Senior Quality Engineering - Change Control Lead

Bristol-Myers Squibb Co; Madison (NJ); On-site; USD 117,000 - 141,000; Full time

Benefits offered by this job

Wellbeing support

Retirement plan

Insurance (medical, dental, vision)

Job summary

Bristol Myers Squibb Co is seeking a Manager, Quality Engineering, Change Control/Document Review for the Summit Cell Therapy Manufacturing facility. You will oversee Change Control, review documents for regulatory compliance, and drive process improvements with cross-functional teams to ensure timely completion.

The role requires cGMP experience, extensive change control writing, and strong data analysis. You will support inspections and contribute to quality system improvements in a fast-paced

Qualifications

• Must have experience with cGMP manufacturing, Quality, and Compliance.
• Strong authorship and ability to evaluate change controls with quality risk 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.

Responsibilities

• Manages the change control quality process for all GMP activities and works with responsible cross functional areas 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.

Skills

Quality mindset

Authorship

Data analysis

Communication

Problem solving

Decision making

Cross-functional collaboration

Change control writing

Self-directed

Education

Bachelor degree

College degree

Job description

Bristol Myers Squibb Co is seeking a Manager, Quality Engineering, Change Control/Document Review for the Summit Cell Therapy Manufacturing facility. You will oversee Change Control, review documents for regulatory compliance, and drive process improvements with cross-functional teams to ensure timely completion.

The role requires cGMP experience, extensive change control writing, and strong data analysis. You will support inspections and contribute to quality system improvements in a fast-paced