Title: Clinical Quality Assurance Associate Director
Company: Takeda Pharmaceuticals
Location: Boston, MA
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 Clinical Quality Assurance Project Lead/ Asc Dir in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director working on the R&D Quality Assurance team, you will be empowered to lead Clinical Quality Assurance (CQA) activities for assigned clinical development programs, and a typical day will include:
- Responsible for the management of audits, quality issues and investigations, and inspections. This position requires a depth of understanding and significant experience in GCP and compliance, leadership, communication skills, and business acumen to conduct responsibilities independently.
- Provide professional expertise and guidance on Good Clinical Practice (GCP) and applicable regulations to clinical development teams to proactively identify compliance issues/risks and recommend mitigations
- Liaise with various Takeda R&D functions and external parties including contract auditors and investigator sites to promote a high level of quality and consistency across and within programs; develop the risk-based audit and compliance strategy for assigned programs; assist project teams in implementing corrective and preventive actions;
- BA/BS degree required; advanced degree preferred.
- Minimum of 10 years of experience in the pharmaceutical, biotechnology or related health care industry.
- Minimum 7 years of GCP-related Quality Assurance or relevant clinical trial experience.
- Extensive knowledge and/or awareness of ICH GCP and applicable global regulations and guidance for clinical development
To apply for this position, please visit: https://takeda.wd3.myworkdayjobs.com/External/job/Boston-MA/Associate-Director--Clinical-Quality-Assurance-Program-Lead_R0016399-1
SOCRA Exp: 8/28/2020