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 a Clinical Quality Assurance Program Manager in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Program Manager working on the R&D Quality Assurance team, you will be empowered to lead Clinical Quality Assurance (CQA) activities for assigned clinical development programs, and a typical day will include:
- Lead the management of audits, quality issues and investigations, and inspections. This position requires sufficient understanding, experience in GCP and compliance, leadership, communication skills, and business acumen to conduct responsibilities with supervision.
- Provide 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.
- 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.
- Under supervision, provide expertise in GCP compliance interpretation, consultation, training, and recommendations to assigned program teams and leadership
- Under supervision, 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.
- 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
- Assist with 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.
- Provide GCP compliance support during inspections of investigator sites and Takeda. Assist with development of appropriate and timely inspection responses and follow-up actions
- Collaborate with Quality Compliance and Systems team to identify and mitigate GCP quality and compliance issues with potential impact across multiple compounds, Takeda sites, or functional groups.
- Analyze, report, and present metrics for assigned programs to development teams and CQA management; recommend any required actions and monitor implementation.
- Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution
- Perform additional GCP related activities upon request by CQA management
- BS/BA degree required; advanced degree preferred.
- Minimum of 5 years of experience in the pharmaceutical, biotechnology or related health care industry.
- Minimum 2 years of GCP-related Quality Assurance or relevant clinical trial experience.
- Knowledge and/or awareness of ICH GCP R2 and applicable global regulations and guidance for clinical development
- Knowledge of 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
- Effective technical writing skills; able to write quality positions, audit reports, and procedures.
- Strong communication skills with ability to negotiate and influence without authority in a matrix environment
- Solid 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
- Willingness to travel to various meetings and/or audits, including overnight trips. Some international travel may be required.
- Requires approximately 30% travel.
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- 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
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