The Senior 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.
• Provide Quality Leadership within the cross functional virtual site operating teams (VSOT).
• Lead the development, implementation and support of QA/QC systems for Global Biopharmaceutical products and medical devices operated by the Contract partner.
• Support new product launches and assists with 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 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 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 with at least 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 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
• Detailed knowledge of the manufacture and packaging (primary and secondary) of Aseptic / Sterile pharmaceutical products would be an advantage.
• Possess an in-depth knowledge of quality system regulations, including a demonstrated ability to evaluate and apply global GMP’s to build effective Manufacturing/QA/QC systems.
• Being an excellent team worker with demonstrated communication and influencing skills, successful candidate shall have the ability to interact effectively across functions and at all levels with contract partners, including demonstrating a cultural sensitivity to ensure effective relationships are built and sustained.