Sr. Manager/Director, Quality Assurance (Real World Evidence/Research Studies) – Top $$/Low Travel
Our client, an RTP area firm that offers real world clinical data solutions to improve clinical, medical, and commercial outcomes, is actively recruiting for a highly skilled and versatile Quality Assurance professional to lead its Real World Evidence QA and Compliance function.
The Company is an innovator in its approach to healthcare research, and is growing rapidly. It conducts disease-focused observational research studies using real world data gathered from clinical sites. We seek a QA expert who will develop, implement, monitor, and maintain quality systems and policies and ensure compliance risks are identified and resolved. Extensive experience with SOP creation and updating will be needed.
This role is low to no travel.
Responsibilities will include:
- Act as the Regulatory and Quality expert for all functional areas of the company, to include strategic quality consultation to senior leadership, cross functional teams and 3rd party partners
- Oversee all aspects of the Quality Management System
- Lead and support internal and external audits:
- Internal quality management system and validated system audits
- Vendor qualification audits
- External (site and vendor) audits
- Third party audits and regulatory inspections
- Vendor supplied data and quality record audits
- Responsible for the development, updating and management of all company-wide Standard Operating Procedures and Working Practice Documents.
- Develop and maintain Good Clinical Practice (GCP) and Good Pharmacoepidemiology Practice (GPP) compliance processes
- Act as the internal expert for QA support and advice for cross functional investigations, projects, third party audits and regulatory inspections
- Provide training in all aspects of the Quality Management System
- Oversee and direct contract auditors.
Targeted candidate will offer a related degree and 8+ years of increasingly responsible roles in QA and Compliance activities in clinical studies. Experience in real world evidence, registries, observational studies, or non-interventional research is strongly preferred.
Other priorities include:
- Familiarity with Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP) and Good Documentation Practice (GDP)
- Expert understanding of GxP regulations and FDA guidelines
- Proactive, smart and deadline-driven organizational skills
- Keen problem-solving, critical thinking and troubleshooting skills
- Experience working with clients and external parties, strongly preferred
Finally, this is a dynamic, empowered, collaborative and mission-driven setting. Seek smart, self-directed and extremely competent professional who can gain the respect and cooperation of colleagues and partners in order to achieve shared success.
This is an immediate need and a Direct Hire opportunity. Please forward Word resume for prompt consideration.