Senior Manager, Corporate Audit

Pfizer; Ireland; On-site; EUR 120,000 - 150,000; Full time

Job summary

Pfizer is seeking a Senior Manager - GCP Auditor to plan, lead and perform independent audits ensuring compliance with GCP regulations and internal standards. The role interfaces with business units and recommends oversight approaches for risk mitigation.

Requirements include a biology/health-related degree (advanced degree preferred) with 10+ years of GCP operational experience and 5+ years in GCP quality compliance, plus strong analytical and communication skills. Travel may be required.

Qualifications

• Bachelor's degree in Biology, Chemistry, Nursing, Medical Technology, Pharmacy, or health (advanced degree preferred).
• Ten or more years of relevant GCP international operational experience in clinical development.
• Five years' experience in GCP quality related compliance discipline.
• Thorough understanding of ICH GCP and applicable global & local regulations/guidance for clinical development.
• Experience in GCP risk assessment and/or analysis is strongly preferred.
• Ability to assess systems and processes in a systematic manner and identify gaps and risks.
• Strong analytical skills to digest and interpret complex data.
• Excellent written and verbal communication and presentation skills.

Responsibilities

• Plan, lead and conduct GCP independent audits and risk oversight activities.
• Provide audit findings with practical recommendations to management.
• Develop customized audit plans and data-analytics where applicable.
• Collaborate with Audit Director and Analytics/Innovation teams to support controls testing.
• Maintain awareness of changing regulatory and business needs and participate in special projects.

Skills

Leadership

Project management

Communication

Negotiation

Analytical skills

GCP knowledge

Risk assessment

Education

Bachelor's degree

Advanced degree preferred

Job description

Role Summary

The Senior Manager - GCP Auditor is responsible for planning, leading and conducting Good Clinical Practice (GCP) independent audits and risk oversight activities. These audits/activities provide an independent assessment of the design and operating effectiveness of controls and compliance with appropriate GCP regulations, industry standards, internal policies and procedures and good business practices. Additionally, this individual interfaces with business representatives and makes recommendations on oversight approaches for risk mitigation.

Role Responsibilities

Audits

Provides fact-based input into the risk assessment of audit targets and leads/conducts scheduled audits in accordance with Corporate Audit processes. Analyzes risk information applying critical thinking and demonstrates high level of learning agility. Adapts audit methodologies across a broad set of risks to develop customized audit plans. Collaborates with the Audit Director and the Analytics and Innovation team to develop an audit plan, including data analytics where applicable, to support controls testing as appropriate. Manages the appropriate prioritization of work to execute an effective work plan for audit/project work and keeps Audit Director regularly apprised of status and issues. Analyzes large data sets to identify potential risks and discrepancies. Provides clear and concise verbal and written communication of audit findings and to senior site and division management, including practical recommendations to address identified risks, requiring strong negotiation and influence skills. Documents audit work and prepares formal written reports setting forth recommendations for local, division and corporate management to strengthen and improve operations. Conducts or supports other oversight activities (e.g., Assessments, compliance investigations) as assigned. Identifies ways to improve audit processes to ensure appropriate assessments of controls in an evolving business model.

Analysis

• Recommends approaches for oversight activities to mitigate risks across the assigned business line.
• Identifies ways to improve oversight and assessment processes.

Relationship Management

• Works within functional area to ensure consistency in approach and to minimize gaps and redundancies in activities.
• Cultivates strong relationships within Corporate Audit to achieve an effective oversight program.
• Uses compliance and business intelligence to forge relationships critical to a comprehensive oversight program.

Other Activities

• Maintains high level of awareness of changing needs of the business, industry trends, competitive activities, and regulatory environment.
• Takes on special projects at the request of management.
• Serves on Corporate Audit departmental committees/teams, as necessary.
• Assists in the development/updating of Corporate Audit departmental standard operating and administrative procedures.
• Serves as a resource on GCP compliance matters for their area of subject matter expertise.

Skills, Qualifications and Experience

Bachelor's degree, preferably in an area such as Biology, Chemistry, Nursing, Medical Technology, Pharmacy, or health. Advanced degree preferred.

Ten or more years of relevant GCP International operational experience in clinical development required.

Five years' experience in GCP quality related compliance discipline.

A thorough understanding and extensive knowledge of ICH GCP and applicable global & local regulations/guidance for clinical development.

Previous experience in GCP risk assessment and/or analysis strongly preferred.

Demonstrated ability to apply knowledge of regulations, policies and standards to assess compliance.

Ability to assess systems and processes in a highly systematic manner and make conclusions based on sound judgment and experience to identify gaps and potential risk.

Strong analytical skills with the ability to digest and interpret complex data.

Ability to rapidly comprehend Pfizer organization and agility in maneuvering across the organization.

Experience working in dynamic complex business models (e.g., outsourcing and partnerships)

Strong strategic thinking capability and decision-making skills

Demonstrated excellent project management skills; able to manage multiple projects and demanding timelines

Proven leadership skills

Excellent written and verbal communication and presentation skills to convey audit findings and recommendations effectively.

Excellent interpersonal and negotiation skills, with a demonstrated ability to effectively interact with clients, influence others, identify compliance gaps, and communicate pathways for corrective/preventative actions.

Attention to detail and the ability to work independently as well as collaboratively within a team.

Ability to create a strong collaborative environment working with all levels of management.

A self-starter who holds themselves and others accountable.

Ability to travel (both dom