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Quality Manager Biotech

Pfizer


Location:
Castle Rock, CO 80104
Date:
01/26/2018
2018-01-262018-02-26
Pfizer
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Job Details

To partner with other QA and QC Functional Leadership to ensure that products are manufactured and tested to cGMP requirements underpinned by efficient and effective Quality processes supporting timely data reporting for a high volume multiproduct Biotechnology site.







**General Information:**



**Job Title:**



Quality Manager Biotech



**Department:**



Quality Operations (QA / QC)







**Position Reports to:**



Head of Quality Operations **Job Purpose:**



To partner with other Quality Assurance and Quality Control Functional Leadership to ensure that biotechnology products are manufactured and tested to cGMP requirements underpinned by efficient and effective Quality Assurance /Quality Control processes / systems supporting timely data reporting for a high volume multiproduct Biotechnology manufacturing and testing site.







**Job Responsibilities:**







+ Lead the site Board of Health and Internal Regulatory Inspection / Audit program ensuring compliance with corporate and site standards, overseeing and developing associated action plans, as necessary.



+ Support the Quality Operations (QO) compliance team together with the site regulatory inspection readiness program.



+ Lead the Quality Business Planning team to develop and monitor the capital and expense budgets for the Quality Operations department ensuring all teams operate within the formalized budgets.



+ Lead and enhance the site and Biotech OpU Stability Programme, Stability Review Board (SRB) and associated reporting, as well as any related product registration requirements.



+ Lead and drive the continuous enhancement and effectiveness of QA and QC quality systems and processes.



+ Oversee the Data Integrity (DI) programme for QC supporting the overall site Masterplan.



+ Drive the development of timely and efficient QO data reporting capabilities through laboratory information systems.



+ Champion and support the implementation of the site Zero Defects strategy and the implementation and review of appropriate CAPAs.







Be a key contributor to the respective Quality Operations forums including QO Business Reviews, Site Inspection Readiness, QO Tech & Reg, SQRT (Site Quality







+ Review Team) meetings.



+ Responsible, in conjunction with other QO Leadership, for the representation of the QO during FDA, HPRA and other BOH Regulatory PAI and Compliance Inspections.



+ Promote a high standard of Quality behaviours and ensure compliance with appropriate Quality Standards, Procedures, and Product Specifications within QO



+ Conduct routine cGMP compliance and RFT area walkthroughs of Manufacturing Operations.



+ Participate in the internal audit program and conduct supplier audits as required.



+ Foster an environment of continuous improvement through the use of available tools including, but not limited to, Lean, Six Sigma, Error reduction (PHP)



+ Participate in cross-functional and network teams as required.



+ Perform and assist with additional duties as may be directed by the Site Lead Quality Operations.



+ Network and liaise as appropriate with other Quality professionals inside and external to Pfizer, as necessary, to ensure ongoing maintenance of incumbent's knowledge of the definition of evolving Quality standards.







**Education/Experience** - To be successful in this role you will require:



- B.Sc. degree in biotechnology, biology, chemistry, or other related technical degree.



- 10 years working experience in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment; at least 3-5 years must have been in a leadership capacity.



- A Qualified Person status is preferred (QP status per European Union Pharmaceutical Regulation) Previous experience in Quality Assurance (QA) Compliance / QA Operations / Quality Control / QC Stability program management for Pharmaceutical or Biotechnology products is required.



- Experience of Quality systems and processes within the Pharmaceutical / Biotechnology industry is desirable.



- Working knowledge of business systems such as Trackwise, Labware LIMS & SAP is desirable.



- Practical pragmatic mindset capable of balancing quality, compliance and business imperatives.



- Proven capability in managing ambiguity, sound decision making and thinking strategically.



- Ability to work independently as well as a member of a team in a dynamic, fast-paced environment







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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