Senior Director, Product Quality Engineering
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Job Location:
Seattle, OR - USA
Monthly Salary:
Not Disclosed
Posted on:
19 hours ago
Vacancies:
1 Vacancy
Job Summary
Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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. Read more: Summary:
The Senior Director of Cell Therapy Product Quality Engineering reports to the Executive Director of Cell Therapy Global Product Quality and serves as a key leader within the GCTQ organization. This role leads a global team of quality professionals dedicated to ensuring the highest standards of cGMP compliance product quality and regulatory readiness at BMS.
The Senior Director is accouantable for global standardization and harmonization of product quality principles processes and governance across the cell therapy portfolio. Operating in a matrixed environment this position partners with Global Product Quality Leads and functional leaders to ensure consistent application of GPQ standards risk frameworks and lifecycle strategies. The role drives the vision for platform-based quality approaches and ensures alignment with regulatory expectations and business objectives across clinical and commercial assets.
Key Responsibilities:
Define and implement a global harmonization roadmap for GPQ standards processes and tools across all sites and programs.
Lead a global matrix team of product quality experts influencing without direct authority to achieve alignment across products.
Drive lifecycle platform strategies for Integrated Control Strategy (ICS) Stability analytical lifecycle management jurisdictional control and specification strategy.
Harmonize product quality risk assessment (PQRA) methodologies and robustness metrics across programs.
Ensure all harmonized processes meet global regulatory requirements and support inspection readiness.
Partner with CTTO QA/QC Regulatory and Manufacturing Operations to embed harmonized standards into operational workflows.
Foster a culture of innovation agility collaboration and inclusion within the quality team while maintaining a strong compliance and quality mindset.
Establish and meet ambitious quality performance and compliance metrics in alignment with business and financial objectives.
Lead internal and external governance meetings including steering committees and partner collaborations to ensure alignment and proactive quality management.
Basic Qualifications:
BS MS or PhD in Life Sciences (Biology Chemistry Engineering) or related field with 1215 years of experience in GMP Quality with 7 years in people management and 5 years supporting cell therapy gene therapy or advanced biologics manufacturing.
Demonstrated experience leading global quality teams in a matrixed environment with a track record of hiring coaching and developing technical talent.
Deep knowledge of cGMP compliance regulatory requirements and quality systems in cell and gene therapy manufacturing.
Strategic thinker with strong analytical problem-solving and decision-making skills.
Excellent written and verbal communication skills with an ability to interact effectively at all levels of the organization and with external partners.
Experience supporting technical transfers process qualification comparability and validation for new manufacturing technologies.
Ability to work in a fast-paced environment balancing agility with robust compliance and quality oversight.
Experience driving continuous improvement and supporting business process digitization within quality operations.
Preferred Qualifications:
Experience with autologous CAR T cell therapy viral vector manufacturing and quality control equipment/system automation.
Product Quality Leadership experience for cell or gene therapy/
Track record supporting product launches BLA submissions and regulatory interactions for advanced cell and gene therapies.
Combination of experience in quality assurance quality control and compliance for process development MS&T and external manufacturing.
If you come across a role that intrigues you but doesnt 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.
Compensation Overview:
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 employees 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 offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
Health Coverage: Medical pharmacy dental and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account BMS Living Life Better and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan short- and long-term disability life insurance accident insurance supplemental health insurance business travel protection personal liability protection identity theft benefit legal support and survivor support.
Work-life benefits include:
Paid Time Off
US Exempt Employees: flexible time off (unlimited with manager approval 11 paid national holidays (not applicable to employees in Phoenix AZ Puerto Rico or Rayzebio employees)
Phoenix AZ Puerto Rico and Rayzebio Exempt Non-Exempt Hourly Employees: 160 hours annual paid vacation for new hires with manager approval 11 national holidays and 3 optional holidays
Based on eligibility* additional time off for employees may include unlimited paid sick time up to 2 paid volunteer days per year summer hours flexibility leaves of absence for medical personal parental caregiver bereavement and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours depending on the nature of their work and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors leased workers and other service providers are not eligible to participate in the program.
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 a supportive culture promoting global participation 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 an 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.
Supporting People with Disabilities
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 . Visit to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information: Protection
We will never request payments financial information or social security numbers during our application or recruitment process. Learn more about protecting yourself at data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If you believe that the job posting is missing information required by local law or incorrect in any way please contact BMS at . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.
R: Senior Director Product Quality Engineering
Key Skills
About Company
Bristol-Myers Squibb is a global biopharmaceutical company focused on discovering, developing and delivering innovative medicines for patients with serious diseases. Our medicines are helping millions of patients around the world in disease areas such as oncology, cardiovascular, immu ... View more
