Senior Manager, Quality Systems
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 sites Quality Systems team and is responsible for implementation, management and monitoring of the sites CAPA Management program. This individual works cross-functionally and within the network to evaluate system performance and ensure relevant process improvements are identified, documented and implemented to mitigate process, product and / or system risks.
Bachelor degree or equivalent
- A minimum of 8 years of relevant Quality or Manufacturing experience in a GMP/FDA regulated environment.
- Knowledge and experience with deviation and CAPA
- Previous work experience related to measuring quality system performance and data analysis.
- Understanding of Quality Risk Management principles and application within the quality systems
- Strong technical writing skill set and ability to critically review reports while effectively expressing Quality principles.
- Quality and continuous improvement
- Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
- Strong project planning skills.
- Experience interacting with FDA or other regulatory agencies
- Strong knowledge of cGMPs and Health Authority requirements
- Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems)
Role and Responsibilities:
- Provide site-level system information to customers, management and stakeholders regarding the status of Deviation and CAPA deliverables.
- Contribute to the coordination, writing, review, approval and maintenance of associated Standard Operating Procedures (SOPs) and Work Practices.
- Develop and conduct user training for the CAPA system to site personnel.
- Prepare metrics and interpret the data in preparation for support of Site and Global Quality Council. This may require the use of relational databases and / or reporting tools to collate and analyze quality data.
- Monitor and report system health metrics for the CAPA program at Bothell.
- Develop and / or improve routine and ad hoc Quality Systems metric reporting for trending, performance deficiencies and conformance to KPIs.
- Evaluate CAPA data to identify opportunities for operational efficiencies, develop improvement plan and deploy across the site.
- Partner with functional areas and counterparts across cell therapy network in identifying and/or harmonizing metrics that support daily operations of the Quality Management System.
- Support internal and external audits and regulatory inspections and audits
- Support corporate and site-level requests for compliance and regulatory data.
- Represent the Quality unit at various project meetings and provide quality input in the resolution of system-related issues.
- Ensure that any changes or impacts to the systems are evaluated and communicated to the site.
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.
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.
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/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.
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