|

Get new similar jobs by email for

Manager II, Quality Control - ...

Monster
 
 
 
 

Job Summary

Company
Takeda
Location
Boston, MA
Industries
Other/Not Classified
Job Type
Full Time
Employee
Career Level
Experienced (Non-Manager)
Job Reference Code
4314_R0002290

Manager II, Quality Control - Oncology and Biologics

About the Job

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that I agree with Takeda’s Privacy Notice, Privacy Policy and Terms of Use.

Job Description

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 II, Quality Control on our Oncology and Biologics Commercial Quality team in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager II, Quality Control Commercial Quality Operations working on the Quality Compliance team within Release and Stability Management, you will be empowered to ensure Takeda’s products meet all quality standards. A typical day will include:

POSITION OBJECTIVES:

  • Manage oversight of test laboratories at contract manufacturing organizations and contract testing organizations for Oncology & Biologics Commercial products for injectable parenterals and oral solid dose products.
  • Generate release COAs and stability reports and conduct and resolve analytical investigations and deviations
  • Review and/or provide analytical information for regulatory filings and responses to Health Authorities
  • Lead training and on-boarding activities for new QC employees.

POSITION ACCOUNTABILITIES:

  • Ensure release and stability study points are performed on time, the testing is compliant, and that test documentation and results are captured in Takeda electronic systems.
  • Conduct Out Of Specification (OOS)/Atypical (AT) laboratory investigations. Provide impact assessment and drive to closure. Collaborate with GMSO (Global Manufacturing Supply Operations) as needed.
  • Initiate Deviations, Investigations, Corrective/Preventative Actions (CAPA).
  • Initiate Change Controls to change vendor/TPIC specification documents, vendor test methods, stability protocols, and relevant site batch records.
  • Generate product trending for all methods and attributes for each product at each assigned site, including ad hoc trending for deviations and investigations.
  • Generate performance metrics and participate in audits and inspections by alliance partners and government agencies
  • Provide QC representation for regulatory filing team meetings (e.g. Prior Approval Submissions, renewals/updates/supplements, specific LOC requests)
  • Author Annual Product Review (APR/PQR) for QC batch release/stability sections.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • Bachelors or a Masters degree in Analytical Sciences or Life Sciences.
  • Extensive experience in analytical method development, qualification and validation of assays of biologics products.
  • Experience with Bioassays and impurity assays such as FACS Binding, Adhesion, HCP and Protein A is a plus.
  • 10 + years experience in pharmaceutical or biopharma preferred with at least 2 years of supervisory experience.
  • Job related experience in QC specific to release testing review and assessment of deviations/investigations
  • Ability to collaborate effectively with various cross-functional groups within the company as well as with external vendors. Experience with companies outside the US
  • Computer skills preferably include Word, Excel, Trackwise or electronic document repositories. Experience with SAS JMP a plus

TRAVEL REQUIREMENTS:

  • Up to 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.

No Phone Calls or Recruiters Please.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
 

Job Tools