Manager, Quality Compliance

1 week ago

Bothell, Washington, United States Bristol-Myers Squibb Full time

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 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:
.

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, theres no better place than here at BMS with our Cell Therapy team.


Our Manager, Quality Compliance is part of the sites 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.).


Shift Available:

  • Monday - Friday, Day shift. This is a hybrid role with the understanding during audits, it will be onsite the entire audit.

Responsibilities:

  • 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.
  • Support inspection readiness and compliance at Dexter site (VVDT).
  • 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.

Knowledge & Skills:

  • 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.

Basic Requirements:

  • Bachelor's degree or equivalent certificates and experience will be considered.
  • 5-7 years of experience within a regulated environment.
  • 3 years of experience within a Quality role.
  • Previous participation in audits.

Preferred Requirements:

  • ASQ auditor certification.


The starting compensation for this job is a range from $92,000 to $115,000, 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 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.


_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._

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

. Visit )

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: R

Updated: :57:24.418 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.

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