Junto HLS is working directly with Leadership at a Top 20 pharma to recruit a Director, Quality Assurance – GCP.
- Ensures the development and implementation of strategies regarding the processes, procedures and quality standards required to maintain compliance to applicable regulations.
- Responsible to develop and implement a strategic audit plan for development program.
- 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.
- Represents business unit and serves as Inspection Administrator during regulatory inspections. Provides strategic organizational direction to assure that responses are timely and appropriate to maintain good standing with regulatory agencies.
- Oversees all GCP/GCLP QA activities (including internal or external audit observations and development of adverse trends) in US and LatAm in order to ensure patient safety and data integrity.
- Identifies and mitigates GCP/GCLP quality and compliance issues with potential impact across multiple compounds, sites, or functional groups.
- Develops and presents periodic reports for assigned project describing compliance trends and identifying areas of potential risk to senior management.
- Determines acceptability of vendors for potential use and provides direction, guidance and strategy for Quality.
- Approximately 20% travel
- Some international travel may be required including overnight trips
- Greater Boston, MA or
- Remote with 1 week per month onsite in Greater Boston
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.