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Director, Auditor

Employer
Pfizer
Location
England
Salary
Negotiable
Closing date
5 Mar 2024

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Job Details

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.



ROLE SUMMARY



Regulatory Quality Assurance (RQA) is an independent Quality audit function within the Compliance division, accountable to identify risks and non- compliance associated with Pfizer's GxP regulated operations. The Director, Auditor is responsible for the delivery and execution of the global Quality Assurance (QA) program audit activities on assigned GXP enterprise that span GCP, pharmacovigilance (PV), regulatory and medical programs/entities or are conducted at the Pfizer Country Offices. 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 Pfizer End-to-End processes within the Country Offices or globally against applicable government agency Regulatory and Pharmacovigilance regulations and guidelines as well as Pfizer standards
  • Designs, leads and conducts all audit types including complex and non- routine audits, process audits and high complex/size PCO markets audits
  • Acts as a reviewer of audit reports across all audit types
  • Assesses audit plans and quality metrics to identify potential areas of risk
  • Identifies and drives process improvements
  • Designs, leads and provides oversight for special assignments on various project teams and work streams as determined by QA
  • May provide oversight and/or serve as a Subject Matter Expert in a specific process or discipline (e.g. regulatory, safety) and/or audit area
  • Delivers awareness sessions on various PV and regulatory 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 internally and externally to determine impact of changing needs of the regulatory environment
  • Provides training and mentorship to less experienced members of RQA colleagues
  • Coaches colleagues - leads training for routine and non-routine site and process audits, as well as training for Due Diligence assessments
  • Develops audit strategy/plans for highly complex audits, such as those involving significant compliance issues or external regulatory impact
  • Advises business representatives (e.g. BPOs) on outcomes of complex audits and provides input to process improvement activities
  • Works across RQA senior leadership to identify cross-GxP audit approaches when necessary



QUALIFICATIONS

  • Demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact
  • BS (or equivalent), preferably in pharmaceutical or natural sciences, or equivalent
  • Demonstrates expertise of ICH GCP, EMA Pharmacovigilance Directives and applicable global regulations
  • Demonstrates broad knowledge across PV/REG/Medical processes and potential cross-functional impact of associated risk
  • 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 communicate with and manage stakeholders in leadership positions for escalation and decision making
  • Experience evaluating and understanding quality standards or their application
  • Actively leads and progresses efforts to deliver operational improvements
  • Exhibits good project management capabilities
  • Has domain expertise in 2 or more technical areas
  • Ability to work with ambiguity and adapt plan when needed
  • Uses and interprets qualitative/quantitative data to drive decision making, operationalize recommendations and understand potential impact to other areas of the business
  • Influences Pfizer policies and processes in response to the changing needs of the regulatory environment



PREFERRED QUALIFICATIONS

  • Master's or advanced degree preferred
  • Has extensive 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
  • Provides training/mentorship to other auditors or SMEs
  • Provides structured mentoring/development
  • Provides coaching for auditing needs/specialties




Work Location Assignment: Flexible

Company

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. 

In the UK, we have around 2,400 colleagues across four locations, working within our commercial business, research and development (R&D), manufacturing and distribution operations.

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