Associate Director, Quality Engineering
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS’s continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.
Bristol Myers Squibb is seeking an Associate Director of Quality Engineering at the Cell Therapy Facility (CTF) in Devens, MA. This individual will be 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), and process validation. This role will also be responsible for the administration and maintenance of the Devens CTDO change control system assuring consistency with established standards for local and global change control systems as well as leadership and oversight of computer system change management programs.
This role is stationed in Devens, MA and reports to the Director of Quality Assurance (QA) for the Devens Cell Therapy Facility.
Designs, develops and directs a successful strategy for QA oversight of commissioning, qualification, and validation activities required for the startup of a cell therapy manufacturing facility.
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.
Ensures that all regulatory and cGMPs compliance items related to validation are satisfied.
Directs the administration and maintenance of the site change control system assuring 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.
Demonstrates appropriate examples for compliance behaviors and attitudes, thereby shaping the culture.
Establishes and communicates performance objectives for Quality Engineering staff that are consistent with the businesses 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 receptivity, collaboration, clarity of purpose and goals, and high commitment to achieve business goals.
Meets and exceeds all safety expectations and adhere to all BMS behaviors.
Participates with BMS staff in responding to inquiries from audits and inspections from world health authorities.
Ensures that all Quality Engineering personnel have adequate training, education and experience to perform their GMP related job function effectively.
Provides Quality oversight toward Validation Master Plan (VMP) adherence.
Provides Quality oversight on Technology Transfer activities.
Verifies compliance with applicable BMS Policies, Guidelines and Directives and ensures consistency with other site procedures and/or specifications.
Qualifications and Education Requirements
Knowledge of Science generally attained through studies resulting in a Master’s Degree in a scientific or engineering discipline or equivalent education and experience.
A minimum of 8 years experience in an environment governed by cGMPs, including at least 3 years of experience in biologics or cell therapy operations and at least 3 years of experience in validation.
Experience in building and growing an organization into a high performing team.
In depth knowledge of cGMP and regulatory requirements for validation of equipment, computerized systems, and processes.
Proficiency in the use of computers and software applications including electronic change control systems
Demonstrated leadership, interpersonal, communication, and motivation skills.
Knowledge of applicable business systems including: SAP, LIMS, Maximo and Veeva Vault are desirable
Knowledge of manufacturing executions systems such as Syncade and distributive control systems such as DeltaV is desirable
Effective written and verbal communication skills
If you want to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients’ lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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