Use Your Power for Purpose Everything we do every day is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based quality culture is both flexible and innovative, always putting the customer first. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that every step we take is aligned with our mission to improve patient outcomes. What You Will Achieve In this role, you will: Develops a comprehensive audit strategy to assess compliance of Pfizer global/end to end processes and the portfolio against applicable government agency GCP regulations and guidelines, in addition to Pfizer standards Maintains good working knowledge of stakeholder organization, change drivers and GCP processes and the portfolio, in order to properly develop audit focus areas around key risks Ensures process and program specific audit standards are well calibrated against regulatory expectations and interpretations, and audit outcomes driven to completion, issues escalated, and risks effectively mitigated through design of holistic remediation plans and effective CAPA Manages stakeholders, including senior business leaders, resolves conflict, and drives alignment related to audit impacts across multiple functional groups Leads process improvement programs to enhance audit program, standards or cross functional alignment of risks Leads a team of experienced auditors capable of executing complex process and digital medicines audits or other novel audit types Measures performance of group and holds team accountable for internal KPIs to deliver a strong audit program Collaborate with the RQA Audit Business Process Owner (BPO) to ensure appropriate auditing standards are set and consistently applied Interprets internal and external industry quality trends to drive currency in audit standards aligned with regulator’s evolving expectations Interfaces with regulatory authorities to represent the audit program during regulatory inspection and represents Pfizer’s position at industry forums Provides coaching and mentoring to RQA colleagues to develop and grow talent Brings a unique understanding/perspective relative to regulatory/compliance requirements and utilizes audit and inspection intelligence to identify risk mitigation strategies Represents RQA on relevant governance committees (e.g. QOC) Proactively communicates with senior leadership on audit outcomes & represents quality assurance audit oversight trends at major enterprise-wide committees Here Is What You Need (Minimum Requirements) BS (or equivalent), preferably in pharmaceutical or natural sciences, or equivalent Extensive relevant experience (proven leadership and robust experience in auditing or quality management including quality control/assurance, manufacturing, regulatory affairs, or product development) Experience in a management role preferred (or equivalent) with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities Highly experienced and has proven ability in enterprise leadership and execution of business practices Adept in strategic resource management Demonstrates broad knowledge of clinical development processes and impact of GCP processes on the overall clinical development system and associated risk Demonstrates expert knowledge of ICH GCP, applicable global regulations, and process/program regulatory and inspectional trends; Demonstrates advanced critical thinking capabilities (e.g. synthesize key insights and complex problems clearly and precisely, infer important implications and consequences, use deductive reasoning consistently and with ease to drive effective solutions or programs) Ability to drive continuous improvement strategy and operational improvement opportunities Experience evaluating and understanding quality standards or their application Ability to identify risks, propose effective mitigations and escalate as needed Has proven leadership capabilities and can represent Pfizer in industry conferences and with stakeholders Able to engage correct path for stakeholder engagement Purpose Breakthroughs that change patients' lives At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. Digital Transformation Strategy One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience. Flexibility We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation Equal Employment Opportunity We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees. DisAbility Confident We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here Quality Assurance and Control