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Site Quality Operations Leader

Pfizer


Location:
Adelaide, GA 31730
Date:
02/08/2018
2018-02-082018-03-11
Pfizer
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Job Details

POSITION SUMMARY



The purpose of the Site Quality Operations Leader (SQOL) is to manage the local Quality Operations (QO) team, including Quality Control (QC), and to establish, maintain and improve an effective Quality Management System (QMS) in compliance with internal and external standards/requirements/dossiers within PGS Adelaide and over the entire life cycle of the product or material.







**POSITION RESPONSIBILITIES**



The responsibilities of the Jobholder are to:







+ Manage, develop and assign resources to quality operations team at PGS Adelaide.



+ Ensure that an effective system is in place to monitor effectiveness and compliance of the Quality Management Systems(QMS) throughout PGS Adelaide.



+ Ensure the development, implementation, maintenance and improvement of quality systems/processes QA and QC.



+ Establish effective operational mechanisms to oversee the performance of the QMS.



+ Ensure effective stability program management processes and ensure compliance to internal and external regulations.



+ Ensure Site Inspection Readiness for Pre approval Inspection(s) as well as internal and external cGMP Inspections



+ Ensure commitment/submission-related tasks are fulfilled in a timely and compliant manner.



+ Follow Notification to Management procedures to escalate any potential quality defect or cGMP non-compliance to the Operating Unit QO Leader.



+ Communicate to leadership on a frequent basis the key quality performance metrics used to demonstrate QSM effectiveness.



+ Establish processes to interface with key stakeholders, such as Regulatory Affairs (RA), Global Chemistry Manufacturing Controls (GCMC) and others to ensure efficient workflow.



+ Establish, maintain and improve an effective Supplier Quality Management system for the site.



+ Manage third-party inspections and to perform self appraisals and supplier audits.



+ Manage the site budget and headcount within the area of responsibility.



+ Represent the quality lifecycle management responsibility.



+ Keep current with Pfizer standards, guidances and regulations.











**ORGANIZATIONAL RELATIONSHIPS**



The Jobholder is the primary contact person for all functions at PGS Adelaide for interfaces with the global Biotech Quality Leadership team, GCMC, RA, product team leaders, COQA, Ministries of Health, affiliate organizations, contractor , quality organization, other Pfizer Global Supply (PGS) sites







**RESOURCES MANAGED**



**Financial Accountability**



The Jobholder manages the QO Budget at PGS Adelaide



**Supervision**



The Jobholder is responsible for the site QO team of ~40 colleagues plus any contract workers supporting QO. The Site Quality Leadership team reports to the SOQL.







**EDUCATION AND EXPERIENCE**



Education:







+ Scientific or pharmaceutical educational background (university, FH, HTL).







Professional experience:







+ >5 years of QA/QC experience within a pharmaceutical company.



+ Good knowledge of relevant pharmaceutical, biologic and medical device regulations, including ISO 9001, ISO 13485, international GXP Guidelines and cGMP 21 CFR 210/211/600/820.



+ Experience with implementation of cGMP compliant Quality Management Systems.



+ Experience in quality assurance and quality control.



+ Biotechnological and/or pharmaceutical understanding.







Special skills:







+ Strong leadership skills.



+ Process oriented, analytical and problem solving abilities.



+ Excellent organizational and interpersonal skills.



+ Proactivity.



+ Team-spirit.



+ Accuracy.



+ Consequence.



+ Integrity.



+ Excellent written and verbal communication skills.



+ English, spoken and written.



+ Proficiency in Microsoft Office (Word, Excel, and PowerPoint).











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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