By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionJob Title : Clinical Program Quality LeadLocation : Cambridge, MAAbout the role:You will lead the Clinical Quality Assurance (CQA) activities for assigned clinical development programs, including the management of audits, quality issues and investigations, and inspections.This is a remote role that reports to the Head of Neuroscience, Clinical Quality Assurance.How you will contribute:
Provide expertise in GCP compliance interpretation, consultation, training, and recommendations to assigned high priority development program teams
Assume complex assignments on issues or studies where there is no precedent
Mentor and provide support to Manager level CQA personnel,
Develop and implement program-specific risk-based audit and compliance strategy and manage audits of sites, documents, databases, vendors or internal systems in compliance with GCP and Takeda policies and procedures. Audits require advanced auditing skills and involve technically complex assignments. Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to CQA management. Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures
Lead investigations into quality issues, scientific misconduct and serious breach of GCP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities.
Lead GCP health authority inspections; lead clinical development teams in preparation for announced inspections and provide GCP compliance technical support during inspections of investigator sites and Takeda. Facilitate appropriate inspection responses and follow-up actions
Analyze, report, and present metrics for assigned programs to development teams R&D, and Quality management; recommend any required actions and monitor implementation.
Collaborate with Quality Compliance and Systems team to identify and mitigate GCP quality and compliance issues with potential impact across multiple programs, Takeda sites, or functional groups.
Escalate systemic and critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution
Participate in due diligence activities and process improvement initiatives as requested by management, and may act as supervisor for temporary contractors
Provide professional expertise and guidance on Good Clinical Practice (GCP) and applicable regulations to clinical development teams to proactively identify compliance issues 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; and enable teams to be inspection ready, in support of a culture of sustainable compliance.
Independently manage domestic and international audits of sites, documents, databases, vendors or internal systems in compliance with GCP and Takeda policies and procedures; assess impact of audit findings on subject safety, data integrity, and business operations. Audits conducted require advanced auditing skills and may involve technically complex assignments, including audits of high-risk studies/vendors
What you bring to Takeda:
BA/BS degree required.
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.
Knowledge and awareness of ICH GCP and applicable global regulations and guidance for clinical development.
What Takeda can offer you:
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
Professional training and development opportunities
Tuition reimbursement
Important ConsiderationsAt Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
Travel to various meetings and/or audits, including overnight trips. Some international travel may be required. Requires approximately 30% travel.
More about us: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.This posting excludes Colorado applicants.#GMSGQ #ZR1 #LI-MA1 #LI-RemoteEEO StatementTakeda 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.LocationsBoston, MAZurich, SwitzerlandWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time