Internal Audit and Inspection Lead

Use Your Power for Purpose

The GMP Internal Audit and Inspection Team Lead is responsible for setting and implementing Pfizer Global Supply (PGS) and PharmSci internal audit strategy in line with regulatory expectations and Pfizer standards. They act as an enterprise leader, ensuring the GMP internal audit and inspection team delivers robust evidence demonstrating risks in regulated processes that inform and allow senior business leaders to take timely and appropriate action.

What You Will Achieve

The Lead is responsible for the overall quality, scientific and technical excellence of PGS and PharmSci internal audits and will represent the RQA GMP/GDP team on key internal workstreams.  The GMP Internal Audit and Inspection Team Lead interfaces with PGS and PharmSci leaders, cross-functional business process owners, Compliance and site Quality leads to secure resources necessary to execute on the audit and inspection strategy. The role directs activities of a matrixed team of RQA auditors and site auditors who perform internal audits within PGS and Pharm Sci sites and central functions.

The GMP Internal Audit and Inspection Team Lead is the PGS global process owner for GMP internal audit and inspection activities, assuring that the organization applies a programmatic approach and is prepared for inspections and audits by regulatory agencies and customers.

The GMP Internal Audit and Inspection Team Lead works with PGS and PharmSci above site Quality Operation and Compliance Leaders, Global Supply Chain, Supply Chain Market Operation Quality, External Supply Operations Quality, Global Technology, Engineering and Launch amongst others, to align, develop and support effective internal audit and inspection programs.

The GMP Internal Audit and Inspection Team Lead works closely with colleagues responsible for audit + inspection planning, training and metrics to incorporate risk signals and to define KPIs from audits and inspections in the overall risk model, to identify and mitigate network level risks.

The GMP Internal Audit and Inspection Team Lead acts as a team leader and mentors Quality Assurance colleagues to develop and grow diverse talent. The Lead may serve as the RQA sponsor for innovative/complex projects.

The GMP Internal Audit and Inspection Team Lead reports to the VP, Head of GMP/GDP and EHS audit.

How You Will Achieve It

• 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

Here Is What You Need (Minimum Requirements)

• 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.

Non-Standard Work Schedule, Travel or Environment Requirements

Travel Required: 20%

Work Location Assignment: Remote

The annual base salary for this position ranges from $204,700.00 to $341,100.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 22.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 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, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Finance & Accounting