Director/Senior Director Clinical Quality Assurance - Tris Pharma

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.

Our science and technology make us unique, but it is our team members that set us apart; they are the engine that fuels Tris’ passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company’s success. But of equal importance to each member of the team is how we interact with one another on a daily basis. We believe in each other, and we believe in respectful, open and honest communications to help support individual and team success. 

Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a full-time permanent Director/Senior Director, Clinical Quality Assurance. This is a hybrid position. Job Title commensurate with experience.

SUMMARY:

Reporting to the Chief Quality Officer the Senior Director of Clinical Quality Assurance provides strategic leadership and direction for Clinical Quality Assurance Operations, ensuring compliance with regulatory standards and driving implementation and continuous improvement of Good Clinical Practices (GCPs). The role partners with Clinical Development, Clinical Operations, Medical Affairs and R&D Quality Assurance to develop and implement quality strategies that align with Tris Development goals and objectives.

ESSENTIAL FUNCTIONS

• Establish and maintain the GCP QA programs, policies, and SOPs.
• Ensure GCP compliance of clinical trials.
• Oversee and manage the qualification and auditing process and other GCP QA inspectional activities.
• Responsible for inspection readiness related to GCP and is the primary liaison with Health Authority and Partners during internal audits and Health Authority inspections.
• Conducts audits at Clinical trial sites and Contract Research Organizations to ensure the compliant conduct of Tris sponsored clinical trials.
• Understand and interpret regulatory agency policies and guidance as it pertains to GCP requirements.

Requirements

QUALIFICATIONS

Minimum education and years of relevant work experience

• Bachelor’s degree in science required, preferably in Biology, Chemistry, Pharmacy, or other medical science.
• Minimum of 15 years of relevant experience in pharmaceutical/biotech industry
• Minimum 10 years of experience in Good Clinical Practice Quality Assurance role, both in a tactical and strategic sense.
• Job Title commensurate with experience.

Special knowledge or skills needed and/or licenses or certificates required

• GCP Subject Matter Expert
• Thorough understanding of global and local clinical trial/study regulatory requirements and processes in both Pharma and Medical Devices
• Experience in developing SOPs , reviewing internal clinical, regulatory, and medical processes to ensure they are accurately represented in SOPs
• Ability to conduct external audits of investigator sites, CROs, supporting laboratories, and monitoring organizations
• Experience with effectively managing regulatory inspections
• Excellent Verbal and Written Communication skills
• Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members
• Analytical thinking with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines 
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
• Fluent in English (verbal and written)  

Special knowledge or skills needed and/or licenses or certificates preferred

• Advanced degree (MS, PhD, MBA) is preferred.
• Experience with Regulatory approval, NDAs and MAAs

Travel requirements:

This position will require some travel both domestic and international periodically up to 25% on annual basis.

Physical requirements

Office based position

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer