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 operational 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,