Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Head of GCP Deviation Management, Clinical Quality Assurance (Director) in our Cambridge, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to create better health for people, brighter future for the world.
Lead critical and/or major systemic GCP Quality Investigations that pertain to programs, studies, processes, systems, vendors, etc. This includes, but is not limited to, serious GCP breach and scientific misconduct.
Oversee and provide guidance for GCP Quality Investigations conducted by CQA Program Managers and suppliers, as necessary.
Provide input to audit schedules of R&D clinical research processes, systems, vendors, etc. and ensure effective risk mitigation plans are established.
Establish processes, tools and standards for excellence in GCP investigation documentation, inspection preparation and responses, CAPAs, and CAPA effectiveness checks to optimize effective and consistent performance by CQA and R&D team members.
Provide investigational excellence training to CQA & R&D team members to ensure robust investigations.
Host monthly deviation review board meetings with relevant CQA and R&D team members to ensure on time closure of deviations.
Interpret CQA quality metrics for deviations to identify and communicate compliance risks and liaise with R&D and R&D Quality functions to drive organizational process improvements.
EDUCATION and EXPERIENCE:
BA/BS degree required; advanced degree preferred.
Minimum of 10 years of experience in the pharmaceutical, biotechnology or related health care industry.
Minimum 8 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
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 safety and data integrity.
Extensive experience in management of GCP investigations and inspections
Collaborative team player with a positive attitude and ability to think and act quickly to identify creative solutions to complex problems
Effective technical writing skills; able to write quality positions, audit reports, and procedures.
Excellent communication skills with ability to negotiate and influence without authority in a matrix environment
Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines
Superior attention to detail and ability to analyze complex data
Willingness to travel to various meetings and/or audits, including overnight trips. Some international travel may be required.
Requires approximately 10% travel.
This job posting excludes CO applicants.
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.