Sign In
 [New User? Sign Up]
Mobile Version

Manager

Pfizer


Location:
New York, NY 10011
Date:
01/04/2018
2018-01-042018-02-04
Pfizer
Apply on the Company Site
  •  
  • Save Ad
  • Email Friend
  • Print
  • Research Salary

Job Details

A career at Pfizer offers opportunity, ownership and impact.







All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.







IN LINE WITH GOOD DEVELOPMENT PLANNING , IT IS RECOMMENDED THAT COLLEAGUES DISCUSS THEIR SUITABILITY AND/OR READINESS FOR A NEW POSITION AND THEIR DIRECT MANAGER PRIOR TO APPLICATION. COLLEAGUES ARE REQUIRED TO INFORM THEIR MANAGER IF INVITED TO INTERVIEW FOR THE POSITION.







POSITION SUMMARY



Summarize the primary purpose &; key accountabilities of the position, 1eeincluding scope of responsibility in 5-7 concise sentences (i.e. Global vs. Country/Region).







Contract Operations Quality Assurance (COQA) is responsible for the Quality management of approximately 300 contract manufacturers, packagers, and supply partners globally. The Manager has responsibility for the effective Quality Assurance Management oversight of Pfizer partners and suppliers who manufacture or package Pharmaceutical products and/or devices on behalf of PGS. This role is globally focused with partners and suppliers in multiple geographic locations.







The COQA Manager is accountable for providing quality assurance management of key contractors / suppliers for Pfizer and for assuring that the products supplied to our patients are manufactured, tested in accordance with c-GMPs, the registration file and any additional country specific requirements.







This is highly independent position operating with minimal supervision, interacting with high levels of management both at contract manufacturers / suppliers and within Pfizer.







Flexibility with respect to travel is required (approx. 30%).







POSITION RESPONSIBILITIES



In order of importance, list the primary responsibilities critical to the performance of the position. Indicate the technical skills required and/or preferred, where applicable. It is recommended not to list actual tasks but focus on essential responsibilities that highlight accountability and level of judgment required.



Provide effective Quality Leadership for our vendor managed products including supporting the cross functional virtual site operating teams (VSOT) where they exist.



Successfully lead the implementation and support of Quality Assurance /Quality Control systems for Global Pharmaceutical products, API's / RSM's and medical devices operated by the Contract partner.



Develop and negotiate quality agreements.



Develop and negotiate Technical agreements with receiving sites.



Drive the development, implementation and continuous improvement of Quality



Systems to support regulatory requirements.



Proactively support regulatory inspections at vendors and ensure appropriate Pfizer







review/approval of responses to Regulatory Agencies including tracking of Corrective and Preventative actions (CAPA).



Provide Quality Leadership (including leader standard work) for notification to



management and significant deviations at contractor/partner sites that may impact



compliance status or require regulatory notifications.



Ensure implementation of effective CAPA and quality system improvements based



upon determined remediation activities.



Prepare AQRT summaries and participate in relevant meetings.



Lead quality risk management activities and manage mitigation plans within



partners and suppliers.



Accountable for the on time disposition of commercial products in line with agreed



schedule.



Provide Quality leadership for customer complaint or deviation investigations and track CAPAs accordingly.







ORGANIZATIONAL RELATIONSHIPS



Provide the primary groups or key positions that this position will have interaction with as a regular part of the position responsibilities. Include any external interactions as appropriate.







Reporting to COQA Director, Team leader.







COQA Manager will operate as spokesperson for COQA and will spend a significant period of time developing relationships, independently negotiating, developing and communicating Pfizer quality requirements with contract manufacturers / suppliers. The COQA Manager will have significant interactions with many internal business and manufacturing organizations (e.g., ES, GCMC, GTS, QO Center, PGS sites and PGRD) and will lead virtually based cross functional teams. The Manager COQA is accountable for providing quality assurance management of key contractors for Pfizer and for assuring that the products supplied to our patients are manufactured, tested in accordance with c-GMPs, the registration file and any additional country specific requirements.



This is highly independent position operating with minimal supervision, interacting with high levels of management both at contract manufacturers and within Pfizer. Will operate as spokesperson for COQA and will spend a significant period of time developing relationships, independently negotiating, developing and communicating Pfizer quality requirements with contract manufacturers. The COQA Manager will have significant interactions with many internal business and manufacturing organizations (e.g., ES, GCMC, GTS, QO Center, PGS sites and PGRD) and will lead virtually based cross functional teams.







+ Minimally BA/BS Science, Engineering, or related technical discipline with at least 8 years in a GXP setting



+ At least 4 years of Product Quality Assurance experience in a GMP environment



+ Experience with external suppliers/contractors is preferred



+ Deep understanding of sterile operation is preferred



+ Advanced computer skills, MS Office and enterprise systems such as SAP, QTS, Documentum platforms



+ Command of English language required and multi-lingual is beneficial.



+ Strong verbal and written communication including presentation skills



+ Up to 30 % travel required.



+ Shows strong negotiation skills and is diplomatic in communication with internal and external customers



+ Demonstrated ability to manage multiple projects



+ Demonstrated ability to prioritize work, to act and work independently and to report items as required to Team leader



+ Has excellent organization skills



+ Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor



+ Developing personal leadership to manage cross functional projects



+ Developing ability to resolve conflicts



+ Takes initiatives and is proactive, persistent



+ Has a broad GMP and technical know-how to handle emerging issues



+ Work location: Dalian, Suzhou, Wuxi or Shanghai







C:Plant Clock Standard - (China)



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Apply on the Company Site
Powered ByLogo

Featured Jobs[ View All ]

Featured Employers [ View All ]