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Senior Manager, Auditor (GCP)

Employer
Pfizer
Location
Tampa, Florida
Start date
Aug 9, 2022

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Discipline
Administration, Accounting
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
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Job Details

ROLE SUMMARY

The Senior 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 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 wide range of routine/(non-routine) complex investigator site audits (minimal to no oversight - as needed)
  • Executes audit strategy, leads/supports process audits, and may support Due Diligence assessments
  • Acts as a reviewer of audit reports from outsourced or routine audits
  • Assesses audit plans and quality metrics to identify potential areas of risk
  • Actively supports regulatory inspections as needed
  • Identifies and drives process improvements
  • Delivers awareness sessions with oversight by manager on various GxP topics internally and externally
  • Drives interactions with QA colleagues at other Pfizer locations to ensure consistency in application of QA strategy and to promote standardization of auditing approach within QA
  • Actively engages in discussions to determine impact of changing needs of the regulatory environment
  • Works with RQA colleagues on cross GxP audit plans as required
  • Coaches colleagues – leads training for routine and non-routine site and process audits
  • Advises business representatives (e.g. BPOs) on outcomes of complex audits and provides input to process improvement activities
  • Independently/with minimal supervision demonstrates leadership by providing clients with influence and recommendations to meet changing GxP business needs
  • Lead audit teams (2-6 ppl per team)

QUALIFICATIONS

Must Have:

  • BS (or equivalent), preferably in pharmaceutical or natural sciences, or equivalent
  • Has 7+ years of experience (2 levels; operations and auditing required)
  • Demonstrates in-depth knowledge of ICH GCP and applicable global regulations
  • Demonstrates comprehensive working knowledge of business concepts and quality operations
  • Displays critical thinking expertise, with ability to define and implement a strategic approach to audit based on compliance and business knowledge
  • Strong use of quality and auditing frameworks and application
  • Routinely suggests new audit techniques and approaches, and operationalizes to improve the audit system
  • Ability to identify trends within data and apply insights to make recommendations and decisions
  • Ability to bring recommendations to stakeholders for discussion and input
  • Actively leads and progresses efforts to deliver operational improvements
  • Exhibits good project management capabilities
  • Has domain expertise in 2 or more technical areas
  • Ability to work with ambiguity and adapt plan when needed
  • Experience evaluating and understanding quality standards or their application
  • Uses and interprets qualitative/quantitative data to drive decision making, operationalize recommendations and understand potential impact to other areas of the business
  • Acts as a specialist in specific therapeutic area or specialty (e.g. gene therapy) and/or audit topic (e.g. data management, remote trial methodology etc.
  • Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Nice to Have:

  • Demonstrates stakeholder and conflict management (communications, relationship management)
  • Negotiates needs & acquires feedback on audit outcome
  • Preferred experience in audits with a background in GCP, PV, GLP, Process or other related quality areas
  • Expertise in 1+ major areas (Doc, PCO, Disease Area, etc.); and 2+ minor specializations OR 2+ major and 1+ minor
  • Ability to function autonomously in a matrix model and in a team environment
  • Provides training/mentorship to other auditors or SMEs

ORGANIZATIONAL RELATIONSHIPS

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

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • The travel requirement may be approx. 40% Travel

Other Job Details:

  • Last Date to Apply for Job: August 22, 2022
  • Additional Location Information: Tampa, FL; United States - Remote; North America - Any Pfizer Site
  • Work Location Assignment:Flexible

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

Company

Join world-class scientists and leaders who are dedicated to bringing therapies that will significantly improve patients' lives.

As one of the world's premier innovative biopharmaceutical companies, we're driven to discover the cure --driven to significantly improve the lives of everyone...everywhere. If you're similarly driven, you'll find there's no better place to begin --and continue --your career than at Pfizer.

Science is the foundation of our company.  This is why it's no surprise that the most driven scientists in the world choose to carry out their life's passion at Pfizer.  We arm them with the resources, technology, and facilities they need to solve some of the world’s most complex health challenges. This combination empowers our scientists with expertise in vaccines, small-molecule medicines, biotherapeutics amongst many others, to collaborate on breakthrough science, including the world's first mRNA-Based Covid19 vaccine.  Our colleagues advance science and technologies into the therapies that matter most.

Join us and you'll partner with colleagues of diverse backgrounds and abilities who contribute to all aspects of what we do. Great things happen when people come together with one shared goal. If you're driven to discover the cure- ensure it has the latest technology to make it a reality or help improve the lives of others- join those who are similarly driven at Pfizer. The future of medicine is happening here.

Visit www.pfizer.com and connect with us.

 

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Find Us
Website
Phone
(212) 733-2323
Location
235 East 42nd Street
New York, NY 10017
United States
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