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Sr. Manager, Qa Auditor

2+ years
Not Disclosed
10 Nov. 13, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About the Role:

The Senior Manager, Auditor is responsible for overseeing and executing Pfizer's global Quality Assurance (QA) program audit activities across assigned projects, products, vendors, and third-party organizations (PCOs). This role ensures compliance with Good Clinical Practice (GCP) and/or Pharmacovigilance (PV) regulations, while guaranteeing adherence to Pfizer's Standard Operating Procedures (SOPs), policies, and relevant global regulatory guidelines (e.g., US FDAEU DirectivesICH, and local regulations).

Role Responsibilities:

Operational Excellence:

  • Assess Compliance: Evaluate GCP compliance at clinical trial sites, processes, and vendor activities, ensuring alignment with global regulatory guidelines and Pfizer policies.
  • Audit Leadership: Independently conduct a wide range of routine and complex audits, including investigator site audits, vendor audits, and support Due Diligence assessments with minimal oversight.
  • Regulatory Support: Actively support regulatory inspections and serve as a strategic partner to the R&D China team, focusing on inspection readiness and self-assessment processes.
  • Process Improvement: Advise on audit outcomes and recommend improvements to internal processes. Lead efforts to implement continuous quality improvements.
  • Audit Reports Review: Review audit reports from outsourced and routine audits, ensuring accuracy, completeness, and compliance with relevant regulations.
  • Risk Management: Assess audit plans and quality metrics to identify areas of potential risk. Recommend actions to mitigate risks and enhance quality assurance.
  • Internal/External Awareness: Lead awareness sessions on GxP topics for internal and external stakeholders, promoting adherence to quality standards.
  • Cross-Location Collaboration: Work with RQA colleagues across Pfizer locations to ensure a consistent approach to audits and promote the standardization of quality assurance practices.
  • Regulatory Environment: Actively participate in discussions related to regulatory changes and advise the team on the potential impact of new regulatory requirements.
  • Business Advisory: Provide strategic insights to business representatives on complex audit outcomes and suggest actionable process improvements.

Leadership:

  • Audit Practices Improvement: Continuously work on refining audit practices and share knowledge with RQA colleagues to meet evolving business needs.
  • Compliance Guidance: Act as a resource for Pfizer’s China R&D team, offering compliance advice and influencing continuous improvement in quality controls and practices.

Quality/Risk Management:

  • Project Team Member: Serve as a member of relevant project teams, providing compliance guidance to drive quality improvements and ensure effective quality controls.
  • Influence RQA Strategy: Engage proactively with RQA and Pfizer China R&D to address changing GxP business needs, ensuring the alignment of audit practices with regulatory changes.

Work Location Assignment:

On-Premise

Equal Employment Opportunity:

Pfizer is committed to being an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction where it operates.


Purpose
At Pfizer, we are dedicated to ensuring the highest standards of quality and compliance across our operations. As a Senior Manager, Auditor, your role will be pivotal in maintaining Pfizer’s commitment to excellence and patient safety through robust audit practices and continuous quality improvement efforts.