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

Responsibilities:

• Act as designated Clinical Quality representative at internal and external Clinical meetings.
• Collaborate and support clinical operations, clinical development, and data management teams as the Quality representative
• 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 trending 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 8 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.