Vice President, Head of GMP/GDP and EHS Audit

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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 Pfizer’s regulated activities spanning across GMP/GDP: R&D clinical investigational product supply, PGS and PharmSci global manufacturing and distribution for commercial and clinical product supply. In 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 RQA's 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