The Director of Quality Assurance leads all aspects of Quality Assurance efforts of CRO activity, development, implementation of CRO Quality Management Systems (QMS) to maintain company and industry best practices with a focus on clinical quality assurance, Good Clinical Practices (GCP) and overall compliance.
- Member of senior management team engaged in developing key company strategies to meet company goals and objectives, serving as executive oversite and project director roles.
- Provide input on company procedures and policies, ensure and maintain industry compliance with applicable regulations, GXP, ICH and other regulatory and compliance requirements.
- Develop and facilitate company training requirements and training programs by department.
- Identify gaps in SOPs and ensure robust procedures are developed, implemented and meditated.
- Review and/or contribute to development applicable SOPs and quality assurance guidance document and processes.
- Manage the SOP revision and distribution process according to established timelines, guidelines and procedures, including document control standards and electronic filing.
- Develop and maintain company audit plans and schedules (with appropriate input from Clinical Operations leaders)
- Responsible for client audits, vendor selection audits and regulatory inspections.
- Utilize approved QMS systems to identify and address non-compliance trends.
- Library management of paper and electronic documentation, controlled forms.
- Integrate and streamline clinical study partnered services into QMS planning and implementation.
- Communicate cross-functionally with other department leaders to ensure the proper implementation and maintenance of QMS throughout conduct of all clinical studies and associated systems, including Trial Master File (TMF) organization and management.
- Manage and ensure training requirements and records for CRO staff and study teams as appropriate
- Manage company CAPA program by overseeing issue identification, processing, documentation, resolution, and closure.
- Test departmental objectives to ensure alignment with functional and corporate objections.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Fluent in English (both written and verbal).
- Excellent computer skills (Microsoft Word, Excel, Outlook, etc.).
- Thorough knowledge of drug development, the project management process, FDA regulations, and ICH/GCP guidelines.
- Strong understanding of Quality Assurance practices, systems, and software, Veeva platform helpful
- Knowledge of global regulatory agencies and respective laws and guidelines.
- Proven track record of establishing and management Quality Management Systems.
- Excellent communication skills and demonstrated ability to manage and retain direct reports
- Work within and maintain company and departmental budgets
- Ability to lead by example, inspire teamwork, and motivate staff.
- Ability to work with CRO clients in a professional manner.
The above qualifications may be gained through completion of a bachelor’s degree (preferably in health science) with a Masters or other advanced degree preferred. Applicant must also have a minimum of ten years of experience in the clinical pharmaceutical industry, including demonstrated competency in Quality Management Systems (QMS), QA compliance, Quality Assurance, and Quality Control