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Manager, Auditor

4 months ago

Stone Cross East Sussex, United Kingdom Pfizer Full time

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.

What You Will Achieve

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. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. 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. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.

It is your problem solving skills that will make Pfizer ready to achieve new milestones and help patients across the globe.

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

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

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 - Field Based

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.

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

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. 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

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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