A PROMISE FOR A HEALTHIER TOMORROW

Director, GCP Quality Assurance

Responsible for:

  • Implementing quality assurance audit program across all The Medicines Company (MDCO) clinical trial activities. This includes:
    • development of an annual audit plan;
    • allocation of appropriate audit resources;
    • management of audit conduct and reporting;
    • corrective / preventive action plan (CAP) review, approval and follow up.
  • Design and implementation of quality management plans for all MDCO clinical trial activities.
  • Design/implementation of quality management plans for other relevant MDCO processes (for example, review of promotional materials, review of processes involving CME and IIT activities, vendor management, regulatory affairs).
  • Design and implementation of other quality initiatives for effective and efficient clinical development process
  • Reporting results of quality assurance program to clients and management
  • Provides support during regulatory and health authority inspections of MDCO clinical trials and/or clinical investigator sites participating in MDCO trials; supports other types of inspections as needed.

 

Deliverables:

  • Awareness of best practices in quality management in pharma and other relevant industries for potential application at MDCO
  • Awareness of external environment factors that impact MDCO performance in clinical trials; understand drivers of success in clinical development.
  • Understanding of Quality by Design principles for implementation at MDCO
  • Identifies opportunities for process improvement and/or process re-design
  • Assures that SOPs related to QA are adequate and current
  • Works closely with supply chain quality assurance and MDCO Global Groups of Excellence (GGOE) to coordinate quality management activities
  • Working closely with head of Clinical Operations, determines quality assurance needs for ongoing and planned clinical development projects
  • Educates, as needed, MDCO personnel  and external parties , on GCP  regulation and guidelines and relevant MDCO procedures
  • Acts as a subject matter expert for good clinical practice (GCP) and good vigilance practices (GVP) and provides expert GCP and GVP advice and support to project teams.
  • Works closely with GMP QA organization to promote common QA processes and share results of the QA program
  • Manages, as needed, vendors conducting audits of MDCO projects
  • Management of audit conduct and reporting, including allocation of appropriate audit resources.
  • Establish MDCO as top innovator in quality management in the industry
  • Explores innovative approaches in quality management to achieve MDCO goals
  • Creates effective network within  all relevant MDCO teams
  • Seen as trusted partner by teams and valuable contributor to MDCO projects
  • Responsible spending
  • Ensures projects are on time and on budget
     

Requirements:

  • At least 10 years of experience in clinical research or related field, of which at least 5 years’ experience in QA auditing and / or quality management.
  • Experience in QA auditing in GCP, as well as  other applicable fields such as good laboratory practices (GLP), pharmacovigilance (PV), computer system validation (CSV) and/or good manufacturing practices (GMP)
  • BS or BA in natural sciences
  • Certification/training in applicable quality management disciplines, although not required, are desirable.
  • Solid understanding of quality management and continuous process improvement principles
  • Good written and oral communication skills
  • Excellent knowledge and understanding of GCP and PV regulations and guidelines
  • Understanding of Quality by Design processes and their implementation in clinical development