Product Compliance Specialist


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Job Description

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

You Will:

PURPOSE:

  • Support efforts to establish integrated and sustainable Product Compliance strategies and activities for Takeda's products (clinical and commercial) promoting a sustainable existence on the market.
  • Implement collaborative processes with GMSGQ functions and other Takeda Operations and partners to build product quality strategies including Product Quality Review/ Annual Product Review, Governance Forums, Product Quality Assessments, CHO supply, and State Licensing/ Registration support for integrating new product acquisitions into the commercial market.
  • Support management and strategic authoring/ revisions of Compliance Excellence Standards, SOPs, and tools (job-Aid, work instructions) including Product Quality Review, Batch Disposition, Product Hold, Product Discard, Returns, Product Quality Assessment and States Licenses and Registrations.
  • Support and complete product quality assessment to determine the quality health of Takeda products.
  • Support management of state licensing and registration for Takeda products including the Fish and Wildlife license for CHO cells.
  • Support Quality Systems and Compliance projects including product compliance, data integrity, Regulatory Intelligence, inspection readiness,

ACCOUNTABILITIES:

  • You will support global leadership and primary responsibility for design and sustainability of overall Product Compliance strategies and process for Takeda.
  • Provide support and training to local and global employees for Product Annual Review/ Periodic Product Quality Review, Product Quality Assessments, State License and Registration, and Management of Compliance Excellence quality documentation.
  • You will manage Compliance Excellence Standards, Standard Operating Procedures (SOPs), and tools (job-Aid, work instructions) including Product Quality Review, Batch Disposition, Product Hold, Product Discard, Returns, Product Quality Assessment and States Licenses and Registrations.
  • Support Quality Systems and Compliance projects including product compliance, data integrity, Regulatory Intelligence, and inspection readiness.
  • Oversee audit of various reports using working knowledge of quality concepts, and internal procedures and controls (Product Quality Review/ Annual Product Review, Qualifications, Regulatory Submissions)
  • Participate in projects including Quality LOC, Supply Chain, Manufacturing, Regulatory Affairs, and Research & Development areas in the role of contributor, coordinator, or lead.
  • You have strong motivational and conflict management skills expressed in a matrix global environment.
  • You have demonstrated capability to work on multiple projects and works streams simultaneously.
  • Project management and communications skills to convey global project goals and inspire support from both team members and senior management.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Scientific or engineering graduate (BSc, MSc, PhD), preferably complemented by economic education ( MBA)
  • You have increasing managerial experience and responsibility > 3 + years combined with strong technical operations background.
  • Experience must include successful examples of managing global change by influence - without direct resource control;
  • Strong focus on delivering global results and building capability to demonstrate effective governance
  • Fluent in written and spoken English.
  • Strong scientifically with technical expertise to ensure robust analysis of complex product data and the ability to assess that information to make scientifically sound quality risk based recommendations.
  • Working knowledge of Regulations, US and EU Regulations, including cGMPs, and GDPs, including knowledge of Controlled substance standards accommodating for example, DEA, IMB, UK Home Office.

Our Benefits:

  • Comprehensive Healthcare: Medical, Dental, and Vision
  • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
  • 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 and company match of charitable contributions
  • Family Planning Support
  • Flexible Work Paths
  • Tuition reimbursement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

This job posting excludes CO applicants.

#GMSGQ

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Lexington, MA

Grange Castle, Ireland, Vienna, Austria

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


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