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 Control, Validation and Regulatory Support in our Cambridge, MA office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager, Quality Control, Validation and Regulatory Support working on the Oncology and Biologics Quality team, you will be empowered to lead documentation preparation and analytics activities for the Oncology and Biologics organization. A typical day will include:
- Lead documentation preparation for regulatory submissions (Chemistry Manufacturing, and Controls (CMC) sections for Biologics License Applications (BLA), Licensing Applications (LA), Marketing Authorization Applications (MAA), New Drug Applications (NDA), briefing books, responses to questions from Health Authorities).
- Responsible for delivery of high quality submission-ready documentation.
- Lead analytical and Quality Control activities during the technology transfer and qualification of new manufacturing sites. Review and approve validation documentation; assure high quality of generated results and data integrity.
- Partner with Global Regulatory Affairs CMC, Tech Operations and Supply Operations groups to ensure high quality and timely delivery of submission ready documentation.
- Lead preparation of CMC sections in CTD format for new submissions and post-approval changes.
- Lead compilation of responses to questions from Health Authorities and provide technical expertise for CMC-related questions.
- Review validation documentation, study protocols and reports to maintain compliance and assure high quality of generated data.
- Oversee testing for process validation activities at multiple CROs, as applicable.
- Assure collaborative, proactive, and effective communication with internal teams and external vendors and partners.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Bachelor s Degree in any Life Sciences and 8+ years of relevant experience or Master s Degree in any Life Sciences with relevant laboratory coursework and 5+ years of relevant experience.
- Ability to handle multiple tasks concurrently and in a timely fashion.
- Good knowledge and familiarity with technical writing requirements.
- Understanding of CMC regulatory requirements across major markets.
- Experience with small molecule and biologic products.
- Good interpersonal skills and ability to work effectively and efficiently in a team environment.
- Excellent written, oral and presentation communication skills in English.
- Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
- Willingness to travel to various meetings or training, this could include overnight trips.
- Requires approximately 15% 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.
No Phone Calls or Recruiters Please.