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Quality Assurance, Senior Manager

4 months ago

New York, New York, United States Pfizer Full time

ROLE SUMMARY
Regulatory Quality Assurance (RQA) is an independent Quality audit function within the Compliance division, accountable to identify risks and non- compliance associated with Pfizer's GxP regulated operations.
The Sr. Manager, Auditor is responsible for the delivery and execution of the global Quality Assurance (QA) program audit activities on assigned GxP enterprise processes that span GCP, PV, Regulatory, Medical or are conducted at the Pfizer Country Offices. 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

  • Independently conduct wide range (non-routine) complex audits (minimal to no oversight - as needed).
  • Execute audit strategy and lead process audits.
  • Act as a reviewer of audit reports from outsourced or routine audits.
  • Assess audit plans and quality metrics to identify potential areas of risk.
  • Actively support regulatory inspections as needed.
  • Identify and drive process improvements.
  • Deliver awareness sessions with oversight by manager on various GxP topics internally and externally.
  • Drive 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 engage in discussions to determine impact of changing needs of the regulatory environment.
  • Work with RQA colleagues on cross GxP audit plans as required.
  • Coach colleagues - lead training for routine and non-routine site and process audits.
  • Advise business representatives (e.g. BPOs) on outcomes of complex audits and provides input to process improvement activities.
  • Independently/with minimal supervision demonstrate leadership by providing clients with influence and recommendations to meet changing GxP business needs.


Must Have:

  • Bachelors degree or equivalent.
  • 7+ years of experience including 2 levels; operations and auditing.
  • 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.
  • 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.
  • 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:

  • Lead audit teams (2-6 ppl per team).
  • Ability to work with ambiguity and adapt plan when needed.
  • 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.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • The travel requirement may be approx. 40% (10% GLP), International Travel


Other Job Details:

  • Last Date to Apply for Job: May 28, 2024
  • Additional Location Information: New York, NY; Canada - Remote; Latin - America; North America - Remote
  • Work Location Assignment: Remote - Field Based


The annual base salary for this position ranges from $117,300.00 to $195, 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 | ). 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
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