Director, Clinical Quality Assurance
Headlands Research
full-time
Posted on:
Location: 🇺🇸 United States
Visit company websiteJob Level
Lead
Tech Stack
Google Cloud Platform
About the role
- Oversee and direct the Quality Department, ensuring its alignment with the broader business strategy and adherence to industry standards, while establishing clear goals and promoting a culture of quality, compliance, and ongoing improvement.
- Communicate, train, and author (when applicable) Standard Operating Procedures (SOPs) including periodic review/revisions of procedures and policies to ensure compliance with regulations and guidelines in both the US and Canada.
- Develop and maintain key performance indicators (KPIs) to evaluate the effectiveness of quality assurance activities and initiatives.
- Conduct and/or oversee annual and monthly quality reviews.
- Support the corporate development team through quality review of potential acquisition candidates.
- Developing and monitoring employee training as applicable to quality, including GCP, IATA, PHI, KnowB4, etc.
- Develop, implement, and maintain an internal review monitoring system and schedule.
- Report out on quality trends and metrics to aide in effective process improvement and risk management.
- Works with Regional Director of Operations, Quality Managers and Site Directors to ensure quality incidents are investigated, root cause analysis is performed, and a CAPA has been implemented and monitored for effectiveness.
- Partners with regional leaders and site teams to identify potential changes and opportunities for process improvement.
- Provide guidance, support, training and interpretation of regulations, guidelines, and policies
- Supports coordination of sponsor audits, regulatory inspections, and mock audits.
- Oversee documentation, reporting and closure of significant compliance and/or site review findings.
- Acts as backup Quality Manager for all sites within the network.
- Serve as the Quality Leader for assigned sites, providing direct hands-on support with quality reviews, audits/inspections, and CAPA resolution to reinforce site-level compliance and readiness.
- Facilitates New Hire Orientation and on boarding in collaboration with HR for clinical operations to specific functions related to quality.
- Develops and implements a mentorship program for new site employees to foster quality across the enterprise.
- Facilitates CTMS training in collaboration with ESource team.
Requirements
- Education - bachelors-degree in business or a health-related field required; master’s degree preferred
- 5 years’ + experience in clinical trials industry (sponsor or site) with experience in managing quality
- 3+ years’ experience leading a team
- Experience with Quality oversight in Canada preferred but not required
- Prior experience authoring site SOP’s preferred but not required
- Fundamental knowledge of US regulatory standards and guidelines for the conduct of clinical trials (ICH GCP, FDA; EMA; ANZ regulations)
- Ability to work in a remote setting with travel required sometimes with short notice
- Demonstrates strong analytical and proactive problem-solving skills
- Strong written and verbal communication skills
- Exceptional organizational skills, ability to multi-task and be detail oriented
- Experience developing and implementing training materials
- Accomplishes work in accordance with scheduled objectives and effectively meets deadlines
- Ability to maintain high degree of professionalism and integrity