The Director Quality Assurance is a quality professional within Linical responsible for the development and implementation of risk-based Good Clinical Practice oversight within Linical processes. This includes identification of risks, communication of risks to the organization, and working in a cross-functional team setting to mitigate the risks.

The Director Quality Assurance is responsible for supporting Clinical Operations, Data Management, Pharmacovigilance, Vendor Management, Regulatory Affairs and other functional areas as needed to ensure the effectiveness of GCP processes, conduct GCP audits, and supporting the development, tracking, and trending of Quality Metrics and creating and presenting actionable reports.

The Director Quality Assurance is responsible for the preparation and hosting of Sponsor audits and regulatory authority inspections as needed and for working with cross-functional project teams to ensure support for each audit or inspection activity.

Duties and Responsibilities:

• Support the Quality Assurance department in maintaining Linical’s Quality Management System (QMS) for all Linical services including:
• Conduct of audits (systems, documents, TMF, clinical sites, vendors)
• Follow-up of corrective and preventative actions (CAPA) and deviations
• Supervision of SOP revisions
• Review of SOPs in cooperation with the operational staff to ensure compliance with GCP and regulatory requirements
• SOP-management (access control, notification of employees, tracking, etc.)
• Vendor qualification and management of related documentation
• Improving of standard and process for quality and efficiency
• Computer system validation/verification
• Management of amendments concerning Monitoring changes in the legal basis of clinical trials, including international guidelines with appropriate implementation into the quality management system
• Oversee the qualification efforts for the selection of third-party vendors
• Provide support prior to and during regulatory inspections by authorities and audit performed by Sponsors on Linical
• Consultancy for operational staff in quality, procedural, and regulatory related questions
• Management of contracted QA services within the area of project responsibility regarding project quality, timelines, and budget in alignment with the overall project management
• Oversee computer system validation/verification activities in cooperation with process and system owners

Required Skills and Abilities:

• Excellent command of written and spoken English
• Ability to work independently and build strong, trusting working relationships with all departments and clients
• Skilled in advising team on quality and compliance matters
• Ability to familiarize oneself with specific indications, symptoms, and study designs
• Very good knowledge of standard office software
• Disciplined work approach
• Strong skills in communication, problem solving, and attention to detail

Education and Experience:

• University or college degree (or equivalent) in a medical or life-sciences related field
• Minimum 10 years experience in clinical research, biopharmaceuticals, or related field
• Minimum 10 years in a senior Quality Assurance role with experience maintaining a quality management system
• Very good knowledge of GCP principles and related US, European, and other international regulatory requirements for the conduct of clinical trials
• Practical experience in clinical trial planning, conduct, evaluation, and reporting
• Practical auditing experience
• Practical experience managing SOPs and the revision lifecycle
• Strong leadership, communication, and people management skills