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Change Management Project Manager, Quality Systems - Bothell Washington
Company: Disability Solutions Location: Bothell, Washington
Posted On: 05/04/2024
Working with UsChallenging. 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 .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, there's no better place than here at BMS with our Cell Therapy team. The primary focus of the Change Management Project Manager role will serve as a key resource to support the Change Management program at the Bothell Site. This includes metric gathering, providing site guidance, and administrating site change control governance meetings. This role will also be responsible for the change management activities at the Bothell site. This position works cross-functionally to ensure compliance with the Cell Therapy global change management program. Additional activities may be required by the Project Manager to support the Quality Systems program at the Bothell Site.Shift Available: - Monday - Friday, Onsite Day ShiftResponsibilities:
- Responsible for working cross functionally helping teams structure change controls and actions (gating).
- Working with global network and owning implementation of global changes.
- Facilitating process improvements to the site change control process.
- Facilitate change control instruction and guidance to change teams.
- Assisting local process owner with metric analysis and creation for change management.
- Working cross functionally with teams to provide change management guidance.
- Establish and maintain relationships with stakeholders, providing timely guidance and status updates.
- Responsible for gathering site metrics including providing annual APQR change control data.
- Work with Sr. Manager of Change Management with providing site training.
- Draft and review site change management guidance documents and work practices.
- Administrate scheduled and ad-hoc change management governance meetings including scheduling, building agenda, and issuing meeting minutes.
- Facilitate the closure of change control records within the quality management system.
- Perform ad hoc duties as required in support of all of the Quality Systems at the Jump site including, but not limited to the following:
- Support internal and external audits and regulatory inspections. This may require data gathering, interviewing or escorting auditors during the audit.
- Identify and implement continuous improvement opportunities for Quality Systems.
- Facilitate cross-functional team meetings.
- Process, author, review, and approve QMS (Quality Management System) documents in the electronic document management system.
- Provide communication on the status of deliverables to customers, management and stakeholders.Knowledge & Skills:
- Extensive experience leading simple and complex projects from planning through full implementation successfully identifying project scope, action scheduling, impact assessment, risk mitigation and implementation plans
- Experience in quality management system (change management, deviation, CAPA, and risk management) processes is preferred.
- Strong technical writing skill set and able to critically review documents while effectively inputting and expressing Quality principles.
- 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.
- Strong knowledge of cGMPs and regulatory requirements
- Must be able to self-direct, multi-task, and clearly communicate to the manager of decisions outside of established processes and the ability to build a cross functional network.Basic Requirements:
- Bachelor's degree or equivalent certificates and experience will be considered.
- 5-7 years of experience in GMP.
- 5-7 years of experience in change management.
- 5 years of experience within a Quality role.
- 3-5 years of experience in Project Management.Working Conditions:
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