Job Details
Quality
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.
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. Read more: careers.bms.com/working-with-us.
Position Summary
This role will be responsible to provide senior leadership to the QC Operations organization and oversee QC Analytical, QC Microbiology and QC Systems activities to ensure efficient and high-quality release of product to cell therapy patients. This individual will be a key member of the team responsible for the design, implementation, and continuous improvement of all the systems and processes in support of the Devens CTF QC Laboratories, along with meeting on time completion of testing to support lot disposition turnaround times.
The Director of QC Operations will be a key member of the CTF Quality Leadership Team and a champion for quality principles and compliance within the Devens Cell Therapy organization.
This role is stationed in Devens, MA and reports to the Executive Director of Quality for the Devens Cell Therapy Facility.
Key Responsibilities
Demonstrate leadership and experience for QC Laboratory practices for the QC Analytical, QC Microbiology and QC Systems functions for Cell Therapy products manufactured at the Devens Cell Therapy Facility.
Direct the daily operation of a QC organization to support the release of cell therapy products.
Define departmental roles and accountabilities. Hire, integrate and develop high quality talent capable of delivering against the site’s goals and objectives.
Establish and communicate performance objectives for QC Operations staff that are consistent with the business unit and Quality goals. Define and enforce performance measures, provide developmental feedback and coaching, and create a collaborative environment that attracts, develops, and retains the best talent.
Direct the training and scheduling of QC Operations staff to assure testing activities occur in an efficient and cGMP compliant manner.
Direct programs or procedures which assure the proper qualification, calibration, operation and maintenance of laboratory equipment, the timely data analysis and reporting of trends, and the completion of written investigations in response to unusual or unexpected results or deviations.
Direct QC department programs and projects related towards the goal of continuous improvement.
Participate in the site team, which prepares for, hosts, and responds to regulatory inspections, reviews, and approvals of the facility and products.
Accountable for on time, quality laboratory investigations and associated CAPAs within the electronic investigation management system, as needed.
Support completion of Annual Product Quality Review and periodic investigation trending reports.
Verify compliance with applicable BMS Policies and Procedures and ensure consistency with other site procedures and/or specifications.
Responsible for managing the QC Operations budget.
Qualifications & Experience
A minimum of 10 years in biopharmaceutical quality with a minimum of 6 years of increasing management responsibility.
Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is required.
Experience leading and managing a large, multi-leveled organization is essential.
In depth knowledge of common QC procedures, techniques, and laboratory equipment/instrumentation, and the application and interpretation of GMP concepts and compendia requirements (e.g., USP, CFR).
Proficiency in analytical assay methodologies and microbiological assays.
Demonstrated leadership, interpersonal, communication, and motivation skills.
Knowledge of cell therapy or biologics manufacturing is highly desirable.
Extensive knowledge of US and EU cGMP regulations and guidance.
Extensive and proven experience in FDA (or other regulatory authority) inspection preparation and management is essential.
Knowledge of applicable business systems (e.g., SAP, LIMS, LES, Maximo, and Infinity) preferred.
Demonstrated ability in successfully leading a large multi-level organization.
#BMSCart, #LI-Hybrid, #Veteran
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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