Award-winning and growing CRO seeks a Quality Assurance Manager to oversee the Clinical Laboratory. This requires 5+ years' experience in clinical research having worked for a CRO in pharmaceutical, biotech, medical device or other life science-based industries. This also requires strong knowledge of GCPs, ICH Guidelines and FDA regulations related to Clinical Research, and prior experience in Clinical Quality Assurance. Other requirements include a working overview of the drug development process, experience in GLPs and GMPS as well as 21 CFR Part 11, and computer system validation. Opportunity offers competitive compensation, benefits, and bonus within a stable and growing organization. Additionally, this opportunity requires US Citizenship or Green Card Work Authorization with 5 days a week onsite in New Jersey, meaning a local candidate or one willing to relocate is a requirement.
Requirements:
US Citizenship or Green Card Work Authorization; located in the US.
Local to client location in New Jersey with the ability to be onsite five days weekly.
BS in Life Sciences or within related area.
5+ years' experience in clinical research having worked for a CRO in pharmaceutical, biotech, medical devices or other life science industries.
Strong knowledge of GCPs, ICH Guidelines and FDA regulations related to Clinical Research; a history of having worked in Clinical Quality Assurance.
A working overview of the drug development process.
Experience in GLPs, GMPS, and 21 CFR Part 11.
Computer System Validation.
Computer literacy in Microsoft Office to include Word, Excel and PowerPoint.
Extensive organizational, communication, writing and time management skills.
Knowledge of ISO 27001 would be helpful but is not a requirement.
Some domestic travel to required locations.
Benefits:
Competitive Base Salary.
10%-15% annual performance-based bonus.
Full Health, Dental and Vision Insurance (Aetna).
401K with up to 6% employer contribution and match.
4 weeks' vacation.
8 holidays.
Life Insurance.
Short and Long-Term Disability.
Continuing Education Allowance.
Local candidate preferred but relocation provided based on individual location and requirements.
Responsibilities:
Overseeing Quality Management for Phase 1/11A Clinical Research Center (CRC), along with the Data Management and Biostatistics Divisions.
Liaising with Operations and Management to design and implement a robust Quality system in compliance with GCP regulations and standards.
Overseeing GCP Quality Systems by planning systematic actions and ensuring activities performed comply with applicable rules and regulations.
Guaranteeing study protocols are followed through the utilization of approved operational procedures.
Reporting quality and compliance KPIs to organizational clinical lab services and corporate management, while ensuring proactive action occurs to drive improvements.
Conducting independent quality study reviews to ensure clinical system audits are performed according to audit plan.
Overseeing and advising on the development of SOPs, Guidelines and others.
Performing external investigational site audits for clients as needed, while ensuring compliance with GCP and ICH guidelines, applicable FDA regulations, SOPS and study protocols.
Hosting regulatory agency inspections and sponsor audits and issuing response to report findings after thorough discussion with operational management.
Working with quality team and management to ensure internal/external audit findings are addressed, and that corrective and preventive actions are implemented.
Leading study, and conducting investigations and non-conformance issues to include developing, recommending, and monitoring Corrective and Preventive Action Plans (CAPAS), while performing effectiveness verification to ensure CAPAs are implemented.
Tracking and trending audit findings and investigations while assessing compliance risks and escalating to site management accordingly.
Initiating and managing quality metrics and trending analysis to present findings to management as needed.
Updating departmental management on new and amended regulations influencing CRC operations, while providing training as needed for ongoing compliance with current quality and industry regulatory requirements.
Reviewing and approving CSV documentation in compliance with internal procedures and regulatory requirements.
Evaluating processes and procedures, influencing quality, and proposing process improvement incentives.
Representing the Clinical Quality Assurance as a part of the management team and for the development of company policies and procedures.