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 Quality Systems Manager in our Brooklyn Park, Minnesota office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager working on the Quality team, you will be empowered to utilize your systems focus and management skills, and a typical day will include:
Lead the Quality Systems department covering Document Control, Training, CAPA, Deviations, Change Controls and Supplier Quality.
EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS:
Manage staff in the areas of Document Control, Training, Supplier Quality and EQMS (Electronic Quality Management System) administrative support.
Lead or participate in supplier audits.
Initiate, monitor and complete change controls related to Quality topics.
Review and approve supplier documents.
Initiate, revise, and review controlled cGMP documents including SOPs, specifications and reports.
Conduct training for site personnel on Quality systems.
Collect data, calculate, and report on departmental performance metrics.
Review and approve controlled documentation.
Interpret and execute operating policies, procedures and directives for the department.
Identify and plan projects/studies/reviews/investigations to address a specific issue. Act as an advisor to specialists executing projects.
Assure quality and compliance of department work product.
Maintain knowledge of current applicable regulatory requirements, including FDA/EU/ICH and other global regulations.
Apply knowledge of cGMPs on a daily basis.
Manage day-to-day operations independently.
Delegate responsibility and projects to Quality Specialists based on their level of judgment and experience.
Meet with individual employees on a regular basis to discuss, prioritize, and assign work and projects.
Meet with functional group on a regular basis to discuss daily work, individual projects and departmental goals.
Independently manage personnel development, annual performance reviews and performance issues with minimal guidance.
Proactively look for ways to challenge specialists and create career opportunities to enhance job satisfaction and improve the department as a whole.
Develop and maintain strong internal relationships both within the Quality organization and cross-functionally.
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.
Good interpersonal skills and be able to work effectively and efficiently in a team environment.
Must display eagerness to learn and continuously improve.
Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
Previous industry experience in a regulated environment.
Ability to adapt to changing tasks and priorities and execute in a timely fashion.
Must have direct experience with Quality Systems within the Life Science industry.
Must be able to communicate effectively with employees, peers and management.
Must be able to read, write and converse in English.
Must be experienced in Microsoft Office applications, especially Word, Excel and PowerPoint.
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
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.