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Quality Remediation Director

Pfizer


Location:
Kansas City, MO
Date:
12/22/2017
2017-12-222018-01-22
Pfizer
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Job Details

**ROLE SUMMARY**







The Remediation Quality Director is focused on strengthening of site Quality systems through leading compliance remediation activities at the Meridian Medical Technologies pharmaceutical manufacturing and product development facilities per the defined Compliance Action Plan. Activities may include oversight, assessments, review and approval of test plans, change requests, protocols and document revisions as required to meet regulatory and cGMP requirements across laboratory, quality assurance, quality culture, investigation, and training remediation focus areas. A large focus of the remediation efforts are focused on meeting cGMPs for Combination Products.



Examples:







+ Lead the development of detailed Quality System Regulation assessments for Combination Products and resulting remediation activity timelines



+ Develop industry leading approaches to Quality System Regulation enhancements



+ Provide oversight and guidance to team execution of the remediation strategy



+ Preview/provide feedback and technical/scientific support on project



+ deliverables, i.e. remediation strategy, plan reports, etc.



+ Monitor and communicate progress to ensure commitment actions are



+ completed according to the defined plan.







Meridian Medical Technology is a world leader in emergency use autoinjectors. These autoinjectors fall under the Combination Product regulations. We are expanding current capabilities to continue to lead the auto-injector industry and seek experienced candidates to maintain and advance novel products to the market through innovation, development, post-market surveillance, and product life-cycle management.







**ROLE RESPONSIBILITIES**







+ Direct up to ten professionals in the execution of Quality remediation activities



+ Responsible for reporting progress on remediation activities to the Program



+ Management Office for presentation to Regulatory Agencies and Pfizer senior management team.



+ Facilitates resolution and appropriate escalation of competing priorities and risks with stakeholders to ensure project success.



+ Engages, influences, and coordinates all functions needed to execute/implement projects.



+ Preview/provide feedback and technical/scientific support on any project deliverables ie. remediation strategy, plan reports, resource needs, etc.



+ Recommends sustainability plan for post-remediation activities.







**QUALIFICATIONS**







+ BS in Business, Engineering or Technical related field required



+ 10+ years' experience in pharmaceutical or similar regulated industry required with prior Quality leadership role; sterile injectable fill/finish Quality experience preferred



+ Experience authoring, review, etc. of procedures or training materials required



+ Experience with combination drug-device products and detailed knowledge of the associate Quality System Regulation requirements strongly preferred



+ Experience interacting with world-wide regulatory agencies and developing response actions



+ Experience leading project teams or staff required







**PHYSICAL/MENTAL REQUIREMENTS**



Normal activities include sitting, standing and walking in office and laboratory settings.







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



Anticipated travel is 5-15 % and could include domestic and foreign travel. Some off hour (night/weekend/holiday) support may be required to support staff.







**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.







This job is open only to Lawful Permanent Residents (as defined by 8 U.S.C. 1101(a)(20)), or Protected Individuals (as defined by 8 U.S.C. 1324b(a)(3), namely, U.S. Citizens, Refugees, and Asylees.







**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: 4 January, 2018**



**Eligible for Relocation Package**







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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