Senior Manager, Stability Administration & Rapid Action

ROLE SUMMARY

The Senior Manager for the Stability Administration and Rapid Action teams is responsible for providing strategic leadership for managing functions of stability operation, investigation of significant quality events, and quality improvement initiatives at the Rocky Mount Facility.

Key responsibilities include providing strategic direction to management of stability operation to meet defined quality standards and objectives; comply with global regulatory requirements and stability commitments; manage submission-ready stability protocols and reports; support stability needs for new product launches and/or filing updates. Facilitate collaboration with the broader Quality organization to optimize investigation processes, ensuring timely completion of investigation to allow timely closure of significant investigations and to identify effective CAPAs to resume compliant cGMP activities. The Senior Manager will also provide technical support to the Rapid Action Investigations team, participating in cross-functional teams to resolve technical challenges and to support quality functions to maintain compliance with the site cGMP and regulatory requirement, such as FAR, AQRT, eSQRT, etc.

The Senior Manager will ensure cost effective activities/programs are implemented in compliance with regulatory standards, company policies, practices, and processes.  Fosters teamwork and colleague development, as well as change management, within the department and the function, and plan, organize, and evaluate activities across these teams to ensure alignment with operational goals and long-term site initiatives.

Experience in management of stability operations and investigation of significant event is required, along with a working knowledge of relevant regulations. The Senior Manager is expected to frequently visit the manufacturing floor to ensure compliant cGMP activities at the site, gain an understanding of manufacturing processes, and drive improvements across the labs in support of site metrics and initiatives.

Additional responsibilities include implementing and managing quality improvement initiatives for the site, driving continuous process improvements, optimizing resources, and supporting the implementation of IMEX across the teams.

A deep understanding of ICH and regulatory guidance and investigational principles is required. The incumbent must be able to work cross-functionally to support commercial manufacturing activities and product stability monitoring activities.

The Senior Manager will advise Quality Leadership on stability administration, providing data analysis and trend insights to ensure compliant cGMP operations in stability operations and significant event investigations. Experience in presenting technical materials to regulatory auditors, such as the FDA, TGA, and MHRA, is also required.

ROLE RESPONSIBILITIES

• Serve as the technical and functional expert, providing leadership and direction for the site's stability administration.
• Lead and actively participate in lean initiatives/projects to drive continuous improvement across the laboratories.
• Conduct routine assessments of stability administration, significant event investigations, quality improvement initiatives and collaborate with management to identify opportunities for enhancement, developing strategies and action plans for improvement.
• Ensure the availability of comprehensive training and coaching resources for Stability Administration and Rapid Action Investigation teams to support site objectives.
• Influence best practices across the network by actively contributing to global discussion groups and collaborating with user council representatives to drive system improvements.
• Manage resources effectively to achieve organizational goals, including leading, developing, and engaging a diverse team of colleagues through performance reviews, development discussions, team building, and fostering a results-driven culture.
• Build and maintain relationships across multiple organizations to ensure consistent site practices that align with local, corporate, and regulatory requirements.
• Uphold site safety objectives by maintaining a safe working environment, including adherence to 5S principles and ergonomic standards.
• Promote a culture of lean operations by systematically reviewing and refining existing work practices to eliminate non-value-added activities.
• Establish and enforce standards, processes, and procedures to ensure compliance with regulatory requirements and Pfizer Quality Standards for stability operation and deviation investigation activities.
• Provide strategic direction to the Stability Administration and Rapid Action Investigation teams to align with long-term site goals, PQSs, BOH requirements, and evolving industry standards.
• Collaborate with key stakeholde