CSSV Quality System Senior Specialist

Pfizer • Philadelphia, PA

35d • Hybrid

About The Position

Use Your Power for Purpose 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 In this role, you will: This is a permanent individual contributor role within PGS QSEO, Transformation providing Quality system administration expertise & execution for Enterprise GMP PGS computer systems (e.g., Veeva suite, EDES, SDS etc). This includes workflow, data and configuration management, in support of Data Standards & Governance and associated system validation/acceptance testing (UAT). This role also provides expertise and recommendations on system and process design, and user training, adoption, troubleshooting & audit support as needed, as well as system integrations and ACD. Partner with GPOs & BSOs to ensure the Digital systems are appropriately designed and administered to effectively meet the intended use. Ensure adherence to defined data standards and support associated business-level system configuration and administration activities, as well as template design and/or approvals. Author, collaborate on, and/or approve controlled documents for applicable systems based on industry best practices; ensure documents reflect current Pfizer practices Support system design, development and validation activities related to administration processes. Support technical and data migration activities related to system-to-system integrations and for ACD as needed. Support regulatory or internal audits related to GMP core computer systems as required. Assist sites, as requested, to support regulatory inspections or internal audits related to system administration, and support during the inspection/audit to respond to queries and remediation. Support the CSSV/Revolution IMEx program by delivering on defined metrics and KPIs Partner with Digital stakeholders, business SMEs/GPOs and business Quality as necessary for effective management and site adoption of core solutions. Support Revolution activities related to associated L2 process, including system enhancements and PCT support. Duties can be adjusted based on the group’s requirements and needs.

Requirements

• Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with at least 0 years of experience; OR a PhD with 0+ years of experience; OR associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience
• Experience of enterprise system administration and/or system ownership
• Experience of 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)

Nice To Haves

• Experience of interacting with auditors and inspectors
• Strong understanding of Quality Management System regulations and Pfizer Quality Standards
• Experience of Data science/engineering

Responsibilities

• Provide Quality system administration expertise & execution for Enterprise GMP PGS computer systems (e.g., Veeva suite, EDES, SDS etc).
• Workflow, data and configuration management, in support of Data Standards & Governance and associated system validation/acceptance testing (UAT).
• Provide expertise and recommendations on system and process design, and user training, adoption, troubleshooting & audit support as needed, as well as system integrations and ACD.
• Partner with GPOs & BSOs to ensure the Digital systems are appropriately designed and administered to effectively meet the intended use.
• Ensure adherence to defined data standards and support associated business-level system configuration and administration activities, as well as template design and/or approvals.
• Author, collaborate on, and/or approve controlled documents for applicable systems based on industry best practices; ensure documents reflect current Pfizer practices
• Support system design, development and validation activities related to administration processes.
• Support technical and data migration activities related to system-to-system integrations and for ACD as needed.
• Support regulatory or internal audits related to GMP core computer systems as required.
• Assist sites, as requested, to support regulatory inspections or internal audits related to system administration, and support during the inspection/audit to respond to queries and remediation.
• Support the CSSV/Revolution IMEx program by delivering on defined metrics and KPIs
• Partner with Digital stakeholders, business SMEs/GPOs and business Quality as necessary for effective management and site adoption of core solutions.
• Support Revolution activities related to associated L2 process, including system enhancements and PCT support.

Benefits

• participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary
• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level