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Pfizer Sr. Manager, Auditor GCP Vendors in New York, New York

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 be responsible for conducting Quality Assurance audits on GCP/GCLP Vendors supporting Pfizer QA audit strategy.

As a Senior 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 the division. Your ability to develop and manage plans will facilitate in achieving objectives, interpreting internal and external business challenges and recommending best practices for improvements. While managing complex project environments, you will be able to anticipate and troubleshoot roadblocks and influence teams to achieve targets for the division.

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

ROLE SUMMARY

The Senior Manager, Auditor is responsible for the delivery and execution of the global Quality Assurance (QA) program audit activities on assigned GCP Vendors. This role is responsible for assuring the compliance of Vendors with standard processes, regulatory guidelines and laws (e.g. US FDA, EU Directives, ICH, and National regulations), business contracts and work orders, and an assessment of the protection of the rights, safety and well-being of study participants and consumers, as well as data privacy and security.

ROLE RESPONSIBILITIES

  • Assesses compliance of Vendors against applicable government agency GCP and GCLP regulations and guidelines as well as Pfizer policies and procedures

  • Independently conducts/leads more complex routine audits for at least one vendor type (e.g. labs, study conduct), supports non-routine vendor audits and Pfizer process audits as applicable

  • May engage with more complex audits or serve as a reviewer of low complexity, outsourced audits

  • Leads RQA Vendor projects

  • 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 influence to meet the changing business need with support from Manager

QUALIFICATIONS

Must-Have:

  • Bachelor's Degree or equivalent

  • 7+ years' of relevant experience

  • Experience supporting or leading Quality audits and developing/managing remediation plans

  • Relevant pharmaceutical experience including previous clinical Quality Assurance experience conducting a broad range of audits

  • Broad knowledge of relevant regulatory current Good Clinical Practices {part of GxP} audit frameworks that apply to clinical trials, its trends and expectations and familiar with other Good Practice concepts and global regulations

  • Strong verbal and written communication including presentation skills

  • Strong project management skills

  • 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

  • Master's degree

Other Job Details:

  • Last Date to Apply for Job: May 28, 2024

  • Additional Location Information: North America - Remote; North America - Any Pfizer Site

  • Work Location Assignment:Field Based - Remote

The annual base salary for this position ranges from $117,300.00 to $195,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 17.5% 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 applies to the Tampa, FL location only. The salary range provided does not apply to any other United States location or locations 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

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