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Manager, Aseptic Compliance (R3) Technical Sterility Services

Pfizer


Location:
Rocky Mount, NC
Date:
03/27/2018
2018-03-272018-04-27
Pfizer
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Job Details

**ROLE SUMMARY**



The primary function of this position is to support the Rocky Mount sterile manufacturing in the newly constructed R3 facility. The manager will be responsible to working with the R3 colleagues and other stakeholders to develop necessary strategies, work plans and schedules for the following:



1. Contamination Control for the facility



2. Training for colleagues who will be designate to the facility



3. Media fill strategy and execution



4. Smoke studies strategy and execution



5. Aseptic manipulation/process







The manager will be responsible for working with the R3 colleagues to develop proper aseptic interactions/techniques to ensure the product/equipment is compromised during qualification and subsequent manufacturing. The manager will be responsible to ensure that the new processes which are developed are aligned with Pfizer Quality Standard (PQS), regulators and industry best practices. The incumbent will need to communicate/partner with the global compliance experts/advisors and other Pfizer locations to ensure alignment to develop best in class operation.







This candidate must be able to work cross functionally and globally with corporate partners and other site compliance leaders while working alongside Rocky Mount' colleagues in BQ, Operations, Maintenance, Validation and MQ to deliver key milestones for projects/improvements.







**ROLE RESPONSIBILITIES**







+ Perform necessary assessments of sterile operations, and work with the R3 team to ensure proper process development, implementation and compliance with PQSs, regulations and industry standards.



+ Work with the R3 team and Technical Sterility Services (TSS) to develop necessary training for colleagues working in the area.



+ Work with department leaders to ensure training materials are adequate for the job functions.



+ Maintaining working knowledge of cGMPs and emerging regulatory and compliance concerns as related to sterile manufacturing.



+ Liaise with corporate compliance team, TSS and other site departments to ensure alignment.







**QUALIFICATIONS**







+ Bachelor's Degree required, Master's Degree preferred in a technical field, such as Engineering/Microbiology



+ 10+ year experience in an aseptic environment or supporting aseptic manufacturing preferred.



+ 2+ years supervisor experience in the aseptic manufacturing environment preferred



+ Requires strong oral, written, communication, presentation and interpersonal skills.



+ The position is self-directed and requires an appropriate level of education, experience and confidence to make and act upon decisions that impact the site and larger Pfizer network.



+ Requires thorough/working knowledge of GMP's, PICS and ISO and expertise in sterile processing.



+ Must have demonstrated ability to handle multiple projects in a dynamic environment.







**PHYSICAL/MENTAL REQUIREMENTS:**







+ Must be able to function under a stressful situation while being able to remain focused at the necessary requirements.



+ Must be able to appropriately identify and escalate issues on a timely basis.







**WORK SCHEDULE:**







+ Must be able to work on weekend, off shifts and holiday as business demands.



+ Must be able to travel overseas and to other sites.







**ORGANIZATIONAL RELATIONSHIPS:**







+ The Manager, Aseptic Compliance (R3) must interact with Pfizer corporate personnel (MAS team), cross-site colleagues, and industry experts to develop necessary processes for the sterile manufacturing program in the newly constructed facility, R3.



+ Encompasses responsibility for the implementation of key aseptic/sterile principles, drive accountability and support GMP requirements in manufacturing. This position requires the incumbent to assess situations in relation to regulatory requirements, site and corporation requirements.



+ Independent action and sound decision-making are essential for success in the position as decisions made can impact short and long-term site objectives. Must be able to simplify complex matters and be able to present with clarity, confidence and thoughtfulness.







**SUPERVISION:**







+ Indicate the typical number of Colleagues managed; include direct & indirect reports and matrix responsibility. Note if direct reports are people managers or individual contributors. Indicate additional resources (i.e. contingent workers) managed, as applicable.



+ Will be responsible for develop the contamination control staffing model to support manufacturing in the new facility. As operations in R3 ramps up additional TSS headcount will be added to support the facility.







**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:**







+ 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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