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Manager QualityAssurance

Pfizer


Location:
Groton, CT
Date:
11/02/2017
2017-11-022017-12-03
Pfizer
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Job Details

**ROLE SUMMARY**







The Manager - Audit/Inspection will be part of the global team within Quality Systems and Compliance team (QS&C) that is responsible for providing support for regulatory and internal compliance activities to support the Medicinal Sciences operations. This position will be based in Groton, Connecticut but will support global activities.







This dynamic Manager will leverage strong and collaborative partnerships with colleagues across Medicinal Science, other Worldwide Research and Development organizations and PGS to lead the management and support of GCP inspections occurring globally. The role will include support for corporate audits and internal audits, as necessary. The Manager will also develop and enhance processes to continuously improve and streamline existing quality processes to support these activities.







**ROLE RESPONSIBILITIES**







+ As an audit/inspection facilitator collaborate with Global Clinical Supply and Pharmaceutical Sciences business lines, PharmSci QA and other groups in Worldwide Research and Development to support regulatory agency inspections, external and corporate audits.



+ Drive continuous improvement in the support model and management of Good Clinical Practices inspection activities for the investigational medicinal product process through robust partnerships with Global Clinical Supply. Streamline compliance and simplify procedural and other requirements to ensure ease of following program requirements.



+ Utilize and share learnings from audits/inspections to advance inspection readiness.



+ Utilize audit/inspection data and regulatory intelligence and partner with business lines to ensure that current regulatory trends and industry hot topics are incorporated into the inspection support program.



+ Audit/inspection commitment tracking and closure.



+ Inspection readiness activities including training colleagues across business lines on regulatory interactions.







**QUALIFICATIONS**







+ Bachelor's Degree (B.S.), most likely in Industrial Pharmacy, Pharmaceutical Science, Chemistry, Engineering, or Biology, or equivalent experience.



+ Must have a minimum of 7 years of relevant work experience in a cGMP pharmaceutical manufacturing or R&D environment. Strong quality mind-set a plus.



+ In depth knowledge of cGMP regulations and the principles/concepts of relevant quality systems and regulatory compliance. Knowledge of GCP a plus.



+ Comprehensive and broad knowledge of quality systems.



+ Demonstrated experience in organizing and conducting continuous improvement projects.



+ Medicinal Sciences (i.e. PSSM, BTxPS, GCS, PEH PS) wide general business understanding.



+ Strong working knowledge of quality culture and compliance and the fundamental regulatory guidelines.







+ Proven leadership, accountability, and demonstrated excellent interpersonal, listening, communication, negotiation, influencing, organizing and problem-solving capabilities.



+ Proven ability to function autonomously in a matrix model and in a team environment.



+ Proven business management capability.



+ Proven ability to think creatively and to execute and manage strategic plans.







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







The position may require infrequent travel to support the audit/inspection activities or business related meetings.







**OTHER INFORMATION**



This position is not relocation eligible.







**EEO Statement**



**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.







**Additional Offer Details:**







+ **Last Date to Apply for Job:** November 14, 2017



+ **Grade:** 12







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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