Sr Manager, GCP Auditor

ROLE SUMMARY 

The Senior 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 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 GCP 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 

• Coaches colleagues – leads training for routine and non-routine site and process audits 

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

• Independently/with minimal supervision demonstrates leadership by providing clients with influence and recommendations to meet changing GCP business needs 

QUALIFICATIONS

MUST-HAVE:

• BS (or equivalent), preferably in pharmaceutical or natural sciences, or equivalent

• 7+ years of experience, including 2 levels; operations and auditing required

• Lead audit teams (2-6 ppl per team) 

• 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 

• 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  

• Acts as a specialist in specific therapeutic area or specialty (e.g. gene therapy) and/or audit topic (e.g. data management, remote trial methodology etc.) 

• Candidate 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.

NICE-TO-HAVE: 

• 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 

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS