Director, Quality Assurance

ClinicalPro is seeking a Director, Quality Assurance for a leading Biotechnology company located in the USA. 

This individual will be responsible for delivering quality and regulatory solutions that help fulfill business demands and US safety, quality, and regulatory standards, this individual will collaborate with internal cross-functional stakeholders. 

Must be eligible to work in the USA.

Responsibilities

• Oversees and coordinates the work of a team of clinical QA Managers, Senior Managers, Directors, and Associates supporting GCP.
• Driving the implementation of a risk-based, scalable, and economical quality assurance and compliance infrastructure.
• Support R&D Quality Risk Management, which may involve tasks like risk identification, CAPA management, and GCP quality counselling.
• Determine the GCP space’s needs for controlled document generation, improvement, and training. Collaborates with other leaders within their roles to cultivate the talent of the future.
• Works at all organisational levels to deliver GCP Quality.
• Contribute to and carry out risk-based auditing techniques for GCP compliance.
• Use cross-functional collaboration to find answers to issues and creates challenges that benefit the entire group.
• Plan and organise inspection preparedness actions to assist the research team or programme.
• Take part in inspections by regulatory authorities.
• Establishes goals for the team and direct reports, strengthens teamwork, and fosters career advancement.
• To completely assist drug development activities, partners with external collaborators, workers, and contract research organisations.

Skills and Requirements

• Minimum of 8-10 years of experience in the industry and Good Clinical Practice (GCP) compliance.
• 10 years or more of experience in management, project management, or supervision.
• Possess the background and expertise necessary to execute the most recent industry best practices.
• In-depth understanding of worldwide GCP regulatory standards and guidelines.
• Recognised as a leading authority on a variety of complicated clinical compliance issues.
• Handling of suspected grave violations and CAPAs/deviations.
• Demonstrates impact outside of the RDQ function, and makes choices on extremely complicated topics using GCP information.
• Knowledge of organising and conducting clinical investigator site visits by international regulatory authorities.
• Executing global projects for process improvement with success.
• Demonstrated managerial abilities.
• Successfully guide and coach people.
• Expertise in promoting a quality work environment.
• Knowledge of CAPA management programmes and audit management.
• Strong interpersonal skills and verbal and written communication abilities.
• A strong sense of organisation and project management.
• Undergraduate degree or equivalent.

Apply

If you’re interested in this position, apply now to send us an updated copy of your CV, or give us a call right away.

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