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 an Asc Dir CQA Program Lead in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Asc Dir CQA Program Lead working on the R&D Quality team, you will be empowered to lead 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) 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; 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
- 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, as needed
- 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
- 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
- May act as supervisor for temporary contractors
SCOPE OF SUPERVISION:
NUMBER SUPERVISED WORKERS
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- 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
- 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 analyse complex data
- GCP Quality Assurance registration/certification preferred
- Routine demands of an office-based environment