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 an Associate Director/Director Clinical Quality Assurance in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director/Director working on the R&D Quality team, you will be empowered to provide strategic leadership to the Takeda Clinical Quality Assurance Program Managers and partner with key stakeholders that are integral to clinical development activities, and a typical day will include:
- Contribute to the design and implementation of Takeda s risk-based GCP audit and compliance oversight activities.
- Monitor effectiveness of GCP processes through risk-based audits and GCP compliance activities, and provide actionable data to Senior Management based on identified compliance issues and trends.
- Oversee and provide necessary support for the GCP components of Regulatory Inspections.
Leadership & Partnership
- Develops and implements a strategic audit plan in collaboration with R&D Global Compound Support Leaders.
- Maximizes effectiveness and efficiency in the use of internal and external Compound Support resources.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- Bachelor s Degree required; Advanced Degree preferred.
- Minimum 8 years of experience in the pharmaceutical or biotechnology industry with 6 years of GCP QA experience
- Minimum 5 years managing teams in a matrix team environment or managing people.
Knowledge and Skills:
- Advanced knowledge and demonstrated experience in the applicable GXP regulations, FDA Good Clinical Practices, ICH Guidelines, Global Drug Development Regulations and Guidances and Computer System Validation
- In-depth knowledge of drug development processes and GCP regulations
- Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to subject protection and data integrity.
- Demonstrated ability to effectively organize and execute tasks
- Strong verbal and written communication (including presentation) and customer management skills.
- Demonstrates proficiency in negotiation and conflict resolution.
- Computer proficiency
- ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence, or SQA Registered Quality Assurance Professional preferred.
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Carrying, handling and reaching for objects.
- Takeda is a global company. Travel is a requirement of the position.
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.