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

Pfizer•Philadelphia, PA

3d•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

Master's degree with at least 5 years of experience; OR a PhD with 1+ years of relevant experience.
Involvement in industry discussion forums on QMS/CSV-related topics.
Experience of software development, validation, risk management and delivery.
Experience of Data science/engineering.
Experience in Artificial Intelligence qualification and usage in regulated environments

Responsibilities

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).
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

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