Search
Director, Quality Control

Director, Quality Control

locationUnited States
PublishedPublished: 5/15/2024
Full Time
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 .

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.

The Director, Quality Control provides leadership of the QC Analytical teams across multi shifts. The role oversees cGMP testing and supports technology and method transfers. The Director, QC is a key member of the Quality Control Leadership Team responsible for the design, implementation, and continuous improvement of all processes/systems in support of the Quality Control testing program at the Bothell Cell Therapy manufacturing site. In addition, the position will be responsible for executing quality policies, procedures and systems necessary to ensure adherence to QC testing operations in accordance with applicable Health Authority regulations.

Responsibilities:
  • Provide oversight of Quality Control (QC) analytical testing and oversees the day-to-day activities related to in-process, final release, and stability testing of drug product, and/or raw material testing.
  • Develops and manages a daily work plan for QC business needs.
  • Hire, mentor and develop exceptional QC personnel.
  • Coaches and develops team, by providing an environment that encourages ongoing personal and professional development. Manages and ensures the setting of goals, training and development opportunities, providing regularly scheduled feedback throughout the year.
  • Ability to effectively represent the company during interactions with FDA and other regulatory officials, demonstrating credible and substantial QC laboratory expertise.
  • Identifies and mitigates risks in QC laboratories, processes, and/or systems that could negatively impact the safety, identity, strength purity or quality of the product.
  • Assists in the design, implementation and continuous improvement of Quality Control systems and processes that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
  • Provides leadership support during troubleshooting of assay performance, equipment, systems, and/or processes as it relates to ensuring the quality and compliance of the product.
  • Directs QC laboratory operations to ensure that product and raw material testing is performed in compliance with regulatory agencies, cGMPs, and other company policies and procedures.
  • Ensures deviations, CAPA, change controls, process transfers, and other business drivers are supported in a compliant manner.
  • Analyze trends and generate metrics using statistical analysis.
Knowledge & Skills:
  • Ability to understand the site and appropriately network with stakeholders.
  • Strong working knowledge of cGMP regulations and Regulatory Agency requirements applicable to biologics and cell therapy manufacturing.
  • Demonstrated experience building and leading exceptional teams.
  • Ability to apply Lean, Six Sigma and Risk Management concepts and tools is preferred.
  • Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects.
  • Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others.
  • Demonstrated success working in a high-performing, business results-driven environment.
Basic Requirements:
  • BS in a scientific discipline. An equivalent combination of higher education and experience will be considered.
  • A minimum of 10 years' experience in a GMP laboratory.
  • A minimum of 2 years' technical experience with flow cytometry, molecular, or cell biology testing.
  • A minimum of 2 years' experience with regulatory inspections (including hosting lab tours).
  • A minimum of 6 years of increasing management responsibility of a cell therapy, drug product, or related biopharmaceutical Quality Control laboratory with a minimum of 2 years' experience with being manager of people leaders.
  • Extensive experience with developing team members.
Preferred Requirements:
  • Advanced degree.
  • Strong decision-making skills.
  • Ability to represent Quality Control during site meetings and global quality control meetings.
Working Conditions:
  • May work in areas that may have strong magnets.
  • May work in areas with exposure to vapor phase liquid nitrogen.
  • May be required to wear personal protective equipment (PPE) and other clean room garments. This may include, but is not limited to: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection.
  • May be required to work in and around laboratories and controlled, enclosed, restricted areas, including clean rooms.
  • While performing the duties of this job, the employee may be required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings.
The starting compensation for this job is a range from $194,000 to $242,000, plus incentive cash and stock opportunities (based on eligibility).

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.
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 our BMS Careers Site .

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical,
pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.