Hybrid Contractor Quality & Regulatory Lead

at Pfizer

• Job title: Contractor Quality & Regulatory Lead
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Walton Oaks, United Kingdom

About the role

• Quality Assurance Manager at Pfizer managing external contractors and ensuring regulatory compliance in manufacturing processes. Leading quality assurance initiatives and fostering relationships with key stakeholders.

Responsibilities

• The ESOQ Manager is accountable for providing quality assurance management of key contractors for Pfizer.
• Assure that the products supplied to our patients are manufactured & tested in accordance with c-GMPs, the registration file and any additional country specific requirements.
• Operate independently with minimal supervision, interacting with high levels of management both at contract manufacturers and within Pfizer.
• Focus on developing relationships, independently negotiating, developing and communicating Pfizer quality requirements with contract manufacturers.
• Significant interactions with many internal business and manufacturing organizations (e.g. External Supply, Regulatory, Technical Support, Quality, PGS sites and R&D) and lead virtually-based cross functional teams.
• Initiate, review and approve regulatory changes through Pfizer enterprise system (i.e PDM) for changes initiated by or impacting ESOQ managed contractors.
• Provide support for the closure of deficiency letters, CMC Commitments, Regulatory requests for Renewals, New Product registrations and Post approval variations.
• Main point of contact for Global Chemistry Manufacturing & Controls (GCMC) dpt or Local Regulatory Affairs in Pfizer Country Offices (Single market prods) for the regulatory activities involving the ESOQ contractors.
• Participate in Virtual Site Operating Teams (VSOT) or similar meeting for ESOQ managed contractors and if needed, participate in Site Quality visits at the contractors.
• Support and Perform Lot Disposition for Biotech semi finished and finished products (if applicable).

Requirements

• Minimally BA/BS Science, Engineering, or related technical discipline with strong experience in a GXP setting and/or Regulatory Affairs role.
• Some experience in Product Quality Assurance experience in a GMP environment.
• Aseptic manufacturing experience would be an asset.
• Advanced computer skills, MS Office and enterprise systems such as SAP, QTS, PDM, Documentum platforms.
• Command of English language required and multi-lingual is a benefit.
• 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 and priorities.
• Demonstrated ability to prioritize work, to act and work independently and to report items as required to Team leader.
• Demonstrated 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.
• Able to deliver work independently.

Benefits

• Health insurance
• Retirement plans
• Paid time off
• Flexible work arrangements
• Professional development opportunities