Job description / Role
• Supervises and performs routine and non-routine quality assurance audits to include: clinical investigator sites, vendors, process, system, study project and document reviews
• Analyze and evaluate available data and prepare written audit reports of findings and observations to be shared with facilities and senior management as required.
• Keep QA Management up to date with findings and follow up on corrective/preventive actions.
• Assist with oversight, development, and provide input for the development of clinical SOPs.
• Assist developing strategies and policies for the quality program to improve department efficiencies and consistency, and for facilitating feedback to enable operations to take more proactive approaches.
• Assist in the hosting or provide support for sponsor representatives (monitors, auditors, etc.), IRB personnel and regulatory (e.g. FDA, EMA, OSHA, DHHS, etc.) inspectors, as necessary.
• Track and manage documentation regarding regulatory, sponsor and third party regulatory audits.
• Provide guidance to operations staff with respect to ICH and applicable federal regulations.
• Provide input and support as required to operations to ensure compliance to SOPs, GCP and other relevant Good Regulated Practice (GXP) requirements.
• Maintain tracking of status of audits and projects, workload, initiatives and strategies, etc. of quality management activities.
• Tracks and maintains quality event/incident reports such as Root Cause Analysis and CAPAs.
• Supports and actively promotes the organization’s mission and values.
• Execute other duties as may be required by the Director and/or Vice-President, Quality Assurance.
• Attractive Salary Package
• A Bachelor’s degree in the life sciences, nursing or other relevant discipline
• Minimum of 2 years of QA/auditing experience in the pharmaceutical clinical research industry (GCP- focused; GLP a plus) and consumer health research, or an equivalent combination of education and experience, is required
• An in-depth knowledge of U.S. and international standards and guidelines for the conduct of clinical trials is required.
• Familiarity and experience with validation requirements and Part 11 is preferred.
• Must be proficient and up-to-date with existing and emerging regulatory requirements pertaining to pharmaceutical human clinical research and have the ability to communicate the philosophy and rationale that support these regulations;
• Strong proficiency in Microsoft Office programs (Outlook, Word) , Web applications, creating and maintain controls on documents, and creating Adobe files;
• Exceptional organizational skills, a keen attention to detail and thorough follow through;
• Ability to type proficiently (35+ wpm);
• Excellent verbal and written communication skills;
• Well-developed interpersonal skills and the ability to work well independently as well as with co-workers, peers, supervisors and external customers;
• Ability to effectively and efficiently handle multiple tasks simultaneously with precision and adapt to changes in responsibilities and workloads;
• Must be professional, possess a high degree of urgency and self-motivation, and have a strong work ethic
• Must possess a high degree of integrity and ability to maintain confidentiality with HIPAA guidelines, patient matters and other confidential information.
About the Company
Dragon Recruiting is a leading international staffing and recruitment company, head-quartered in London, with further offices all over the globe. Our clients range from numerous well known UK and international businesses. We also represent a wide range of less well known clients - helping them to find staff for their businesses around the world.
As an international recruitment agency, our clients benefit from a vast network of human resource specialists who attract, cultivate and connect organisations to talent in both global and local markets. Our unrivalled
scope of services and global reach allow us to share candidates and roles across borders. With greater coverage and tools, we can ensure our clients and candidates all get the best outcome for their recruitment needs.
With experience of over 3 decades we are recruiting more than 10,000 workers annually to and from the UK, USA and the Middle East and several other Asian countries. We specialize in the placement of candidates in permanent, contract, temporary and interim positions with clients around the world.