Manager Quality Assurance

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ROLE SUMMARY

The candidate will partner with key business lines to provide QA GMP guidance and support of clinical API manufacturing and testing operations. As a member of PSSM QO lead the implementation of new initiatives and goals within PSQA, PSSM QO, and with business line partners (e.g. manufacturing, testing, etc.), to drive consistency,

efficiency and compliance.

This position requires an understanding of quality systems as they relate to the manufacturing and testing of API.

The candidate should possess knowledge of cGMPs, and Pfizer quality processes and procedures for specific quality tasks and have a knowledge of scientific principles.

Business travel will be required to other Pfizer locations as well as to contractors/suppliers/external laboratories used by Pfizer.

This position does not include the management of direct reports.

ROLE RESPONSIBILITIES
  • Perform disposition of clinical API, API intermediates, starting materials, raw materials, reagents in support of Groton API Manufacturing operations.
  • Provide QA guidance and support to new initiatives and technologies within QA and with PSSM QO business line partners (e.g. API Manufacturing, GMP Analytics, ARD).
  • Provide sound QA guidance to investigations of product/facility deviations.
  • Use risk-management tools to assess quality issues occurring during manufacturing/testing activities.
  • Contribute to the development and compliance of quality and business line partner procedures.
  • Maintain awareness of current pharmaceutical compliance trends and utilize information to support system changes, enhance the internal audit process and prepare for inspections.
  • Effectively collaborate with functional leadership to ensure local processes and quality systems are in alignment with global initiatives.
  • Continuously assess performance within area of responsibility against the Quality System Elements
  • Identify opportunities and facilitate improvement solutions to ensure consistency, compliance and best practice sharing.


QUALIFICATIONS
  • Bachelor's Degree (B.S.), preference in Industrial Pharmacy, Pharmaceutical Science, Chemistry, Engineering, or Biology.
  • 5-10 years of relevant work experience in a scientific/pharmaceutical environment required.
  • Must possess strong written and oral communication skills as well as strong computer skills. Must exhibit strong interpersonal skills and the ability to work effectively in teams


ORGANIZATIONAL RELATIONSHIPS

This role is within the global Pharmaceutical Sciences QA group. Primary relationships with quality assurance team and the Pfizer business lines supported. Relationships with vendors (CMO's) and other Pfizer sites across the globe, as applicable.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Business travel will be required to other Pfizer locations as well as to contractors/suppliers/external laboratories used by Pfizer.

OTHER DETAILS
  • Last Date to Apply: October 26, 2021
  • Eligible for Employee Referral Bonus


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

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