[Remote] Internal Audit and Inspection Lead

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Note: The job is a remote job and is open to candidates in USA. Pfizer is a global leader in the pharmaceutical industry, and they are seeking a GMP Internal Audit and Inspection Team Lead to oversee the internal audit strategy in alignment with regulatory expectations. The role involves leading a team of auditors, ensuring compliance with Pfizer policies, and collaborating with various departments to enhance audit and inspection processes.


Responsibilities

  • Lead direct reports responsible for managing the GMP Internal Audit and Inspection program
  • Directs a team of matrixed colleagues, direct reports and including more than 100 site auditors who are responsible for leading and participating in GMP internal audits
  • Design, execute and govern a comprehensive strategy and associated processes for internal audit and inspection programs including regional strategies in support of all entities within GMP audit universe.
  • Ensure all audits are conducted in compliance with Pfizer policies, Standards and RQA procedures, ensure audit outcomes are calibrated and driven to completion, ensure issues are escalated, and ensure holistic remediation plans and sustainability of CAPA.
  • Challenge, develop and provide feedback on key risks to RQA leadership and business process owners/program owners on a consistent basis
  • Serve as PGS Global Process Owner of GMP Internal Audits and Inspection processes. Work with all PGS sites and global functions to deploy, maintain and continuously improve the health of L2 process.
  • Use signals, data and information provided by PCT, sites, reg intel or other sources, to identify, communicate, and as appropriate escalate risk via risk review forums. Be accountable for mitigation of risks for L2 process
  • Support audits/inspections (Pre/During/Post), including providing back up support to sites as needed, explaining the rationale, process and systems of the GMP internal audit program.
  • Facilitate post-inspection discussions and determine continuous improvement opportunities applicable to the site. Coordinate at PGS/Pharm Sci at global level, the execution of impact assessments of significant findings and observations.
  • Maintaining Knowledge of Industry/Regulatory Trends Collaborate and communicate with internal partners and industry peers on best practices, keep and revolutionize audit process current to industry standards to meet regulatory expectations, intelligence and requirements.
  • Liaise with other GMP/GDP audit team leaders and audit leads and RQA Strategic Operations to ensure a fully integrated GMP audit strategy
  • Measure performance of matrixed team and hold team accountable for internal KPIs to deliver a strong audit program
  • Provide coaching and mentoring to RQA and PGS site auditor colleagues to develop and grow talent
  • Represent RQA or participate on relevant governance committees

Skills

  • Applicant must have a bachelor's degree with at least 12 years of experience; OR a master's degree with at least 10+ years of experience; OR a PhD with 7+ years of experience
  • 7+ years in a management role with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities
  • Expertise and strong background in GMP/GDP, EHS or other related regulated areas
  • Prior teaching and coaching experience as a People Manager
  • Proven ability to think innovatively and to develop and execute strategic plans pursuant to the responsibilities of the role
  • Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Benefits

  • Participation in Pfizer’s Global Performance Plan with a bonus target of 22.5% of the base salary
  • Eligibility to participate in our share based long term incentive program
  • 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 to include medical, prescription drug, dental and vision coverage

Company Overview

  • Pfizer is a biopharmaceutical company that discovers, develops, and delivers medicines and vaccines. It was founded in 1849, and is headquartered in New York, New York, USA, with a workforce of 10001+ employees. Its website is http://www.pfizer.com.

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