1+ months

Manager Quality Assurance

Pfizer
Kalamazoo, MI 49007
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**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.



**ROLE RESPONSIBILITIES**



+ Reviews documents for accuracy and ensure they meet quality documentation requirements. After the review, individual is the final Quality approver for the documentation which includes: exception reports, batch records, SOP's, validation reports, technical transfer reports and change requests.

+ Monitors quality systems and procedure related to the raw material ME process.

+ Identifies requirements for quality agreements, coordinates terms of the agreements, assists with drafting of the document, reviews the finished agreement.

+ Responsible for the evaluation of lots / batches and routine release of lots / batches in LIMS and other applicable systems.

+ Acts as Site Quality Authority on raw material related unplanned incidents. Reviews and approves incidents, verifies that they are conducted and documented according to Pfizer expectations, Places implicated lots on hold in the applicable systems.



**Qualifications**



**Must-Have**



+ Bachelor's degree in Chemistry, Biochemistry, Microbiology or related science and at least 6 years of relevant experience in pharmaceutical quality operations required. Candidates with related advanced science degrees and relevant experience may also be considered as follows: Master's degree with at least 4 years experience or PhD with at least 2 years experience.

+ The Supplier Quality manager must have the ability to effectively communicate through written and oral means. Understand the quality systems and be able to drive consistency between supplier and Pfizer. The person needs to understand the concepts incorporated in Quality Assurance in GMP environment. Must be cable of multi-tasking job tasks through multiple projects.

+ Experience with word-processing, spreadsheet and presentation software (e.g. MS Word, Excel, Access, Microsoft Project and PowerPoint) working in a cross-functional, team environment beneficial. Experience with QTS, SMS, SAP, and gLIMS. Prefer previous experience in supplier quality organization.

+ Experience in a cGMP environment, with a strong working knowledge of a variety of quality systems and processes to drive consistency between the suppliers and Pfizer.

+ Demonstrated proficiency in organizational and project management skills and must be able to balance multiple priorities.



**Nice-to-Have**



+ Experience: Minimum 6 years pharmaceutical experience at a drug product manufacturing site in Quality Assurance role working with deviation and lot release support.

+ Previous experience in supplier quality organization preferred.



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



This is a 1st shift position that may require occasional weekend/evening work supporting external and internal customers.



Other Job Details:



+ **Last Date to Apply for Job: June 24, 2021**

+ Eligible for Relocation Package

+ Eligible for Employee Referral Bonus



**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



\#LI-PFE
Posted: 2021-06-24 Expires: 2021-07-25
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Manager Quality Assurance

Pfizer
Kalamazoo, MI 49007

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