Pfizer

Manager, Computer System Quality

Pfizer

full-time

Posted on:

Location Type: Hybrid

Location: Philadelphia • Pennsylvania • 🇺🇸 United States

Visit company website
✨ AI Apply
Apply

Salary

💰 $96,300 - $160,500 per year

Job Level

Mid-LevelSenior

Tech Stack

ERP

About the role

  • Provide Quality Authority oversight for Core GMP PGS/ERP computer systems and Artificial Intelligence (AI).
  • 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.
  • 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 regulatory or internal audits related to GMP core computer system compliance as required.
  • Assist sites to support regulatory inspections or internal audits related to CSV/ERES.
  • Partner with Digital stakeholders, business SMEs, and business Quality for effective delivery and management of core solutions.

Requirements

  • 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)
Benefits
  • 401(k) plan with Pfizer Matching Contributions
  • Additional Pfizer Retirement Savings Contribution
  • Paid vacation
  • Holiday and personal days
  • Paid caregiver/parental and medical leave
  • Health benefits including medical, prescription drug, dental, and vision coverage

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
computer system validationGMP compliancedata analyticsstatisticsArtificial Intelligenceenterprise system validationPGS Revolution CSA processS/ADLC methodologiesGAMP521 CFR part 11
Soft skills
communication skillsrelationship buildinginfluencing outcomespresentation skillsself-motivatedflexibilityproblem solvingtime managementindependenceproject management