Manager, Auditor
4 weeks ago
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer’s clinical and commercial batches of drugs. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.
As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. It is your problem solving skills that will make Pfizer ready to achieve new milestones and help patients across the globe.
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. 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. BS (or equivalent), preferably in pharmaceutical or natural sciences, or equivalent
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
Experience evaluating and understanding quality standards or their application
Suggests new audit techniques and new controls
Demonstrable 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
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS · The travel requirement may be approx. Work Location Assignment: Remote (UK / EU). 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.
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. We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer iscommitted to celebratingthis,in all itsforms – allowing for us to be as diverse as the patients and communities we serve. 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. Your journey with Pfizer starts here
Quality Assurance and Control Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.
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