Senior Manager, Corporate Audit

Pfizer, S.A. de C.V; Dublin; Hybrid; EUR 110,000 - 180,000; Full time

Job summary

Pfizer is seeking a Senior Manager – GCP Auditor to plan, lead and conduct independent GCP audits and risk oversight. This role interfaces with business representatives to recommend oversight approaches for risk mitigation.

The position requires extensive GCP experience, strong regulatory knowledge, and proven leadership to drive audits across complex clinical development programs. Based in Ireland, it offers broad impact and collaborative global opportunities.

Qualifications

• Bachelor's degree in Biology, Chemistry, Nursing, Medical Technology, Pharmacy or health.
• Ten+ years of relevant GCP international operational experience in clinical development.
• Five years' experience in GCP quality-related compliance.
• Strong knowledge of ICH GCP and global/local regulations.
• Experience in GCP risk assessment or analysis is preferred.
• Ability to assess systems and processes and identify gaps and risks.
• Strong analytical and communication skills for presenting findings.

Responsibilities

• Plan, lead and conduct GCP independent audits and risk oversight activities.
• Provide inputs for audit targets and develop customized audit plans.
• Communicate audit findings and practical recommendations to management.
• Conduct or support other oversight activities and update procedures as needed.
• Manage multiple projects and maintain alignment with corporate audit.

Skills

GCP auditing

GCP quality compliance

ICH GCP knowledge

Regulatory knowledge

Data analytics

Risk assessment

Project management

Leadership

Communication

Negotiation

Education

Bachelor's degree in Life Sciences

Advanced degree preferred

Job description

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

At Pfizer, our financial and operational experts shape our path to greatness. Our Finance team ensures our enterprise thrives with unwavering commitment and meticulous attention to detail while our Global Business Services team turns fragmented, complex, and intricate operational services into seamlessly centralized, simplified, and standardized systems.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

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

1. Recommends approaches for oversight activities to mitigate risks across the assigned business line.

2. Identifies ways to improve oversight and assessment processes.

Relationship Management

1. Works within functional area to ensure consistency in approach and to minimize gaps and redundancies in activities.

2. Cultivates strong relationships within Corporate Audit to achieve an effective oversight program.

3. Uses compliance and business intelligence to forge relationships critical to a comprehensive oversight program.

Other Activities

1. Maintains high level of awareness of changing needs of the business, industry trends, competitive activities, and regulatory environment.

2. Takes on special projects at the request of management.

3. Serves on Corporate Audit departmental committees/teams, as necessary.

4. Assists in the development/updating of Corporate Audit departmental standard operating and administrative procedures.

5. 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