Director, Clinical Quality Assurance

What You’ll Do: We are looking for an experienced and detail-oriented Clinical Quality Operations (QA) Director to ensure clinical trials are conducted according to Quality guidelines and regulatory requirements. Reporting to the VP, Quality, the Clinical QA Director works to lead the Clinical QA team and organization leadership to maintain Quality standards for our clinical trials.

Responsibilities:

• Management of Clinical Quality team and representing QA at internal and external Clinical meetings.
• Manage collaboration and support of Clinical Operations, Clinical Development, and Data Management teams
• Ensure that all processes contributing to the performance of a clinical trial are conducted according to ICH Guidelines and applicable regulatory requirements.
• Manage and maintain clinical non-protocol quality events in the quality system.
• Prepare and assist in preparing Quality management Review reports and quality trend reports.
• Contribute to Clinical Quality improvement programs.
• Evaluate quality events, incidents, queries, and complaints.
• Keep up to date with all related quality legislation and compliance issues
• Contribute materials for submission to regulatory agencies.
• Ensure regulatory rules are communicated through corporate policies and procedures.
• Utilize guidance documents, international standards, or consensus standards and interpret for guidance.
• Ensure that investigator, vendor, facility and system audits are conducted.
• Communicate any critical compliance risks noted from these activities to senior management/VP GxP Quality Assurance.
• Contribute to the preparation, conduct, and responses to regulatory agency.
• Support review of clinical trial material batch records.

Qualifications:

• Bachelor’s degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, Pharmacy) or a related field.
• Minimum of 12 years of experience with Clinical Quality Assurance in the pharmaceutical industry
• Knowledge of applicable GCP regulations and industry guidance.
• Demonstrated ability to assess risk and prioritize effectively, with the ability to work with aggressive timeframes and adhere to project deadlines in a fast-paced environment.
• Keep current with changes to GxP, FDA, ICH, and OSHA requirements.
• Must have strong organizational skills and exceptional attention to detail.
• Able to work independently and as part of a team.

Location: This is a hybrid position with three days on site at our office in Burlington, MA.