Takeda Pharmaceuticals Associate Director, Clinical Quality Assurance, Gastrointestinal and Inflammation (Remote) in Dover, Delaware
Job Title: Associate Director, Clinical Quality Assurance, Gastrointestinal and Inflammation (Remote)
Location : Cambridge, MA
About the role:
Responsible for leading Clinical Quality Assurance (CQA) activities for assigned clinical development programs, including 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), medical device regulations and other 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; 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
How you will contribute:
Provide expertise in GCP and medical device compliance interpretation, consultation, training, and recommendations to assigned high priority development program teams
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 significant 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 and timely inspection responses and follow-up actions
Assess and improve our overall processes and systems for utilizing medical devices in clinical trials
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/or 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
Assume complex assignments on issues or studies where there is no precedent
Mentor and provide support to Manager level CQA personnel, as needed
May act as a supervisor for temporary contractors
What you bring to Takeda:
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 and medical device experience.
Extensive knowledge and/or awareness of ICH GCP, medical device 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.
Collaborative team player with a positive attitude and ability to think and act quickly to identify creative solutions to complex problems
Strong 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
GCP Quality Assurance registration/certification preferred
Routine demands of an office-based environment
Willingness to travel to various meetings and/or audits, including overnight trips. Some international travel may be required.
Requires approximately 15% travel.
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
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 environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
Work in a cold, wet environment.
Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
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.
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.