Manager, Quality Engineering, Change Control/Document Review

Bristol Myers Squibb • Madison, WI

11h

About The Position

The Manager, Quality Engineering, Change Control/Document Review at the Summit Cell Therapy Manufacturing facility supports the business process owner for the Change Control module and its governing local procedures and supporting processes. This highly visible, site-responsible role has cross-functional influence and impacts departmental performance and broad quality change control management. The incumbent serves as the site subject matter expert for the Change Control process.

The role manages and supports change control for GMP activities, reviews and approves change controls and related documents for appropriateness and compliance with regulatory requirements and internal procedures, and supports process improvement initiatives. The manager also provides subject matter expert support during internal and health authority inspections and communicates with cross-functional stakeholders on change control matters.

The position requires strong written and verbal communication, analytical and decision-making skills, and the ability to recognize and resolve quality issues, develop procedures, interpret complex results, and recommend resolutions. The incumbent works independently on routine tasks, seeks management guidance on complex matters, and provides guidance to others in change control technical writing.

Requirements

• Experience with cGMP manufacturing, Quality, and Compliance.
• Strong authorship skills and ability to critically evaluate change controls and generate technical conclusions consistent with Quality risk management principles.
• Ability to routinely recognize quality issues, interpret problems, and propose solutions for complex issues.
• Understanding of continuous improvement and ability to improve quality-system compliance and efficiency.
• Ability to prepare and convey data analysis clearly and accurately to management and others.
• Self-directed, able to complete routine tasks independently, and confident making decisions within the subject matter area; consults management on decisions outside established processes.
• Requires moderate direction to complete more complex tasks.
• Comfort providing input and guidance on change control technical writing.
• Ability to support internal and health authority facility inspections.
• Understanding of Change Controls and why they are required.
• Bachelor of Science degree required; a college or university degree is required. An equivalent combination of education and experience may be substituted.
• Minimum of eight years of experience in the pharmaceutical or a related industry.

Responsibilities

• Manage the change control quality process for GMP activities and coordinate with cross-functional areas to ensure timely completion.
• Review and approve change controls and associated documents for appropriateness and compliance with regulatory requirements and internal procedures.
• Drive or support process improvement initiatives.
• Provide subject matter expert support during internal and health authority inspections of the facility.
• Communicate effectively with cross-functional stakeholders about the change control process.
• Recognize and resolve quality issues, and inform management of proposed solutions.
• Develop procedures and interpret complex results and situations, articulating recommendations for resolution.
• Prepare and communicate data analysis, written communications, and problems to management and others with clarity and accuracy.
• Provide input and guidance to others in the department and across the organization on change control technical writing.
• Propose solutions to issues and work with management to resolve them; recognize conflicts and notify management with recommendations.
• Write and review reports with clarity and brevity.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings.
• Flexible Time Off for eligible U.S.-based exempt employees, subject to manager approval.
• Paid vacation for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico.
• 11 paid company holidays annually; eligible employees in specified groups also receive three optional holidays.
• Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer-hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year's Day.
• Potential eligibility for discretionary incentive cash and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager