Manager, Compliance - GCP Auditor

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The Manager, Auditor is responsible for the delivery and execution of the global Quality Assurance (QA) program audit activities on assigned GxP portfolio/programs/entities. This role is responsible for GxP Oversight and for assuring the compliance of projects, products and p rograms with Pfizer Standard Operating Procedures (SOPs), policies, and all applicable worldwide regulations and guidelines (e.g. US FDA, EU Directives, ICH, and National regulations).

Role responsibilities
  • Assess es compliance of GCP clinical trial sites and processes against ICH GCP and applicable global regulations
  • Independently conduct s more complex routine/non - routine investigator site audits, support process audits, and manage/lead with minimum oversigh t
  • May engage with more complex audit s or serve as a review er of low complexity, outsourced audits
  • Support s and execute s on quality programs related to functional areas, specific vendor entities and/or assessments
  • Has GxP working knowledge and is called upon to resolve issues based on knowledge of relevant SOPs (Standard Operating Procedures), GxP regulations and guidelines , as well as local regulations
  • Work s with RQA colleagues on cross GxP audit plans as required
  • Provide s clients with recommendations and influence s to meet the changing business need with support from Manager

Basic qualifications
  • BS degree preferably in pharmaceutical or natural sciences, or equivalent
  • 5+ years of operational or GCP (good clinical practices) auditing experience required
  • Demonstrates k nowledge of ICH GCP and global regulations
  • Demonstrates solid working knowledge of business concepts and quality operations
  • Ability to think critically to identify and assess areas of greatest risk and develop a strategic approach to audit based on compliance and business knowledge
  • Understands quality and auditing frameworks and application
  • Exhibits proficient organizational and project managem ent skills
  • Demonstrates technical writing skills
  • Ability to identify trends within data and apply insights to make recommendations
  • Understands Regulatory environment with the ability to interpret and apply regulations
  • Actively identifies areas to assess f or greater risk to support senior auditor positions in driving outcomes
  • Ability to synthesize information and draw conclusions
  • Experience evaluating and understanding quality standards or their application
  • Suggests new audit techniques and new controls
  • Acts as SME in specific specialty (e.g. gene therapy, non - interventional studies, etc.)

Preferred qualifications
  • • Knowledge of core regulations governing the auditing space (FDA, Global Regulations, etc.)
  • Exhibits working knowledge of data analytics and interpretation capabilities
  • A Manager must have at least one specialized knowledge area or two minor specializations

  • The travel requirement may be approx. 40%

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.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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.

Quality Assurance and Control