Senior Manager, Corporate Audit

Pfizer; Dublin; On-site; EUR 130,000 - 160,000; Full time

Job summary

Pfizer is seeking a Senior Manager – GCP Auditor to plan, lead and conduct independent GCP audits and risk oversight across clinical development. The role requires strong analytical and communication skills, collaboration with the Audit Director, and the ability to influence management with practical remediation actions.

The successful candidate will manage complex audits, develop data-informed audit plans, and travel up to 30% to domestic and international sites as needed within Pfizer's global

Qualifications

• Bachelor's degree in a health/science field; advanced degree preferred.
• Ten+ years of relevant GCP operational experience in clinical development.
• Five years' experience in GCP quality compliance.

Responsibilities

• Plan, lead and conduct GCP independent audits and risk oversight.
• Analyze risk information and adapt audit methodologies across risks.
• Prepare written reports with recommendations for management.
• Travel up to 30% to locations as required.

Skills

GCP compliance

Audit planning

Data analysis

Communication

Project management

Travel readiness

Education

Bachelor's degree in Biology, Chemistry, Nursing, Medical Technology, Pharmacy, or health

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 domestic and international) up to 30%.
• Travel requirements 30%.
• The closing date for applications is September 20th.

Travel requirements

Travel requirements 30%.

Please note there is no relocation support available for this position.

Additional Information

In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland.

In order to be considered for this position you need to be legally eligible to work in the EU.

Due to the high volume of applications we will be contacting successful candidates only.

Purpose

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. Digital Transformation Strategy One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

Disability Inclusion

Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!

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Finance & Accounting Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.