Director of Quality Assurance – Remote
Our Cardiovascular CRO is expanding and looking to add a Director of Quality Assurance to their team who would be responsible for the development and oversight of corporate compliance primarily of quality system processes (the quality management system, QMS). This role provides project teams input for good clinical practice, 21 CFR Part 11 and ICH E6 responsibilities and independent review of clinical data for quality assurance signals. This individual serves as a corporate resource for quality assurance related issues.
The Director will be responsible for:
1. Act as a liaison between clients and the company regarding quality and regulatory issues.
2. Be responsible for the oversight and/or conduct of internal and external quality audits and provides suggestions and coordinates quality improvement initiatives throughout the company.
3. Will host external auditors, including the management of the audit preparation, execution, and report response. Specifically, this includes oversight of corrective action completion in a timely manner as well as the verification of implementation and reporting back status and trending to management in a clear dashboard of metrics.
4. Responsible for the investigation of client quality related complaints, the initiation, investigation, corrective actions, and preventative actions required by complaints, or audit findings.
5. Has oversight of change control processes, and controlled compliance documents, and training.
6. Provides support and oversight for SOP review and development including the drafting, revision and updating of Quality Assurance SOPs and other documentation.
7. Will manage hosting, execution, and response development for inspections by Health Authorities in CRO and client activities as described above.
8. Additional Responsibilities
- Manages team of junior QMS associates
- Advises Management on key regulatory and QA issues
- Works directly with Department Heads in the development of new policies, and updating of current procedures and work instructions to ensure the quality of clinical trial process and data.
- Reviews documents for regulatory submissions; clinical protocols, investigator brochures, IND/IDE amendments, IND safety reports, annual and clinical study reports, as applicable.
- Verifies and maintains training records for the company
- Conducts annual Management Review meetings with senior management to discuss and address compliance issues, develop, and review quality initiatives in support of continuing process improvement.
- Five or more years’ QMS management experience
- Thorough understanding of quality systems and GCPs/GCDMs
- Master’s degree and 4 years’ experience or Bachelors / BS degree and 7 years’ experience in the medical or life sciences, QA or clinical research experience or equivalent experience.
- Experience as an GCP-based auditor in the US and EU regulatory environments
- Demonstrated experience with commercial QMS systems
- Strong interpersonal skills for interactions with internal and external clients
- Flexibility and organization at management level is required