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Global Quality Operations Device Combination Products leader

Pfizer


Location:
Peapack and Gladstone, NJ
Date:
01/25/2018
2018-01-252018-02-25
Pfizer
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Job Details

ROLE SUMMARY



The Quality Device Combination Products leader is responsible for ensuring that evolving global Agency regulations and expectations governing Combination Products are identified, translated to in Pfizer Quality Standards and to ensure appropriate Systems and Controls are implemented at both manufacturing sites and across center functions.







The incumbent will be responsible for working with the inspection readiness team to ensure that Pfizer's global manufacturing operations which are subject to cGMP and product approval inspections by FDA and/or other national/international regulatory agencies have appropriate systems and controls in place associated with combination and medical device products.







ROLE RESPONSIBILITIES



**Own the GQO elements for the PGS combination products program. Member of the Pfizer Combination products Project Management leadership and SME work-streams.**







+ **Provide support and leadership to core teams working to ensure Pan Pfizer cross functional technical alignment within focus area activities, between focus areas and with combination products steering team.**



+ **Working with Inspection Readiness team to participate in Inspection readiness activities directly in support of the team working with combination products**



+ **As an SME, partner with OpU QOLs to develop a prioritized model of support for sites supplying combination products.**



+ **Partner with GQO Quality Systems team to ensure PQS alignment versus any new regulations or inspectional observations is performed and necessary PQS updates are identified.**



+ **Lead a program to identify and follow up with impacted sites on key regulatory inspection observations, to establish if similar gaps exist and, if so, to track the closure of these gaps to completion.** **Provide support, where required, to the Regulatory Inspection Response Manager**







QUALIFICATIONS







+ **10 years' Experience in operational risk and compliance management, including experience in device / combination products biopharmaceutical manufacturing and in leading high performing cross functional teams; technical and practical knowledge combinations products and device manufacturing is essential.**



+ **Broad knowledge of relevant regulatory cGMP audit frameworks that apply to combination products , devices and pharmaceutical operations, in-depth knowledge of relevant regulations, trends and expectations and familiar with other GXP concepts and global regulations (FDA, EU, TGA, PIC/S, etc.)**



+ **Demonstrated experience interpreting and applying Quality regulations, regulatory guidance and relevant codes to recommend changes to enhance compliance programs**



+ **Experience leading teams that have successfully implemented quality systems that support facility, product design, development, production, distribution.**



+ **Evidence of designing, implementing and maintaining technical programs informed by current industry/regulatory knowledge.**



+ **Applies business and technical acumen - Experience in designing, implementing and maintaining effective risk management programs informed by current industry/regulatory knowledge**



+ **Motivates and leads change - Demonstrated experience leading team(s) of senior technical professionals, through change, developing industry leading technical programs across multiple sites and geographies/regulatory frameworks and demonstrated success in leading teams to continuous performance improvement.**



+ **Must be an effective verbal and written communicator (e.g. of impact of risk, need for change), active networker (inside and outside the company) and able to influence at all levels of the organization; evidence of influencing site leaders/site quality leaders/other functional leaders to implement program changes to enhance quality management systems.**



+ **Must be comfortable interacting and influencing with confidence across group and divisions (Regulatory, Safety, Technical Services etc.) to develop necessary work processes.**



+ **Undergraduate degree in science e.g. biological sciences or chemistry, engineering, or equivalent.**



+ **Postgraduate professional qualifications in one or more relevant disciplines such as science, business administration desirable.**



+ **Membership in at least one relevant professional body, ideally with a formal continuous professional development requirement.**







NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS



**Expected to travel approx. 20% of the time but may vary and be higher initially**







**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.







**Other Job Details:**







+ **Last Date to Apply for Job: February 7, 2018**







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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