Manager, Auditor

For more than 170 years, Pfizer has continuously worked to make a difference by delivering innovative therapies that improve the lives of our patients. By building a talented community of colleagues that align with our patient-focused purpose and core values, Pfizer has improved global health and impacted more than 780 million patients around the world.

In 2021, Pfizer expanded its global footprint to Tampa, establishing a strategic powerhouse that brings together multi-disciplinary, professional services including Finance, Accounting, Treasury, Digital, HR Services, Sourcing, Commercial and Project Management into a single, centralized location. With so many diverse and highly-skilled colleagues supporting multiple functions and services across the organization, Pfizer Tampa offers ample opportunity to engage in newer ways of working that enhance, simplify, and transform how we deliver treatments to our patients.

Located in Heights Union, the Pfizer Tampa site offers a modern industrial design, the latest in innovative technology, and close proximity to Downtown with views of the Tampa Riverwalk and access to the Channel district and Bayshore Boulevard. From an onsite fitness center to top floor panoramic balconies and outdoor patio, our activity-based space will provide various ways of working to offer collaboration and flexibility to colleagues. The Pfizer Tampa site has constructed an atmosphere that fosters interaction and prioritizes colleague health and wellness.

Additionally, to achieve breakthroughs that change patients' lives, Pfizer is revolutionizing and evolving how colleagues work today. This year, Pfizer launched a new initiative that we call Log In For Your Day where a majority of colleagues can arrange with their manager to work remotely two or three days a week while still maintaining the ability to collaborate regularly in person at our sites. This flexible working model blends the best of remote work and on-site collaboration to drive greater flexibility, support work-life balance, and promote a vibrant, agile, and innovative culture.

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve
  • You will be a member of Pfizer's dedicated and highly effective quality assurance team. You will conduct audits of third parties/vendors, in particular in the analytical and safety third party laboratories. Your expertise will help in identifying deviations from established standard in the conduct of pre clinical and clinical trials.
  • As an Auditor (Manager), your advanced knowledge of the principles and concepts in the discipline and comprehensive knowledge of other disciplines will enable you to lead complex projects across Regulatory Quality Assurance.
  • It is your problem solving ability that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It
  • Conducts wide range and GxP (Good Practices Quality Guidelines and Regulations) of third parties/vendor audits, (i.e. Routine or Non-Routine, pre-clinical, toxicology sites, etc.) in accordance with RQA (Regulatory Quality Assurance) risk-based processes
  • Assesses compliance of vendors processes against ICH (International Conference of Harmonization), applicable government agency regulations/ guidelines, as well as Pfizer policies, procedures and industry standards; applies comprehensive working knowledge of Quality Assurance, regulations and auditing
  • Conducts RQA audits reports, results to project team personnel and management, and interacts with various teams to ensure corrective actions are taken to bring QA observations to closure as applicable
  • Develops and delivers awareness sessions with minimal supervision on various GCP (Good Clinical Practice)/GCLP (Good Clinical Laboratory Practices)/GLP (Good Laboratory Practices) topics internally and externally
  • Acts as a strong technical resource and is called upon to resolve GCP/GCLP/GLP issues based on knowledge of relevant SOPs (Standard Operating Procedures), GCP, GLP, GCLP regulations and guidelines as well as local regulations
  • Consistently demonstrates expertise in the use of different Pfizer systems
  • Contributes to RQA by undertaking a variety of roles or assignments to further develop internal processes and people
  • Routinely suggests new audit techniques/aids in areas of technical expertise; strong ability to operationalize create ideas proposed; frequently engages new ideas or ways of doing things and influences creative thinking
  • Designs and actively participates in special assignments on various project teams and work streams as determined by RQA management
  • Actively supports regulatory inspections or corporate audit activities
  • Ensures rapid communication of QA issues, including potential misconduct or issues of
  • significant deviation with projects/products to appropriate leaders and colleagues
  • Provides training and mentorship to less experience members of RQA colleagues
  • Exemplifies ability to work in a culturally diverse environment
  • Provides subject matter expertise representing RQA at cross-functional forums and/or projects as endorsed by RQA management

Basic Qualifications
  • Bachelor's degree or equivalent experience
  • 8 or more years of relevant pharmaceutical experience (i.e. analytical laboratory, safety laboratory, clinical and/or nonclinical research,) including at least 2 years previous clinical/nonclinical Quality Assurance experience conducting a broad range of audits

Preferred Qualifications
  • Master's degree
  • Experience in Quality Systems in pharmaceutical, medical device, or combination product industry
  • Knowledge or exposure to and data sciences

Non-Standard Work Schedule, Travel or Environment Requirements
  • Travel Required: Requires approximately 40-60% time for conducting audits (including travel) and attending QA meetings

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