Program Manager, Clinical Quality Assurance

Company: Takeda
Location: Boston
Posted on: November 20, 2023

Job Description:

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Job Description

Job Title: Program Manager, Clinical Quality Assurance

Location : Cambridge, MA

About the role:

As the Program Manager, Clinical Quality Assurance, you will 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 sufficient understanding, experience in GCP and compliance, leadership, communication skills, and business acumen to conduct responsibilities with supervision. You will report to the Head of Gastrointestinal and Inflammation, Clinical Quality Assurance.

How you will contribute:

• 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.
• Provide expertise in GCP compliance interpretation, consultation, training, and recommendations to assigned program teams and leadership
• 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
  
  What you bring to Takeda:
  
  
  • 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.
  • Ability to analyze complex data
  • GCP Quality Assurance registration/certification preferred.
    
    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
    • Tuition reimbursement
      
      Important Considerations:
      
      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:
      
      • Routine demands of an office-based environment
      • Willingness to travel to various meetings and/or audits, including overnight trips. Requires approximately 30% travel. Some international travel may be required
        
        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.
        
        #GMSGQ #ZR1 #LI-MA1
        
        EEO Statement
        
        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
        
        Boston, MA
        
        Worker Type
        
        Employee
        
        Worker Sub-Type
        
        Regular
        
        Time Type
        
        Full time

Keywords: Takeda, Boston , Program Manager, Clinical Quality Assurance, Executive , Boston, Massachusetts