Manager, Auditor (GCP)

ROLE SUMMARY
The Manager, Auditor is responsible for the delivery and execution of the global Quality Assurance (QA) program audit activities on assigned GCP portfolio/programs/entities. This role is responsible for GCP Oversight and for assuring the compliance of projects, products and programs 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

• Assesses compliance of GCP clinical trial sites and processes against ICH GCP and applicable global regulations
• Independently conducts more complex routine/non-routine investigator site audits, support process audits, and manage/lead with minimum oversight
• May engage with more complex audits or serve as a reviewer of low complexity, outsourced audits
• Supports and executes on quality programs related to functional areas, specific vendor entities and/or assessments
• Has GCP working knowledge and is called upon to resolve issues based on knowledge of relevant SOPs (Standard Operating Procedures), GCP regulations and guidelines, as well as local regulations
• Works with RQA colleagues on cross GCP audit plans as required
• Provides clients with recommendations and influences to meet the changing business need with support from Manager

BASIC QUALIFICATIONS:

• Bachelors or equivalent
• 5+ years of o perational or auditing experience
• Demonstrates knowledge 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 management 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 for 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
• 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.
• Suggests new audit techniques and new controls

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS:

• The travel requirement may be approx. 40%

ORGANIZATIONAL RELATIONSHIPS:

• Collaborate with colleagues across RQA and auditees from different functional lines and/or vendors within Pfizer.

Other Job Details:

• Last Date to Apply for Job: October 24, 2024
• Additional Location Information: United States - Remote; Latin America - Remote
• Work Location Assignment: Remote

The annual base salary for this position ranges from $93,500.00 to $155,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
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. This position requires permanent work authorization in the United States.
Quality Assurance and Control