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Remediation Director

Pfizer


Location:
Southfield, MI 48075
Date:
12/29/2017
2017-12-292018-01-29
Pfizer
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Job Details

**ROLE SUMMARY**







The **Remediation Director** is focused on strengthening of site Quality systems through leading quality, manufacturing, engineering, with a focus on validation of pharmaceutical manufacturing facilities and systems. The director will be responsible for the standards, planning and execution of the master validation to remediate all aspects of the facility. Activities may include development, coordination and execution of testing, change requests, protocols and document revisions as required to meet regulatory and cGMP requirements.







+ Lead the development and execution of validation remediation activities for a respective area (i.e. Engineering, Validation, Operations, Quality, etc.)



+ Manage project activities through provision of oversight and guidance.



+ Provide oversight for execution of the remediation strategy.



+ Preview/provide feedback and technical/scientific support on any project deliverable, i.e. remediation strategy, plan reports, etc.



+ Monitor and communicate progress to ensure commitment actions are completed according to the defined plan.



+ Develop standards and procedures to align with corporate and industry standards.







**ROLE RESPONSIBILITIES**







+ Direct a team of professionals in the execution of remediation activities for respective area (Engineering, Operations, Quality or Validation)



+ Responsible for reporting progress on remediation activities to the Program Management Office for presentation to Regulatory Agencies and Pfizer senior management team.



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



+ Engage, influence, and coordinate all functions needed to execute/implement projects.



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



+ Recommend 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; prior Engineering, Operations, Quality or Validation assignments preferred.



+ Experience authoring, review, etc. of procedures and protocols



+ Experience leading project teams or staff required







**PHYSICAL/MENTAL REQUIREMENTS**







+ No unique physical requirements



+ Mental:



+ Remains organized & positive in ambiguous and fast-paced, rapidly changing situations



+ Ability to analyze data from detailed schedule and risk management tools



+ Interface effectively with multiple stakeholder groups







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







Extensive travel required. Non-standard work hour in support of global conference calls, 24/7 manufacturing, etc. required when needed, though not typical of weekly requirements.







**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 for Job:** 11 January, 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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