Senior Manager, Auditor

Recruiter
Pfizer
Location
Tadworth
Salary
Negotiable
Posted
05 May 2021
Closes
19 May 2021
Ref
4812911
Hours
Full Time
Contract Type
Permanent

 

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 Senior Manager, your advanced knowledge of the principles and concepts in the discipline and comprehensive knowledge of other disciplines will enable you to lead complex projects across the division. Your ability to develop and manage plans will facilitate in achieving objectives, interpreting internal and external business challenges and recommending best practices for improvements. While managing complex project environments, you will be able to anticipate and troubleshoot roadblocks and influence teams to achieve targets for the division.

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


Role Summary
The Senior Manager, Auditor is responsible for the delivery and execution of the global Quality Assurance (QA) program audit activities on assigned GxP portfolio/programs/entities. This role is responsible for GxP 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 wide range of routine/(non-routine) complex investigator site audits (minimal to no oversight - as needed)
  • Executes audit strategy, leads/supports process audits, and may support Due Diligence assessments
  • Acts as a reviewer of audit reports from outsourced or routine audits
  • Assesses audit plans and quality metrics to identify potential areas of risk
  • Actively supports regulatory inspections as needed
  • Identifies and drives process improvements
  • Delivers awareness sessions with oversight by manager on various GxP topics internally and externally
  • Drives interactions with QA colleagues at other Pfizer locations to ensure consistency in application of QA strategy and to promote standardization of auditing approach within QA
  • Actively engages in discussions to determine impact of changing needs of the regulatory environment
  • Works with RQA colleagues on cross GxP audit plans as required

 

Basic Qualifications

  • BS (or equivalent), preferably in pharmaceutical or natural sciences, or equivalent
  • Demonstrates in-depth knowledge of ICH GCP and applicable global regulations
  • Demonstrates comprehensive working knowledge of business concepts and quality operations
  • Displays critical thinking expertise, with ability to define and implement a strategic approach to audit based on compliance and business knowledge
  • Strong use of quality and auditing frameworks and application
  • Routinely suggests new audit techniques and approaches, and operationalizes to improve the audit system
  • Ability to identify trends within data and apply insights to make recommendations and decisions
  • Ability to bring recommendations to stakeholders for discussion and input
  • Actively leads and progresses efforts to deliver operational improvements
  • Exhibits good project management capabilities


Preferred Qualifications

  • Significant experience (2 levels; operations and auditing required)
  • Lead audit teams (2-6 ppl per team)
  • Demonstrates stakeholder and conflict management (communications, relationship management)
  • Negotiates needs & acquires feedback on audit outcome
  • Preferred experience in audits with a background in GCP, PV, GLP, Process or other related quality areas
  • Expertise in 1+ major areas (Doc, PCO, Disease Area, etc.); and 2+ minor specializations OR 2+ major and 1+ minor
  • Ability to function autonomously in a matrix model and in a team environment

 

Non-Standard Work Schedule, Travel or Environment Requirements

  • The travel requirement may be approx. 40% (10% GLP)

 

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