Manager, Quality Engineering, Change Control/Document Review

Position Summary

The Manager, Quality Engineering, Change Control/Document Review at the Summit Cell Therapy Manufacturing facility is responsible for supporting the business process owner for Change Control module and the associated governing local procedures and supporting processes. This is a highly visible role with site responsibility and cross-functional influence that has impact on departmental performance and broad quality change control management. The incumbent will serve as the subject matter expert for the Change Control process across the site.

Duties/Responsibilities

• Manages the change control quality process for all GMP activities and works with responsible cross functional areas to ensure timely completion.
• Review and approve change controls and associated documents for appropriateness and to ensure records are in compliance with regulatory requirements and internal procedures.
• Drive or support process improvement initiatives.
• SME support during internal and health authority inspections of facility.
• Communicates effectively with cross functional stakeholders on matters related to change control process.
• Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Has advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge.
• Routinely recognizes and resolves Quality issues; informs management of proposed solutions. Seeks management guidance on complex issues; develops procedures.
• Ability to fully interpret complex results and situations and articulate recommendations for resolution.

Qualifications

• Must have experience with cGMP manufacturing, Quality, and Compliance.
• Must have strong authorship and be able to critically evaluate change controls and generate technical conclusions consistent with Quality risk management principles.
• Must be able to routinely recognize quality issues and interpret problems, as well as proposed solutions for complex issues.
• Must understand continuous improvement and be able to improve the compliance and efficiency of the quality system.
• Must be able to effectively prepare and convey data analysis to management and others within the group with clarity and accuracy.
• Must be self-directed, complete routine tasks independently and be confident in making decisions in respective subject matter area, consulting with management for decisions outside of established processes.
• Requires moderate direction to complete more complex tasks.
• Comfortable providing input/guidance to others within the department and across the organization in change control technical writing.
• Propose solutions for issues and work with management to resolve.
• Able to recognize conflict and notify management with proposed recommendations for resolution.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Able to support internal and health authority inspections of facility.
• Understanding of Change Controls and why they are required.
• Able to write and review reports with clarity and brevity.
• Bachelor of Science degree required.
• Minimum of eight years of experience in the pharmaceutical or related industry.
• College or university degree required. An equivalent combination of education and experience may be substituted.