Audit Manager, Research, Development & Supply

Employer
Pfizer
Location
Peapack, New Jersey
Posted
Jun 15, 2022
Ref
4857256
Required Education
Bachelors Degree
Position Type
Full time

The Audit Manager, Research, Development and Supply will be part of Pfizer Corporate Audit’s internal team that provides “third line of defense” assurance in regulated areas across the enterprise. They will use their audit expertise and knowledge of regulated areas to plan and execute best in class audit assurance.

The Audit Manager is responsible for conducting independent audits and risk oversight activities in Good Clinical Practice (GCP), Pharmacovigilance (PV) or Good Manufacturing Practice (GMP). These audits provide an independent assessment of the design and operating effectiveness of controls and compliance with appropriate regulations, internal policies and procedures and good business practices. Audit Manager also participates on strategic and operations teams within Corporate Audit.

ROLE RESPONSIBILITIES

Audits

  • Collaborate 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
  • Based on the audit plan, develop testing strategies for assigned areas
  • Conduct walkthroughs and execute test of controls for assigned areas
  • Manage the appropriate prioritization of work to execute an effective work plan for audit/project work and keep Audit Director regularly apprised of status and issues
  • Interpret the analytics results to draw conclusions on the controls’ effectiveness, or to open lines of inquiry, as appropriate
  • Identify and discuss preliminary issues with auditees
  • Present the results of audits to senior site and division management, including practical recommendations to address identified risks, requiring strong negotiation and influence skills.
  • Document audit work and prepare formal written reports setting forth recommendations for local, division and Corporate management to strengthen and improve operations
  • Conducts other oversight activities (e.g., Assessments, due diligence, 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, such as process improvements, audit tools implementations, etc.
  • Serves on Corporate Audit departmental committees/teams as necessary, such as Quality Assessment Review, Risk Assessment, Audit Scheduling, etc.
  • Assists in the development/updating of Corporate Audit departmental standard operating and administrative procedures
  • 5erves as a resource on compliance matters
  • Attends conferences, training courses, seminars, etc. on subjects relevant to the areas of responsibility

BASIC QUALIFICATIONS

  • Bachelor's degree is required in a scientific discipline is strongly preferred (e.g. Biology, Chemistry, Engineering, Nursing, Medical Technology, Pharmacy)
  • 5+ years of professional experience in a Pharma regulated area (e.g. R&D, Manufacturing, Development)
  • 3+ years experience in a quality related compliance discipline
  • 2+ years experience conducting audits domestically and/or internationally
  • A thorough understanding of GMP, GCP and/or PV global regulations and demonstrated subject matter expertise in one area
  • Demonstrated ability to apply knowledge of regulations, policies and standards to assess compliance
  • Experience working in dynamic complex business models (e.g. outsourcing and partnerships)
  • Ability to assess systems and processes in a highly systematic manner and make conclusions based on sound judgment and experience in order to identify gaps and potential risk
  • Excellent written and verbal communication and presentation skills
  • 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.
  • 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%

PREFERRED QUALIFICATIONS

  • Masters in Business or Life Sciences discipline
  • Relevant experience in clinical Studies, manufacturing, safety reporting and project management
  • Proven leadership skills
  • IT experience , e.g. operations, security, validation or development/programming

Other job duties

Last day to apply: July 1, 2022


Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Finance & Accounting

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