Senior Manager, Quality Assurance Investigations in Devens, MA

Senior Manager, Quality Assurance Investigations

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. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.

Responsibilities

Manages and executes operating procedures for the site quality assurance program for the investigation and resolution of deviations, CAPA, and complaints. Provides direct supervision of personnel approving investigations and CAPA. Performs review and approval of site and department SOPs. Develop and manage the training curriculum of direct reports as it relates to investigations, CAPA, change controls, protocols and reports. Provide oversight of Investigations / CAPA management and tracking to ensure timely and compliant closure. Contributes to and supports the site team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products. Directly participates in internal audits or reviews as well as global health authority inspections. Hires, integrates and develops high quality talent, capable of delivering against the department goals and objectives. Establish and communicate performance objectives for Quality Assurance staff that are consistent with the company goals and objectives. Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment enhances unit performance and integration across site departments. Provides oversight to identify and implement changes that lead to realization of long-term department goals.

Knowledge, Skills, Abilities

Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is required. Strong background and demonstrated effectiveness in quality assurance operations. Knowledge of cell therapy, analytical testing or biotech bulk and finished product manufacturing is highly desirable. Knowledge of US and EU cGMP regulations and guidance. Knowledge and proven experience in FDA, EMA, or other regulatory authority. Demonstrated leadership, interpersonal, communication, and motivation skills. Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant 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. Must possess an independent mindset and tenacity. Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision. Work is self-directed. Confident in making decisions, able to anticipate Quality issues and proactively solve problems. Routinely recognizes Quality issues and solves problems. Is recognized Subject Matter Expert within the group. Able to prepare written communications and communicate problems to management with clarity and accuracy. Able to effectively multi-task. Demonstrated experience with electronic system and databases. Demonstrated proficiency in root cause analysis tools including but not limited to 5-WHY, Human error prevention, Ishikawa Diagram (Fishbone Analysis), Process Flow Diagram, etc.

Basic Requirements

A minimum of 8-12 years' experience in biopharmaceutical operations with prior management experience required. Equivalent education, experience or demonstrated competency will be considered. Experience in building and growing an organization into a high-performance team.

Compensation Overview : Devens - MA - US : $138,670 - $168,034 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https : / / careers.bms.com / life-at-bms / .