Manager, Auditor

3 weeks ago

Stone Cross East Sussex, United Kingdom Workingmums Full time

Why Patients Need You

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



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