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Manager QualityAssurance

Pfizer


Location:
McPherson, KS 67460
Date:
11/02/2017
2017-11-022017-12-18
Pfizer
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Job Details

**ROLE SUMMARY**



Reporting to the Director of Compliance, the Change Control Manager is responsible for the establishment and execution of the Change Control strategy to ensure robust change management processes and ensure that changes align with local and corporate procedures. This position will also be responsible for ensuring Change Control practices are compliant with the most current applicable regulatory requirement, Pfizer Quality Standards and are current with industry standards.







**ROLE RESPONSIBILITIES**







+ Process Owner for cGMP Change Control



+ Direct supervision of Change Control personnel



+ Oversee Quality input and review of Change Control Requests



+ Leads Change Control Review Board (CRB)



+ Functional Lead for change control related to Shutdown activities



+ Performs any required investigations relating incidents within the Change Control Process



+ SME for customer audits, internal audits, and regulatory Inspections regarding cGMP change control process







**QUALIFICATIONS**







+ Bachelor Degree or 10 years applicable experience in Quality functions in the Device or Bio-Pharma industry



+ Scientific or technical experience is preferred but others may be considered



+ Experience working in the bio-pharmaceutical industry



+ Quality compliance, audit, and investigation skills



+ Management skills and experience



+ Able to take a systems approach and to understand the interaction between Quality Systems



+ Proven Project management experience



+ Proven ability to work closely with a variety of Management Levels







**PHYSICAL/MENTAL REQUIREMENTS**



Office environment with some production floor interaction (minimal)







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



Minimal travel







**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.







**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.







+ **Last Date to apply: November 23, 2017**



+ **This job is a Hospira Exempt US Grade: 18**



+ **RELOCATION WILL BE PROVIDED**







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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