Senior Manager Auditor

1 month ago

United Kingdom Workingmums Full time

Job Description: Senior Manager Auditor

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. 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.

You will be responsible for the delivery and execution of the global Quality Assurance (QA) audit activities on assigned GxP enterprise processes that span Pharmacovigilance (PV), Regulatory, Medical 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).

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

How You Will Achieve It

  • Independently conduct wide range (non-routine) complex audits (minimal to no oversight - as needed)

  • Execute audit strategy and lead process audits.

  • Act as a reviewer of audit reports from outsourced or routine audits

  • Assess audit plans and quality metrics to identify potential areas of risk.

  • Actively support regulatory inspections as needed.

  • Identify and drive process improvements.

  • Deliver awareness sessions with oversight by manager on various GxP topics internally and externally.

  • Drive 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 engage in discussions to determine impact of changing needs of the regulatory environment.

  • Work with RQA colleagues on cross GxP audit plans as required.

  • Coach colleagues - lead training for routine and non-routine site and process audits

  • Advise business representatives (e.g., BPOs) on outcomes of complex audits and provides input to process improvement activities.

  • Independently/with minimal supervision demonstrate leadership by providing clients with influence and recommendations to meet changing GxP business needs.

Qualifications

Must-Have

  • Demonstrates comprehensive working knowledge of business concepts and quality operations.

  • Displays critical thinking expertise, able 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.

  • Has domain expertise in 2 or more technical areas

  • Ability to work with ambiguity and adapt plan when needed.

  • Experience evaluating and understanding quality standards or their application.

  • Uses and interprets qualitative/quantitative data to drive decision making, operationalize recommendations and understand potential impact to other areas of the business.

Nice-to-Have

  • Expert knowledge and experience in a similar role (2 levels; operations and auditing required)

  • Lead audit teams

  • Demonstrates stakeholder and conflict management (communications, relationship management)

  • Negotiate needs & acquires feedback on audit outcome.

  • Preferred experience in audits with a background in PV, Regulatory, Medical, Process or other related quality areas.

  • Function autonomously in a matrix model and in a team environment

  • Provides training/mentorship to other auditors or SMEs.



Work Location Assignment: Remote (UK or EU)

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