Senior Program Manager/Program Manager, Clinical Quality Assurance
December 11, 2017
Full Time - Experienced
2 Year Degree
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 Senior Program Manager / Program Manager, Clinical Quality Assurance in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Program Manager / Program Manager, Clinical Quality Assurance working on the R&D Quality Assurance team, you will be empowered to develop audit programs and represent the team at GCP QA meetings, and a typical day will include:
Provide leadership and influence to the Takeda Clinical Compound Support QA Program Managers and partner with key stakeholders that are integral to clinical development activities.
Manage Therapeutic Area Programs of a highly complex nature and/or high risk programs including, multiple indications, data safety monitoring boards, endpoint review committees as well as those requiring the coordination of multiple vendors.
Serve as a strategic GCP quality resource providing GCP technical guidance recommendations to development teams
Maximize effectiveness and efficiency in the use of available resources in conducting clinical compound support quality assurance activities.
Leadership & Partnership
Provide GCP QA leadership to drug development teams.
Act as a quality expert to provide GCP compliance interpretation, consultation, training, and recommendations.
Coach, educate and collaborate with external sites and cross functional Takeda staff in global regulatory readiness activities and responses in support of successful marketing applications.
Implementation of Audit and Compliance Programs
Lead domestic and international audits of sites, documents, databases, vendors or internal systems in compliance with the Code of Federal Regulations, local regulations, ICH 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 include the technically complex assignments, including audits of potentially high risk studies/vendors.
Ensure that investigator, vendor, facility and system audits are conducted, identified critical compliance risks are mitigated and communicated to Quality Assurance senior management, and that appropriate corrective/preventative action plans implemented.
Collaborate with Global Clinical Compound Support QA (CCS QA) and all related functional areas to ensure that clinical trial activities are conducted in compliance with Good Clinical Practice (GCP) regulations, the International Conference on Harmonization (ICH) and Takeda Policies and Procedures.
Develop and implement a strategic quality plan for assigned compounds.
Supervise and manage investigations into scientific misconducts and/or serious breach of GCP. Analyze findings to identify root/probable cause. Propose, document and track appropriate corrective actions. Assure reporting of potential or confirmed violations to regulatory authorities.
Assist Takeda R&D during GCP regulatory inspections. Provide GCP compliance technical support during inspections of investigator sites and Takeda facilities. Work with the stakeholders to ensure appropriate and timely response and follow-up.
Collaborate with QA Global Compound Compliance and Quality Systems to identify and mitigate GCP quality and compliance issues with potential impact across multiple compounds, sites, or functional groups including Takeda EU, Takeda Asia, and JDC (Japan Development Center).
Rapidly identify, evaluate, and escalate inadequate responses to CCS QA management
Report GCP Compliance status for Therapeutic Teams
Monitor compliance issues identified across clinical programs. Analyze audit program results, quality issues, and quality investigations in order to optimize global operations and overall global state of compliance.
Provide appropriate risk analysis for key stakeholders
Elevate systemic problems with appropriate recommendations/solutions to upper management for immediate and long-term resolution.
Report metrics for assigned compounds to QA management, clinical staff. Evaluate if CAPA(s) are required and monitor implementation.
Leverage Resources Efficiently and Effectively
Lead systems monitoring and process improvement initiatives that enhance regulatory compliance and CQA operating efficiency.
Ensure reports and corrective actions are developed and completed within timelines mandated in internal procedures.
Leverage global CCS QA Team to drive for on time deliverables and quality service delivery excellence.
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
B.S. in Science, Nursing, or related scientific field.
7 years of experience in the pharmaceutical or biotechnology industry with 5 years of GCP-related Quality Assurance experience.
In Depth knowledge of the applicable global GCP regulations, Good Clinical Practices, ICH Guidelines
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.
Strong knowledge and experience in key Takeda Key Therapeutic areas.
Strong written and verbal communication skills. Able to present with influence to Sr Management and Quality Leadership.
Strong and respectful negotiator and influencer. Demonstrated proficiency in conflict prevention and resolution.
Able to manage multiple complex projects, and demanding timelines
ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence, or SQA Registered Quality Assurance Professional – GCP certification preferred, but not required
More than 30,000 Takeda employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeut...ic areas of oncology, gastroenterology, central nervous system and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.
Takeda Pharmaceuticals U.S.A., Inc. ranks among the top 15 pharmaceutical companies in the United States. Our larger U.S. offices are in Cambridge, MA, Deerfield, IL, and San Diego, CA. Research & Development employees in our Cambridge location focus on oncology, gastroenterology, immunomodulation, biologics, translational research, and external innovation. In March 2016, we opened our newest space at 300 Massachusetts Avenue, featuring 230,000 square feet of state-of-the-art office and lab space.
While Takeda is enjoying tremendous growth as an emerging global leader in the pharmaceutical industry, we remain ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine. In short, we are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!