Title:Manager, Quality Systems
Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Manager, Quality Systems in our Brooklyn Park, MN office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager, Quality Systems working on the Oncology and Biologics Quality team, you will be empowered to lead and drive the quality systems department. A typical day will include:
- Drive improvements and compliance with site personnel in execution of Quality Systems related to global metrics.
- Create and conduct trainings for site personnel on Quality systems.
- Set expectations and team goals aligned with departmental goals, weekly accountabilities and drive execution.
- Serve as project manager and act as an advisor for specialists executing projects.
- Initiate, revise, and review controlled cGMP documents including SOPs, specifications and reports.
- Drive improvements and compliance with site personnel in execution of Quality Systems to global metrics.
- Maintain knowledge of current applicable regulatory requirements, including FDA, EU, ICH and other global regulations.
- Collect data, calculate, and report on departmental performance metrics in support of daily operations and Takeda s Quality Council.
- Proactively evaluate opportunities to challenge specialists and create career opportunities to enhance job satisfaction and improve the department holistically.
- Meet regularly with functional group to discuss daily work, individual projects and departmental goals.
- Identify and plan projects, studies, reviews and investigations to address a specific issue.
- Apply knowledge of cGMPs on a daily basis.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- BA/BS with 10+ years or Master s Degree in any Life Sciences with 7+ years relevant experience.
- Proven management experience with multiple reports is required.
- Must have direct experience with Quality Systems within the Life Science industry and in a regulated environment.
- Must be experienced in Microsoft Office applications (i.e. Word, Excel and PowerPoint)
- Good interpersonal skills and be able to work effectively and efficiently in a team environment.
- Must have the following personal attributes: Integrity and Trust, Work Ethic, Sound Judgment, Intellectual Honesty, Pragmatism, Courage and Conviction.
- Wrist and hand motion (e.g. typing, writing)
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires approximately 10% travel.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
No Phone Calls or Recruiters Please.
Brooklyn Park, MN