Bristol Myers Squibb Sr. Manager, Quality Compliance 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 .
This role is part of the site’s Quality Compliance team and will focus on ensuring site readiness and management of internal and third-party audits, as well as health authority inspections (FDA, EMA PMDA, etc.).
- Bachelor’s degree or equivalent
A minimum of 8 years of relevant Quality, compliance,or regulatory experience in a GMP/FDA regulated environment.
Audit experience/ASQ certification not required, but a plus
Management and participation in health authority inspections
Ability to work across functions and deliver results
Strong written and verbal communication skills
Understanding and experience of rest of world Health Authorities and Regulations
Own and maintain audit and inspection management logistics and SME preparation program
Coordinate the end to end inspection readiness activities, including preparation and strategy sessions, instructor led training for subject matter experts, and managing audit and inspection related logistics
Ensure site personnel readiness by scheduling and conducting mock review sessions with subject matter experts
Coordinate cross functional activities focusing on development, review, approval and submission of responses for inspection and audit findings
Monitor and report status of remediation actions resulting from audit and inspection findings and drive efforts to ensure on-time completion
Review, analyze and distribute regulatory inspection data and trending issued by regulatory authorities to ensure proactive compliance across the organization
Develop and manage the inspection readiness annual plan, including identification of anticipated inspections
Coordinate document requests to support Health Authority Submission
Provide support for Biologic Product Deviation Reports and other Health Authority report submissions
Support of site notification to management program
Identification and execution of continuous improvement initiatives within the Quality Compliance programs
The starting compensation for this job is a range from $114,000 - $144,000, 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.
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.
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
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 firstname.lastname@example.org . 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: R1576838
Updated: 2024-03-01 02:39:41.090 UTC
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.
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