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 I of Oncology & Biologics Quality Compliance in our Cambridge, MA office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager I of Oncology & Biologics Quality Compliance working on the Quality Compliance team, you will be empowered to manage and supervise activities within the Quality Compliance Product Complaint team and a typical day will include:
- The Manager I of Oncology & Biologics Quality Compliance provides personnel and project management for the Quality Compliance Product Complaint Team including management of daily activities within Product Complaint Program and supervision and management of Quality Compliance staff.
- Manage the Product Complaints Program for marketed and clinical products and lead teams in completion of deliverables for Product Complaint investigations.
- Serve as Lead for investigation activities with cross-functional representatives and oversee escalation process for complaint and compliance notifications for the Takeda Boston site.
- Manage activities among staff for support of Quality Product Complaint program during all internal, and Alliance/Corporate Partner compliance or regulatory audits.
- Manages the generation of Compliance data to support reports on departmental Metrics/KPIs.
- Proactively determines strategies and goals for team members, learning plan(s), and development plan(s) for employee(s).
- Serves as Commercial Quality Compliance representative to cross functional project teams.
- Reviews and approves applicable sections of the Annual Product Reviews (APR) and/or Periodic Product Reviews (PQR), as required.
- Primary Trainer of Quality Compliance Staff; provides on-going training, support, guidance and evaluation of staff.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Bachelor s Degree with 6 years of experience or related biopharmaceutical compliance experience
- A minimum of three (3) years people management experience
- Knowledge of cGMP regulations for US, EU and other markets
- Effective time management, detail oriented, organizational skills, teamwork and collaboration
- Strong computer (proficiency in Microsoft Word, Microsoft Excel and Power Point with Track Wise and or Cats Web training desirable), verbal and written communication skills.
- 10% Domestic and/or International Travel possible.
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.
No Phone Calls or Recruiters Please.