Manager, Quality Engineering, Change Control/Document Review

Bristol Myers Squibb • Madison, NJ

2d • $116,660 - $141,368

About The Position

The Manager, Quality Engineering, Change Control/Document Review at Bristol Myers Squibb’s 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 role has site responsibility and cross-functional influence, with an impact on departmental performance and broad quality change control management. The incumbent serves as the site subject matter expert for the Change Control process.

The position manages the change control quality process for GMP activities, reviews and approves change controls and associated documents, supports process improvements, and provides subject matter expertise during internal and health authority inspections. The manager works across functions to support timely completion, compliance with regulatory requirements and internal procedures, and effective resolution of Quality issues.

The role requires strong technical writing, analytical, communication, decision-making, relationship-building, problem-solving, planning, and coaching abilities. The manager routinely recognizes and resolves Quality issues, develops procedures, interprets complex situations, and recommends solutions, seeking management guidance on complex matters. The role requires a Bachelor of Science degree and at least eight years of experience in the pharmaceutical or a related industry. An equivalent combination of education and experience may be substituted.

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 the compliance and efficiency of the quality system.
• Ability to prepare and convey data analysis to management and colleagues clearly and accurately.
• Self-directed, able to complete routine tasks independently, and confident making decisions within the respective subject matter area; consults management on decisions outside established processes.
• Requires moderate direction to complete more complex tasks.
• Comfortable providing input and guidance to others in the department and across the organization in change control technical writing.
• Ability to support internal and health authority inspections of the facility.
• Understanding of Change Controls and why they are required.
• Ability to write and review reports with clarity and brevity.
• Bachelor of Science degree required; college or university degree required. An equivalent combination of education and experience may be substituted.
• Minimum of eight years of experience in the pharmaceutical or related industry.

Responsibilities

• Manage the change control quality process for all GMP activities and work with responsible 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 on change control process matters.
• Recognize and resolve Quality issues, inform management of proposed solutions, and seek management guidance on complex issues.
• Develop procedures and interpret complex results and situations, articulating recommendations for resolution.
• Prepare written communications and convey problems to management with clarity and accuracy.
• Use advanced computer skills to increase departmental productivity and broaden technical and scientific knowledge.
• Support and guide others in change control technical writing.
• Analyze and convey data to management and others in the group.
• Propose solutions to issues and work with management to resolve them.
• Recognize conflicts and notify management with proposed recommendations for resolution.
• 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 without a set accrual limit for eligible U.S.-based exempt employees, subject to manager approval.
• Paid company holidays: 11 annually for eligible U.S.-based exempt employees; 11 paid company holidays and 3 optional holidays for specified other employee groups.
• For specified employee groups, 160 hours of paid vacation annually for new hires, subject to manager approval.
• 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 additional discretionary incentive cash and stock opportunities.

What This Job Offers

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