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Senior Director Clinical Quality Assurance

Company: Intra-Cellular Therapies
Location: Boston
Posted on: August 7, 2022

Job Description:

Company OverviewFounded in 2002, Intra-Cellular Therapies (ITI) is a biopharmaceutical company developing novel drugs, leveraging technology from the lab of Nobel laureate Dr. Paul Greengard, for the treatment of neuropsychiatric and neurodegenerative diseases.
Our mission is to develop innovative treatments to improve the lives of individuals suffering from neuropsychiatric and neurologic disorders, thereby reducing the burden on patients and their caregivers. Patient needs are the core of our efforts.
With headquarters located in the heart of NYC on the Alexandria Center for Life Science campus, we have access to some of the brightest scientific minds in the industry. This has enabled us to assemble a talented and passionate Research & Development team focused on finding innovative solutions for CNS diseases.
For more information please visit the Intra-Cellular Therapies, Inc. website at http://www.intracellulartherapies.com.
The Senior Director, Clinical Quality Assurance (QA) will ensure that planning, coordination, control, and continuous improvement of processes and methods are established to control the quality of studies conducted at ITCI. They will lead teams focusing on continuous improvement projects using approved tools, design control, validations, and ensuring adherence to the agency regulations, GxP, Industry Guidelines, local regulations, along with ITCI policies and procedures for the conduct of clinical trials. This involves working closely with Clinical Operations, Information Technology, and other supporting areas/development teams, to help ensure active participation in continuous quality improvement activities.
If candidate is Boston based, the position will be remote.
Responsibilities:

  • Oversee GCP quality oversight systems through review of SOPs (Standard Operating Procedures) that follow 21 CFR Part 50, 56 and 312 along with ICH E6 and other relevant guidance documents
  • Collaborate with Clinical study teams to ensure that studies are compliant with GCP requirements ---
  • Develop, maintain, and implement internal/external audit programs to meet regulatory requirements, determine compliance status and identify compliance risks
  • Conduct QA reviews of key Clinical Development documents (e.g., protocols, informed consents, investigator brochures, clinical study reports, etc.)
  • Actively lead or assist activities in the areas of Internal Quality Audits, CAPA (Corrective and Preventive Actions), and Quality Management Reviews
  • Lead auditing activities to ensure that studies are conducted in accordance with sponsor protocols, GCP, industry guidelines, and agency regulations.
  • Lead or assist with identifying non-conformances with requirements, provide suitable recommendations and facilitate ongoing quality improvements using risk-based methodology while maintaining compliance
  • Ensure appropriate training to ITCI Clinical staff
  • Complete all company and job-related training as assigned within the required timelines.
  • Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
    Requirements:
    • Bachelor's Degree is required in Biological Science, Chemistry or related technical discipline; Graduate Degree is preferred
    • 10+ years experience in Biotech/Pharmaceutical industry
    • Direct experience with regulatory authority GCP inspections
    • Direct experience in developing and implementing GCP quality oversight systems
    • Direct experience in developing and implementing a clinical site qualification program utilizing a comprehensive GCP auditing system in partnership with the Clinical Operations team
    • Experienced in all phases of drug development
    • Flexible in the face of shifting needs and/or priorities
    • Strong written and verbal communication skills
    • Able to interface well with all levels of personnel, including peers and other department heads
    • Strong computer skills
    • Must be able to perform all essential functions of the position, with or without reasonable accommodation.
      Please forward resume and cover letter for immediate consideration to HR@itci-inc.com
      EOE

Keywords: Intra-Cellular Therapies, Boston , Senior Director Clinical Quality Assurance, Healthcare , Boston, Massachusetts

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