Manager Auditor - Stone Cross, East Sussex, United Kingdom - Pfizer, Inc.

Description

The GxP Manager, Auditor is responsible for the delivery and execution of the global Quality Assurance (QA) program audit activities on assigned GxP Vendors.

This role is responsible for GxP Oversight and for assuring the compliance of Vendors with Pfizer Standard Operating Procedures (SOPs), policies, and all applicable worldwide regulations and guidelines (e.g.

Assesses compliance of Vendors against applicable government agency GCP, Regulatory and Pharmacovigilance regulations and guidelines as well as Pfizer policies and procedures
Independently conducts/leads more complex routine audits for at least one vendor type (e.g. study conduct, pharmacovigilance service providers), supports non-routine and vendor oversight process audits and manages/leads 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 GxP working knowledge (mainly GVP) and is called upon to resolve issues based on knowledge of relevant SOPs (Standard Operating Procedures), GxP regulations and guidelines (mainly GVP), as well as local regulations
Works with RQA colleagues on cross GxP 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 skill
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.
Acts as an SME within a discipline/specific vendor program (e.g. labs, data management, etc.)
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.

Work Location Assignment:
Remote
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.

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 is committed to celebrating this, in all its forms - 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
#