Job Information
Bristol Myers Squibb Associate Director, Quality Assurance Operations in Bothell, Washington
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 .
The Quality Assurance (QA) Associate Director (AD) will be responsible for leading multiple shifts and two sites (Bothell and Seattle), who are involved in the daily activities of manufacturing, assessing and releasing drug products at the Bothell site, and providing quality oversight of Viral Vector Determination Team at Seattle (Dexter). The primary focus of the AD of QA Operations Shop Floor will be to provide quality oversight of GMP operations and ensure compliance with all relevant quality standards and regulations throughout the product lifecycle, from product receipt to release.
The QA AD will also be responsible for overseeing QA activities, ensuring that batch records are reviewed promptly, and that the Quality Management System is effectively implemented, including Quality review and approval of document changes, deviations, change control assessments, and Quality risk management assessments.
The QA AD has a strong understanding of GMP (Good Manufacturing Practices), SOPs (Standard Operating Procedures), and regulatory requirements, as well as proven experience in quality assurance in a pharmaceutical manufacturing environment. QA AD should have excellent communication and interpersonal skills, be a strong leader and able to work collaboratively with cross-functional teams to achieve common goals.
Overall, the QA AD will play a key role in ensuring the continued success and growth of Bothell and Dexter facilities, maintaining the highest standards of quality and compliance, and supporting the development and manufacture of drug products.
Responsibilities:
Responsible for the Quality Assurance oversight of GMP operations at the Bothell Manufacturing site and ensuring adherence to applicable GMP regulations and BMS policies and procedures.
Develop departmental goals and ensure the timely completion of all deliverables, including batch record review.
Champion and foster a positive and successful quality culture, aligned with BMS’s existing culture.
Mentor Quality personnel and enable their individual growth.
Develop a comprehensive understanding of the manufacturing processes and the associated risk management control strategy developed to identify process risks and associated critical controls.
Provide direction and ensure timely guidance to Quality Operations personnel during handling and resolution of GMP events (deviations, non-conformances and corrective action assessments).
Collaborate with stakeholders and management and communicate status to support.
Ensure timely Quality support to site compliance activities such as Change Control impact assessments, root cause analysis during deviation investigations, and development of corresponding CAPAs.
Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of implemented GMP policies and quality management system.
Contribute to the development and execution of BMS Inspection readiness plan at the Bothell Manufacturing site.
Act as subject matter expert for QA oversight of GMP operations during audits and regulatory inspections.
Assists in the design, implementation and continuous improvement of Quality Assurance systems that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
Knowledge & Skills:
Demonstrated experience building and leading exceptional teams.
Experience in FDA/EMA regulation in the biotechnology and/or cellular therapy field.
Experience with implementing and overseeing GMP operations in a plant manufacturing both, clinical and commercial products.
Demonstrated excellence in written and verbal communication.
Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members in a matrixed environment.
Experience in developing/optimizing Quality Systems related to batch records review, Quality oversight of Manufacturing operations, Deviation processes, corrective and preventative actions, strongly preferred.
Proven commitment to quality and continuous improvement.
Basic Requirements:
Bachelor’s degree in relevant science or engineering discipline is preferred.
Minimum of 10+ years working in a Quality within a commercial biopharmaceutical, cellular therapy, or gene therapy organization.
Minimum of 7 years of leadership experience including multi-tiered leadership.
Preferred Requirements:
- Cell therapy experience.
orking Conditions:
Equipment Usage During Work Period: Computer 80%; Phone and Electronic Devices 20%.
Sitting at a computer terminal for an extended period of time.
Regular sitting, standing, talking, listening, using hands & fingers to operate a computer and telephone keyboard reach.
Requirement to work in a conference room / meeting environment for moderate periods of time.
Occasional periods in labs or production area, requiring some level of gowning.
Light to moderate lifting.
Regular, predictable attendance is required, plus occasional overtime, as business demands dictate.
Moderate noise i.e., business office with computers, phone, and printers.
The starting compensation for this job is a range from $149,000 - $188,000, plus incentive cash and stock opportunities (based on eligibility).
The starting pay takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation is decided based on demonstrated experience.
For more on benefits, please visit our BMS Careers site.
Eligibility for specific benefits listed in our careers site may vary based on the job and location.
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.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
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/ (https://careers.bms.com/eeo-accessibility) 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.
Company: Bristol-Myers Squibb
Req Number: R1577503
Updated: 2024-04-26 01:25:12.048 UTC
Location: Bothell-WA
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.