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Associate Director, Quality Engineering, Cell
3 months ago
**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
**Position Summary**
The Associate Director, Quality Engineering is responsible for leading the Quality Engineering function. This team provides quality oversight of qualification and validation activities for start-up and ongoing operations of the Devens Cell Therapy Facility, including commissioning, qualification, and validation (CQV), computer systems validation (CSV), process validation, and change control.
**Key Responsibilities**
- Directs the QA oversight of commissioning, qualification, and validation activities required for cell therapy manufacturing facility, technology transfer, and product launches
- Leads team responsible for QA review and approval and decision making in the areas of process validation, computer system validation, facility, equipment, and utility qualification, and laboratory instrument qualification from both technical and compliance perspectives
- Performs technical quality review for complex system or process related studies and investigations
- Ensures that all regulatory and cGMPs compliance items related to validation are satisfied
- Directs the oversight of change control and IT change management, assuring efficiency and consistency with established standards for local and global change control systems
- Directs the quality oversight required for calibration and maintenance activities and ensures there are effective systems for the maintenance of laboratory equipment, facility and utilities
- Establishes and communicates performance objectives for Quality Engineering staff that are consistent with the business's unit and CTDO quality goals and objectives. Defines and enforces performance measures that attract, develop and retain the best talent
- Establishes a productive team-based environment, which promotes collaboration, clarity of purpose and goals, and high commitment to achieve business goals
- Demonstrates appropriate examples for compliance, safety and BMS values behaviors and attitudes, thereby shaping the culture
- Provides Quality oversight toward Validation Master Plan (VMP) adherence
- Influence and support continuous improvement of processes throughout the site
- Support resource planning for budgeting cycles
- Champion a culture of teamwork, communication, and continuous improvement
- Collaborate with cross-functional peers to proactively address risks/ critical issues and drive mitigations and escalate to senior management as needed
**Qualifications & Experience**
- Bachelor's degree or advanced degree in STEM field preferred. Equivalent combination of education and work experience may be considered.
- 9+ years of relevant experience (i.e., in a regulated GMP environment), preferably with 5+ years of increasing people management responsibilities and at least 4+ years of validation experience.
- Demonstrated proficiency with quality management systems.
- Demonstrated experience in resource planning/modeling and prioritization in a face-paced environment
- Advanced ability to interpret data & results, understand complex problems with multiple variables and critically assess and provide feedback on proposed solution and required documentation.
- Advanced ability to critically review investigation reports, interpret results, and assess and challenge technical conclusions consistent with Quality risk management principles
- Excellent verbal and technical writing skills with advanced ability to prepare written communications and present complex technical data to management with clarity and accuracy
- Ability to work in a fast-paced team environment and lead team and cross-functional peers through changing priorities.
- Ability to think strategically and effectively prioritize and allocate resources
- Advanced ability to influence cross-functional groups and teams to promote accountability and shape quality culture
- Ability to motivate and foster a positive cross-functional team environment
- Confident in making decisions, able to anticipate Quality issues and proactively solve critical and/or complex problems
- Curious, with the ability to think critically to create innovative solutions
BMSCART, #LI-Hybrid, #Veteran
**Uniquely Interesting Work, Life-changing Careers**
**On-site Protocol**
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, fie
