Senior Manager, MSAT Compliance and Investigations

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 Manager is responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply at the

Bristol Myers Squibb Cell Therapy Manufacturing Plant in Bothell WA. The Senior Manager oversees an investigational function of the Compliance and Investigations

(C&I) team under the Bothell Manufacturing Sciences and Technology (MSAT) department. The Senior Manager oversees a team of full time BMS employees and

contractors performing product and / or process impacting root cause analysis investigation and assessment activities. The Senior Manager develops and

enables technical excellence and advanced root cause analysis techniques to ensure thorough investigations into complex events. The Senior Manager ensures

the completion of all deliverables actively removes team barriers for execution and develops long-term strategies to improve efficiency. Work will heavily involve the

use and management of quality records stakeholder relationships with Quality Assurance CTTO Manufacturing Quality Control Product Sciences and cross-site

counterparts. The Senior Manager is a formal people manager within MSAT C&I.

Duties / Responsibilities

Company leader managing a team of BMS FTEs and contractors providing direct support to enable successful and efficient manufacturing operations.

Highly adept in cross-functional collaboration and leading and coaching the team through difficult conversations with cross-functional teams.

Assist direct reports and team members with prioritization and communication of the priorities and escalation to the leadership team. Enables agility in work

structure to support unexpected high priority events.

Identifies and implements effective Key Performance Indicators (KPIs) to drive engagement and performance.

Work with team members to identify barriers to execution identify solutions and execute or escalate for resolution / recommendation.

Drives the design and implementation of efficiency and quality improvements to locally owned programs and procedures. Explores new tools and uses creative

problem solving (e.g. risk-based approaches). Often researches creates proofs of concept and introduces new technical and / or business practices to the team.

With minimal supervision leads multiple projects within the investigation support area and contributes to more complex projects and initiatives for the broader site.

Occasionally leads complex technical project teams and cross-functional teams.

Enforces and masters the team processes supporting the understanding of benefits and tradeoffs of decisions. Frequently challenges the team processes

looking for ways to improve them.

Measurable tactical achievements and 360 feedback highly indicative of confidence in ability to lead initiatives of limited scope. Some measurable

strategic achievements and 360 feedback indicative of confidence in ability to lead mid to high level initiatives and teams.

Strong ability to lead others. Mentors others to accelerate their career growth and encourages them to participate. Always proactively supports other team members

within area capability and helps them to be successful.

Excels in demonstrating multiple BMS values (Integrity Innovation Passion Urgency Inclusion Accountability) and works to address perceived deficiencies.

Begins to demonstrate all BMS values at higher levels with tangible examples of each category.

Qualifications

Minimum of Bachelors degree and / or equivalent combination of education and experience is preferred.

7 years of relevant cGMP experience. Experience in FDA / EMA regulation in the biotechnology and / or cellular therapy field is preferred.

1 years of leadership expereince

Demonstrated proficiency in selection of team and effectively managing personnel issues is highly desired. Proven ability to demonstrate attention to

detail personal and team accountability where it is critical to success.

Possesses excellent compliance understanding. This includes both technical and regulatory requirements.

Understands biotechnology processing the purpose of unit operations clean room design and behavior and microbial control concepts including aseptic

technique.

Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action. Must be able to correlate events

and determine the action plan required to avoid incident recurrence and implement the action plan.

Demonstrate excellence in written and verbal communication.

Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.

Innovative proactive and resourceful; committed to quality and continuous improvement.

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 :

• Bothell - WA - US : $143390 - $173751

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 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 Years 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.

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.

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.

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.

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

Required Experience :

Senior Manager

Key Skills

Compliance Management,Risk Management,Financial Services,PCI,Banking,Cost Accounting Standards,Quality Systems,Research Experience,NIST Standards,Securities Law,SOX,ISO 27000

Employment Type : Full-Time

Experience : years

Vacancy : 1