Bristol Myers Squibb Director, Quality Systems, Document, Change, and Risk Management in Devens, Massachusetts
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
Bristol-Myers Squibb is seeking a Director, Quality Systems, Document, Change, and Risk Management to provide oversight and guidance for document, change, and quality risk management activities across the Cell Therapy Network.
The Director, Quality Systems will provide oversite for Cell Therapy Business Process Owners for the Document, Change, and Quality Risk Management (QRM). The candidate will lead complex cross-functional issue resolution by employing a methodical approach to root cause analysis and implementing appropriate corrective and preventive actions. The Director, Quality Systems will evaluate and implement a plan to mitigate process and / or product risks and to educate the facility on risk identification, root cause analysis and investigative measures.
Contribute to the writing, coordination, review, approval and maintenance of the CTD/O/Q QS Procedures (SOPs) and Work Instructions (WI)
Provide QA input to functional groups to evaluate and ensure proper closure of deviations, investigations, complaints, change controls and CAPAs
Assure the deliverables, milestones, and objectives for Quality Systems are developed to ensure success of the program(s).
Ensure that any changes or impact to the systems are communicated and agreed to by the CTD/O/Q sites, teams, and project sponsors.
Superuser role for the Quality Systems that fall under area of responsibility.
Develop and conduct user training for Quality Systems for Above Site personnel. This includes new hire and routine training for Quality System elements of QRM and risk assessment
Support and train cross functional groups with guidance on deviations management to ensure accurate reporting, investigation, root cause analysis and corrective actions.
Perform routine and ad hoc Quality Systems metric reporting and analysis for CTO Management Review.
Prepare metrics and perform periodic trend analysis in support of CTO management review.
Provide communication as to the status of Quality Systems deliverables to customers, management and stakeholders.
Act as QA Subject Matter Expert (SME) to support cross functional groups for Quality Systems functions.
Act as a QA SME during internal, external and regulatory audits
Support internal, external audits and regulatory inspections. (data gathering, interviewing or escorting auditors during the audit)
Participate in the Risk Management program, including updating risk analyses, participating in applicable teams and maintaining Risk Management documents.
Support corporate requests for compliance and regulatory assessments.
Maintains current knowledge of industry standards as it applies to cGMPs and global regulatory guidelines and requirements.
Supports Risk Assessments/projects as required
Qualifications & Experience:
Degree in Biology, Chemistry, Engineering or other related field
Minimum 12 years relevant experience in a cGMP/FDA regulated environment, 4+ years of experience within Quality and Quality Systems
Experience managing a team of 3-5+ direct reports.
Strong knowledge of cGMP Quality And Compliance principles required.
Must possess an independent mindset and have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality Risk Management principles.
Skilled in planning and organizing, decision-making, and building relationships.
Ability to interpret results and situations and articulate recommendations for resolution. Proposes solutions for complex issues and works with management to resolve.
Able to prepare written communications and communicate problems to cross-functional counterparts and management with clarity and accuracy.
Strong cross-functional collaboration experience required.
The starting compensation for this job in Seattle, WA is a range from $173,000-$217,000, 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 the where the job is performed. Final, individual compensation will be decided based on demonstrated experience.
For more on benefits, please visit our https://careers.bms.com/working-with-us .
Eligibility for specific benefits listed on our careers site may vary based on the job and location.
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.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation 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 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: R1566945
Updated: 2023-04-01 03:54:48.625 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.
Bristol Myers Squibb
- Bristol Myers Squibb Jobs