A top-tier pharma has engaged Junto HLS to recruit a Director, Clinical Quality Assurance.
- Provides leadership to the Global Clinical QA function across investigator, vendor, facility, and system audits.
- This position has overall responsibility for the ongoing development and operational success of the Clinical Quality Assurance function. This includes talent development and succession planning, resourcing and budgeting, and alignment of functional initiatives, goals and activities with the larger company Pharmaceuticals Development goals.
- Serves as a senior strategic GCP quality resource for drug development activities, and takes a lead role for the preparation, conduct, and responses to regulatory agency (e.g. FDA) audits of company Clinical Research.
- Provides direction and leadership as Therapeutic Area Global QA Lead to assigned therapeutic area(s) in a matrix reporting environment. Responsible for collaborating with global colleagues as well as other QA/Compliance disciplines to develop and implement a strategic audit plan for the development of all company interventional clinical studies.
- Provides direction to the US Clinical Quality Assurance function to ensure the development and implementation of strategies regarding the processes, procedures and quality standards required to maintain compliance to applicable regulations.
- Analyze audit program results, quality issues and investigations in order to optimize regional operations and overall regional state of compliance. Ensure that activities are conducted and reports written according to applicable SOPs and regulations.
- Greater Boston, MA
If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.