Job Title: Associate Director, Global Medical Quality
About the role:
As Associate Director, Global Medical Quality, you will be empowered to lead Quality Assurance activities for assigned post-marketing research activities performed by Takeda including the management of audits, quality issues and their investigations, and inspections. We ask that you have an in-depth of understanding and experience in both GCP and GVP compliance to conduct responsibilities independently. You will report to the Head, Global Medical Quality Pharmacovigilance and Medical Quality.
How you will contribute:
- The research under Global Medical Quality's oversight is varied. GMQ oversees interventional, observational, prospective and retrospective studies, and Takeda's Post-authorization Safety Studies (PASS). You will need a familiarly with these diverse research designs.
- Provide professional expertise and guidance on Good Clinical Practice (GCP) and GVP (Good Pharmacovigilance Practices) and applicable regulations to post-marketing research activity to identify compliance issues/risks and recommend mitigations
- Liaise with 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 allow teams to be inspection ready, to support a culture of sustainable compliance.
- Manage domestic and international audits of sites, documents, databases, vendors or internal systems in compliance with GCP, GVP, and Takeda 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
- Provide expertise in GCP and GVP compliance interpretation, consultation, training, and recommendations to assigned program teams and. Ensure implementation of strategies to align with governing processes, procedures, quality standards and vendor oversight activities required to maintain compliance with applicable regulations.
- Develop and implement risk-based audit and compliance strategy and manage audits of sites, documents, databases, vendors or internal systems in compliance with GCP, GVP and Takeda procedures. Audits require advanced auditing skills and may 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
- Facilitate investigations into quality issues, scientific misconduct and serious breach of GCP; facilitate identification of root cause and development of corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities.
- Help manage GCP and GVP health authority inspections; lead clinical teams in preparation for announced inspections and provide GCP and GVP compliance technical support during inspections of investigator sites and Takeda. Facilitate appropriate inspection responses and follow-up actions.
- Present metrics for assigned programs to development teams and CQA management; recommend any required actions and monitor implementation.
- Escalate systemic and important problems and recommend appropriate solutions to senior management for immediate and long-term resolution
- Perform additional GCP and GVP related activities upon request by GMQ management, including aspects of vendor qualification.
What you bring to Takeda:
What Takeda can offer you:
At 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:
- Work in a controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body
- No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
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.
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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
USA - MA - Cambridge - Kendall Square - 500Worker Type