Senior Manager, GCP Auditor, Research, Development & Supply (RDS)

Role Summary

The Senior Manager, GCP Auditor, Research, Development & Supply (RDS) 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 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 (domestic and international) to around 15-20%; though this is flexible

Make a difference today! All suitable candidates should apply through the link with CV provided. We are looking forward to hearing from you!

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

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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

Additional Information 

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

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

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How to apply 

• Make a difference today, all suitable candidates should apply with CV below.  We are looking forward to hearing from you! 

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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!

Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

 

 

Finance & Accounting