Senior Manager, Quality Risk Management, Cell Therapy (R1546643-en-us)
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
PURPOSE AND SCOPE OF POSITION:
This role is part of the site’s Quality Systems team and will primarily focus on developing and managing the Quality risk management program at the Juno, Bothell manufacturing facility. The program is intended to promote self identification of risk areas and implementation of risk mitigation measures for JuMP operations, cGMP compliance and business continuity. Additionally, this role supports the use of various risk management tools to lead complex cross-functional issue resolution by employing a methodical approach to root cause analysis and implementing appropriate corrective and preventive actions.
This individual will serve as the Quality Risk Management business process manager for the site, may also be referred to as the Site Risk Lead.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Bachelor’s degree or equivalent
A minimum of 8 years of relevant risk management experience in a cGMP/FDA regulated environment such as manufacturing/QC or QA.
DUTIES AND RESPONSIBILITIES:
Primary responsibilities include:
- Identify and implement risk management principles, methods and tools and author appropriate policies, procedures, and reports and provide guidance to staff.
- Contribute to the writing, coordination, review, approval and maintenance of the corporate Risk Management Policy and associated Standard Operating Procedures (SOPs).
- Develop and maintain documentation to track key risk information and provide risk reporting to include both quantitative and qualitative risk information.
- Evaluate and report key performance metrics, analyze data and lead improvement initiatives.
- Drive continuous improvement for effective risk management and to address recurring issues identified throughout JuMP.
- Lead, facilitate, coach, mentor and provide technical expertise for root cause analysis and improvement initiatives across JuMP functional areas.
- Track and verify appropriate corrective actions have been implemented, documented and align with source event. - Track the status of risk mitigation actions through to completion.
- Schedule and lead JuMP risk assessment activities to identify risk areas and implement risk mitigation measures to support manufacturing, compliance and business continuity.
- Lead a cross-functional team of associates to assess the integration and implementation of new products and/or processes transitioning to the Juno Manufacturing Plant.
- Facilitate planning, execution and completion of risk assessments by providing direction, and guidance to staff and applicable departments.
- Ensure product risk management documentation/files are maintained, with good documentation practices and in compliances with Juno Quality System.
- Perform risk assessment for incoming Change Control requests.
- Conduct risk reviews and escalate findings, as appropriate, to JuMP Leadership with resolution recommendations.
- Represent the Quality unit at various project meetings and provide quality input in the resolution of quality-related issues.
- Work independently and perform with a high degree of accuracy.
- Partner with other company risk management stakeholders, including Validation, Manufacturing, Clinical Operations, Patient Scheduling, Facilities, and Safety. -
- Apply Federal (FDA) Good Manufacturing Practice (GMP) requirements, guidelines and documentation practices.
- Ensure adequate training of Juno personnel in risk management processes.
- Proactively learn, develop and customize methods and techniques (e.g. Six Sigma/Lean, FMEA, Root Cause Analysis, etc.) to improve effectiveness of the Risk Management program.
- Manage direct reports who support maintenance of the Quality Risk Management program at JUMP, including recruitment and performance management.
- Strong experience and thorough understanding of risk management tools with in-depth knowledge of cGMPs and applicable FDA regulations guidelines and industry best practices
- Proven experience working as a detailed oriented team player with effective planning, organization and execution skills
- Extensive level of experience with performing risk assessments using a variety of tools (e.g. FMEA, FTA, HACCP, etc).
- Innovative, proactive, and resourceful; committed to quality and continuous improvement
- Ability to work effectively at a fast pace with cross functional departments to finalize time-sensitive deliverables
- Able to manage multiple priorities.
- Strong project planning skills.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and 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.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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