Vice President, Head of GMPGDP and EHS Audit

USE YOUR POWER FOR PURPOSE

The Head GMP/GDP & EHS Audit is responsible for the strategic design and management of an integrated risk-based audit strategy across multiple areas of Pfizers regulated activities spanning across GMP/GDP: R&D clinical investigational product supply PGS and PharmSci global manufacturing and distribution for commercial and clinical product addition for EHS audit this role is responsible for setting the global level 2 EHS audit strategy across the Pfizer enterprise (all Pfizer locations).

This leader utilizes external and internal risk intelligence to design and manage a holistic risk-based audit strategy in their areas of accountability that delivers high quality audits of Pfizer global processes Pfizer manufacturing distribution sites and laboratories Pfizer Country Office GMP/GDP activities Pfizer R&D and Commercial Offices EHS activities and operations performed by GMP and Good Distribution Practice vendors including contract manufacturers and suppliers to assure the quality and safety of Pfizer clinical and commercial products colleague safety integrity of data supporting Pfizer registrations and adherence to global GMP/GDP and EHS regulations.

The role ensures Pfizer quality and EHS standards are aligned with key industry trends and regulatory expectations to drive continuous improvement in the Pfizer Quality and EHS Management Systems and overall quality and EHS performance across the Pfizer enterprise.

This leader acts as a strategic partner to global functional line leadership (e.g. PGS Commercial) and supporting functions (e.g. Legal Corporate Audit). This role is a team leader and mentors Quality Assurance colleagues to develop and grow diverse talent.

Leadership

• Acts as an enterprise leader in Quality and EHS influencing and partnering with functional line leadership to develop a robust and holistic quality assurance and EHS audit strategy to support identification of quality risk areas which includes integration of inputs from functional line groups (level 1) Corporate Audit (level 3) and Corporate Compliance.

• Acts as a strategic advisor on key enterprise initiatives that could impact Quality or EHS excellence. Sets behavioral and relationship building standards and leverages constructive relationships to achieve broad business goals. Holds their team accountable for responsibilities.

• Sets a high standard for future leaders identifies leadership potential and develops the next generation of leaders across division and partner functions. Searches for and selects strong leaders to develop a diverse talent pipeline. Imports and exports key leaders across organization boundaries by mapping and deploying key talent against critical business strategies.

• Innovates to create new enterprise focused strategies and solutions constantly seeks opportunities and creative ideas to improve value and contribution to the enterprise.

• Accountable for proactively identifying and including quality risks and mitigation scenarios in partnership with PGS Functional lines Pfizer leaders.

GMP/GDP & EHS Audit Strategy

• Develops leads and represents to senior leadership RQAs comprehensive and integrated audit strategy for GMP and EHS across Pfizer

• Ensures appropriate use of audit and technology-based skills within RQA and sites to assemble audit teams.

• Oversees and is accountable for all audit activities within GMP/GDP (including processes vendors and country offices) and EHS (Pfizer sites) and effectively oversees complex quality audit plans and is accountable for communication of the RQA GMP/GDP and EHS audit strategy across Pfizer functions Globally

• Effectively oversees complex quality and EHS audit and assessments across multiple Pfizer functional areas including vendors/strategic partners for quality audits.

• Has direct accountability for the QA and EHS audit operational strategies for all GMP/GDP and EHS systems including strategy for quality risk assessment defining audit targets audit conduct reporting and business due diligence support

• Ensures adequate resourcing technology & expertise for group and where applicable engages external subject matter expertise consultants or third-party audit services.

Risk/Quality Management

• Is a member of the PGS Quality and Risk Committee partners with cross functional leadership and the PGS QRC in the development of strategies specifically by proactively identifying risks providing guidance on risks and partnering with leadership to oversee mitigations across global or site level functions including across third parties

• Collaborates with business leadership and Legal regarding responses to internal audit and / or regulatory inspection findings received related to Pfizer quality and EHS processes as well as CAPA management.

• Represents Pfizer quality strategies at industry forums and regulatory agency interactions.

• Speaks to Pfizer quality strategies and processes during regulatory authority inspections and Quality Governance activities ensuring the development of robust action/commitment plans in response to external Health Authority requirements or observations.

• Is an adept strategic partner across enterprise quality functions who is focused on aligning quality strategies and driving oversight including strategic vendors and service providers

Operational Excellence

• Identifies and leads the creation of solutions for highly complex quality issues or risk areas

• Provides reporting of quality and EHS audit performance to leadership at site and global level as well as executive summaries of performance and trends across Pfizers key functional business functions.

• Communicates to senior leader governance bodies (e.g. Functional leadership PGS Quality and Risk Committee) on audit plans and critical quality information

• Is accountable for creating an environment where continuous improvement opportunities are actively identified across RQA and enterprise

• Interprets industry and Health Authority trends new and/or revised regulations and industry best practices to define decisions/strategies across multiple functional areas.

• Oversee strategic process design and improvement initiatives to ensure integrated streamlined and efficient audit processes.

People Management

• Grow leaders by providing challenging and stretching tasks and assignments is aware of each direct reports goals mutually constructs compelling development plans and executes them encourages people to accept developmental moves

• Leads others to align with RQA culture values and mission. Communicates a compelling and inspired vision and sense of core purpose talks beyond today creates mileposts and symbols to rally support behind the vision to inspire and motivate their team.

QUALIFICATIONS

• Bachelors degree or equivalent experience is required.

• 15 years relevant experience in developing and leading risk management programs (e.g. in Quality Safety Environmental) and a good understanding of relevant regulatory frameworks that apply to biopharmaceutical operations.

• 8 years in a management role with proven accountability and demonstrated excellent interpersonal communication negotiation influencing and problem-solving capabilities

• Advanced academic qualification/degree is preferred; Masters Degree with 13 years of relevant experience.

• 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%

Other Job Details:

• Last day to Apply: November 16th 2025

• Work Location Assignment:Hybrid

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