About Sention Therapeutics, LLC
Sention Therapeutics is a biopharmaceutical company committed to developing therapies that improve the lives of patients suffering from hypothyroidism.

Position Summary

The Senior Director, Clinical Quality Assurance is responsible for the GCP Quality Assurance program ensuring clinical trials are conducted in accordance with GCP regulations and ICH guidelines. Primary responsibilities include management and oversight of all quality aspects of clinical trials, including clinical protocols, informed consent forms, clinical study plans, and support for GCP compliance audits as appropriate. Provides project teams and customers quality/compliance guidance that is commensurate with the stage of development while mentoring and developing staff, conducting GCP training, participating in the selection, qualification and oversight of third party GCP contract service providers, and ensuring development of internal and external audit plans.

Essential Duties and Responsibilities

• Ensure compliance of drug development activities to applicable quality and regulatory requirements
• Schedule and prioritize workload of staff to ensure timely review and release of clinical documents to support corporate timelines
• Oversee the clinical vendor qualification program including quality agreements and the appropriate change control and coordination of documents to all third-party contract providers and business partners
• Develop and maintain clinical quality procedures to ensure sound scientific input and quality is produced in clinical documents (e.g., clinical study plans, clinical protocols, and informed consent forms)
• Develop and report metrics describing the performance against internal quality measures and status of compliance gaps on a regular frequency to the development leadership team
• Review and approve scientific protocols, technical reports, and other documentation in support of drug development, validation including computer validation activities, and regulatory submissions as appropriate
• Support preparation, coordination, and management of regulatory agency inspections, including sponsoring/monitoring inspections and clinical investigator site inspections
• Support audit program as requested by the Head of Quality Assurance
• Support the administration of the company’s training program by ensuring GCP training is provided to clinical team members
• Supervise, mentor, and develop professional quality staff
• Represent clinical quality at operational and cross functional meetings
• Execute other duties as assigned

Qualifications

• Bachelor’s Degree in a scientific discipline required
• Minimum 10 years of progressive experience working within a clinical, regulatory, or quality environment in the pharmaceutical or biopharmaceutical industry required
• Minimum 7 years of direct experience managing clinical quality required
• Must have complete and thorough understanding of GCP regulatory compliance requirements for US FDA, European Union, and Health Canada
• Excellent knowledge and interpretation/implementation of GCP regulations, worldwide regulatory guidelines regarding clinical development, auditing techniques, and document management
• Prior experience with audits and regulatory agency inspections, both US and global
• Prior experience in leading, managing, and conducting compliance audits
• Practical understanding of regulatory compliance requirements with the ability to provide applicable guidance to team members and identify compliant solutions in challenging situations
• Proven management skills with ability to lead and mentor others effectively and experience in advocating a quality environment
• Strong verbal and written communication skills, and ability to establish collaborative working relationships with internal and external stakeholders
• Must be willing and able to travel domestically and/or internationally up to 25%