be self-motivated and flexible with the ability to work effectively in a dynamic, problem solving environment.

• Ability to work within tight timeframes and respond to changing requirements.

• Ability to interact comfortably with all levels of management and colleagues.

• Ability to work independently and manage multiple projects simultaneously

• Competency in MS Office and other tools (e.g. MS Project)

Bonus Points If You Have (Preferred Requirements)

• Involvement in industry discussion forums on CSV-related topics

• Experience of interacting with auditors and inspectors

• Good understanding of Quality Management System regulations and Pfizer Quality Standards

• Experience of Data science/engineering

Physical/Mental Requirements

• Normal office work environment. Potential extended periods of sitting.
• Minimal travel (less than 10%)
• Position manages no colleagues.
• Position may be required to coach more junior colleagues.
• Colleague receives some supervision, guidance and direction, work assignments from manager/TL and/or senior team members

Work Location Assignment: Hybrid

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

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations.  These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure.  Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable