Pfizer Senior Manager in Tuas, Singapore
The Global Quality Operations Mission is "to be a proactive partner, driving a science and risk-based compliant quality culture that is flexible, innovative, and customer oriented, maximizing the contribution of Quality Operations to Our Path Forward initiatives."
Upjohn External Supply Quality is committed to supporting Upjohn Global Supply (UGS) as an innovative and competitive advantage for Upjohn by assuring the quality of products manufactured and packaged by other companies (Contractors) for Upjohn.
Upjohn External Supply Quality is responsible for the Quality management of approximately 80 contract manufacturers, packagers, and supply partners globally.
The Contractor Quality Lead Sr. Manager is accountable for providing quality assurance management of key contractors for Upjohn 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 Upjohn and Pfizer. (S)he will operate as spokesperson for External Supply Quality and will spend a significant period of time developing relationships, independently negotiating, developing and communicating Pfizer and Upjohn quality requirements with contract manufacturers.
The Contract Quality Lead Sr. Manager will have significant interactions with many internal business and manufacturing organizations (e.g. External Supply, Regulatory, Technical Support, Quality, Internal sites and R&D) and will lead and participate in virtually based cross functional teams. (S)he will report to the Director/Team Leader Upjohn External Supply Quality. Key responsibilities include:
Provide Quality Leadership within the cross functional virtual site operating teams (VSOT).
Lead the development, implementation and support of QA/QC systems for products processed and produced by CMOs
Support new product launches and technology transfers.
Partner with colleagues to develop and negotiate quality agreements.
Drive the development, implementation and continuous improvement of Quality Systems to support regulatory requirements.
Proactively support regulatory inspections at CMO's and ensure appropriate Pfizer review/approval of responses to Regulatory Agencies including tracking of CAPA's within QTS.
Provide Quality Leadership for significant deviations at CMO sites that may impact compliance status or require regulatory notifications.
Provide Quality Leadership and author support documentation for individual market release supporting documents to meet local regulatory requirements.
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 CMO's.
Accountable for the on time disposition of commercial products in line with agreed schedule.
Provide Quality leadership for customer complaint investigations and manage the relationship with the Pfizer PQC group and associated Pfizer sites.
Minimally BA/BS Science, Engineering, or related technical discipline
Minimally 10 years in a GXP setting
At least 5 years of Product Quality Assurance experience in a GMP environment
Experience with external suppliers/contractors 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
Shows strong negotiation skills
Is diplomatic in communication with internal and external customers
Demonstrated ability to manage multiple projects and complex contractors
Demonstrated ability to prioritize work, to act and work independently and to report items as required to Team leader.
Operates with minimal supervision
Has excellent organization skills
Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor
Demonstrated personal leadership to manage cross functional projects
Demonstrated ability to resolve conflicts
Takes initiatives and is proactive, persistent
Has a strong broad GMP and technical know-how to handle emerging issues
Flexi Work - Tuas (Singapore)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.