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Associate Director / Director, GCP Quality Assurance

Cambridge, MA 02142

Posted: 02/02/2023 Employment Type: Direct Hire/Perm Job Category: Quality and Compliance Job Number: 540453 Is job remote?: No Country: United States

Job Description


Summary of Position:
Playing a critical role within organization, the Associate Director, GCP Quality Assurance will be relied upon as Subject Matter Expert in GCP Compliance with respect to planning, execution and close-out Clinical Studies. The Associate Director, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as varied vendors supporting Scholar Rock sponsored Clinical Studies.
This is a high visibility role and will be directly involved in development and continuous improvement of GCP Quality and overall Quality Management Systems as we grow and mature organizationally. This individual will be responsible for coordinating with key stakeholders to develop/implement processes and systems governing GCP activities.

Position Responsibilities:
Oversight of ongoing compliance of Clinical Studies
  • Act as GCP QA Program Lead while working with internal stakeholders to ensure overall study compliance from risk-based principles. Provide expert GCP consultation within the Scholar Rock organization.
  • Work with internal and external Study Team members and develop and execute strategic plans to identify, mitigate, monitor and report site, study and program level compliance risks.
  • Assist in resolving compliance issues at clinical sites, clinical vendors, and laboratories and provide assessment of the impact of any deficiencies. Escalate issues through the Quality Organization as needed.

GCP Vendor Audits and Oversight
  • Coordinate with the Vendor Audit Manager to ensure auditing of GCP Vendors including CRO, Central and Specialty Laboratories, IxRS/IRT/Randomization vendors, IRB/IECs and other vendors.
  • Coordinate with Study Team members to ensure vendor audits are appropriately scoped and that third-party auditors are provided all the documentation and insights required for successful audit execution.
  • Review and approve submitted audit reports. Ensure audits were performed to internal standards. Ensure proposed CAPAs are adequate and track to closure.



Clinical Investigator Site Audits
  • Manage the  Clinical Investigator (CI) Site Audit program. Coordinate with Study Team members to determine CI sites to be audited per study via risk-based criteria. Coordinate with Study Team members and third-party auditors to ensure CI site audits are appropriately scoped and planned.
  • Review and approve submitted audit reports. Ensure audits were performed to internal standards. Ensure proposed CAPAs are adequate and track to closure.
  • Determine if CI Site audit observations may represent study-wide or program-wide risks and ensure Impact/Risk Assessments and Study-wide/Program-wide CAPAs are adequate.

Quality Management System
  • Coordinate with Senior Management, Functional Area Leads, and third-party vendors, on Inspection Preparation activities including mock inspections, gap assessments, resolution and mitigation of identified compliance concerns. 
  • Provide key support during and after regulatory inspections.
  • Coordinate with Program Leads, Biostatistics, Data Management, Medical Affairs, Pharmacovigilance to develop/implement Phase appropriate procedures to ensure consistency and quality with respect to Clinical Trial support activities.
  • Perform internal audits of processes and functional areas to ensure compliance with GCP, internal SOPs and other applicable regulations.

Required Experience:
• Bachelor’s degree in the Life Sciences with 10+ years in pharmaceutical or biotech drug development. Advanced degree preferred.
• Minimum 5 years of experience in Clinical QA, including both external and internal auditing.
• Demonstrated experience working with clinical trial teams.
• Extensive experience with Global Clinical trial conduct, knowledge and understanding of ICH               E6 (R2) GCP Guideline, FDA Regulations and EU Requirements.
• Previous experience facilitating and/or supporting Regulatory Authority Inspections.
• Direct experience in development and oversight of Quality Management Systems.
• Ability to evaluate and reorganize priorities quickly in a dynamic matrixed setting. 
• Excellent interpersonal skills, personal integrity, professional manner and ability to gain respect and develop good working relationship with cross functional personnel at all levels.
 
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