Pfizer

Senior Manager – Computer Systems Quality Team Lead

Pfizer

full-time

Posted on:

Location Type: Hybrid

Location: Puerto Rico

Visit company website

Explore more

✨ AI Apply
Apply

Job Level

Senior

Tech Stack

ERP

About the role

  • Provide Quality Authority oversight for Core GMP PGS/ERP computer systems
  • Lead the Core Solution Support team and manage team resources
  • Review and approve GMP related Computer System Standard Operating Procedures
  • Provide guidance on aspects of the systems' life cycle defined by Pfizer GMP policies
  • Support regulatory or internal audits related to GMP core computer system compliance
  • Assist sites in supporting regulatory inspections or internal audits
  • Partner with Digital stakeholders for effective delivery and management of core solutions
  • Facilitate cross-site/function discussion forums

Requirements

  • BA/BS with 6+ years of experience
  • Experience of enterprise system validation/compliance/deployment
  • Knowledge of Pfizer Digital life cycle methodologies (S/ADLC)
  • Experience with computer system validation lifecycle processes and regulations
  • Knowledge of Computer System Quality regulations (e.g. 21 CFR part 11, EU Annex 11)
  • Knowledge of GAMP5 and relevant regulatory current Good Manufacturing Practices (part of GxP)
  • Strong verbal and written communication skills
  • Strong project management skills
  • MBA/MS with 5+ years of experience or PhD/JD with 1+ year of experience or MD/DVM with any years of relevant experience
  • Experience using common AI tools, including generative technologies
Benefits
  • 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score
Applicant Tracking System Keywords

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

Hard Skills & Tools
enterprise system validationcomputer system validation lifecycle processesGMP complianceGxPS/ADLCGAMP521 CFR part 11EU Annex 11project management
Soft Skills
verbal communicationwritten communicationleadershipteam management
Certifications
BABSMBAMSPhDJDMDDVM