ROLE SUMMARY

The Manager, Auditor is responsible for the delivery and execution of the global Quality Assurance (QA) program audit activities on assigned GCP portfolio/programs/entities. This role is responsible for GCP Oversight and for assuring the compliance of projects, products and programs with Pfizer Standard Operating Procedures (SOPs), policies, and all applicable worldwide regulations and guidelines (e.g. US FDA, EU Directives, ICH, and National regulations). 

ROLE RESPONSIBILITIES 

• Assesses compliance of GCP clinical trial sites and processes against ICH GCP and applicable global regulations
• Independently conducts more complex routine/non-routine investigator site audits, support process audits, and manage/lead with minimum oversight
• May engage with more complex audits or serve as a reviewer of low complexity, outsourced audits
• Supports and executes on quality programs related to functional areas, specific vendor entities and/or assessments
• Has GCP working knowledge and is called upon to resolve issues based on knowledge of relevant SOPs (Standard Operating Procedures), GCP regulations and guidelines, as well as local regulations
• Works with RQA colleagues on cross GCP audit plans as required. Collaborates with colleagues across RQA and auditees from different functional lines and/or vendors within Pfizer.
• Provides clients with recommendations and influences to meet the changing business need with support from Manager

BASIC QUALIFICATIONS

• BS (or equivalent), preferably in pharmaceutical or natural sciences, or equivalent
• Demonstrates knowledge of ICH GCP and global regulations 
• Demonstrates solid working knowledge of business concepts and quality operations 
• Ability to think critically to identify and assess areas of greatest risk and develop a strategic approach to audit based on compliance and business knowledge 
• Understands quality and auditing frameworks and application 
• Exhibits proficient organizational and project management skills 
• Demonstrates technical writing skills
• Ability to identify trends within data and apply insights to make recommendations 
• Understands Regulatory environment with the ability to interpret and apply regulations 
• Actively identifies areas to assess for greater risk to support senior auditor positions in driving outcomes
• Ability to synthesize information and draw conclusions 
• Experience evaluating and understanding quality standards or their application 
• Suggests new audit techniques and new controls 
• Acts as SME in specific specialty (e.g. gene therapy, non-interventional studies, etc.) 

PREFERRED QUALIFICATIONS

• Able to demonstrate extensive experience (operational or auditing preferred)
• Knowledge of core regulations governing the auditing space (FDA, Global Regulations, etc.) 
• Exhibits working knowledge of data analytics and interpretation capabilities
• A Manager must have at least one specialized knowledge area or two minor specializations 

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• The travel requirement may be approx. 40%   

Work Location Assignment: Remote

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!