Senior Manager, CSSV Business System Owner (Secondment - 12 Months)

WHAT YOU WILL ACHIEVE

• This role provides strategic leadership for development, deployment and enablement of enterprise Digital solutions across QSEO and PGS Operations.

• The Business System Owner (BSO) partners closely with Global Process Owners (GPOs) and Digital to ensure enterprise systems are fit for business use, compliant, and continuously optimized.

• This role acts as the primary business point of contact with Digital for activities including system selection, requirements, risk management, and acceptance for use, as well as ongoing system lifecycle business representation.

• The role is jointly accountable with the GPO for aligning system operations with global standards and business objectives, for triaging and prioritizing enhancement requests and for determining deployment schedules based on network priorities.

• The BSO ensures process specific lifecycle tasks for Digital solutions are understood and managed by appropriate process owners and supports translation of business process/operational requirements into Digital user/functional requirements.

• Additionally, the position supports Computer System Validation & Quality oversight for GMP /GDP Digital systems as necessary, ensuring compliance with Pfizer CSA/SDLC requirements, 21 CFR Part 11, Eudralex Vol 4 Annex 11 & associated global regulations.

HOW YOU WILL ACHIEVE IT

Fulfil the system owner responsibilities for enterprise GMP/GDP systems in the designated business area in partnership with the Digital product owner (as defined in CSA/SDLC processes). Note. The BSO will assume oversight of multiple GMP/GDP Digital solutions as dictated by business needs.

Support and consult with the GPO in:

• Identifying digital needs to support the business process, and associated process optimization and efficiencies, ensuring alignment with business objectives.

• Developing and risk-assessing system requirements during

• Confirming the system meets the specified business requirements

• Ensuring system and data compliance, through data review assessments and provision of central audit trail review instruction

• Prioritization of system enhancements

• Serving as SME during process-specific PCTs for associated L2 processes

• Serving as SME for system-related changes and investigations, deputizing for GPO where appropriate

• Tracking value delivery/ongoing performance of the solution in support of the L2 process

• Collaborate with the CSQ/BUQA function to ensure adequate system validation and ongoing compliance

• Partner and consult with Digital (for both on-prem and SaaS solutions) in:

  • Representing business needs to Digital and engaging with QSEO portfolio management

  • PI planning and scheduling of system/enhancement delivery to meet business expectations

  • Developing network deployment plan, in collaboration with IMOQ and QSEO portfolio lead

  • Liaising with sites to enable timely system deployment and adoption

  • Periodic review of enterprise solutions

  • Retirement and decommissioning of enterprise solutions

  • Supplier selection and assessments

  • Improvement of Digital and/or system performance/support processes

• Serve as business point of contract for assigned Digital systems for all stakeholder groups

• Support internal audits, BOH (Board of Health) inspections and vendor audits.

• Coordinate with other BSOs and GPOs to ensure system and process interdependencies and interfaces are understood and

• Serve as SME in QSEO Digital and AI councils, driving consistency in Digital solution delivery and consumption, and representing business interests

QUALIFICATIONS

Must-Have

• Applicant must have a bachelor's degree with at least 6 years of experience.

• Good understanding of Quality Management System regulations.

• Experience of SMD development and/or Software Quality Assurance, including risk-based approaches (e.g., CSA, GAMP5, QRM).

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

• Demonstrated experience with Quality management and/or computer system validation lifecycle processes.

• Intimate knowledge of Computer System Quality regulations.

• Experience of interacting with auditors and inspectors.

• Experience of computer system/business process ownership.

• Excel