Associate Director, Clinical Quality Assurance

Kriya Therapeutics

Kriya Therapeutics

Quality Assurance
United States · Remote
Posted on Friday, June 21, 2024

Who You Are

As the Associate Director of Clinical Quality Assurance, you will be responsible for ensuring the highest quality standards in clinical research and development. Your expertise will contribute to the success of our clinical trials and regulatory submissions.

How You Contribute

  • Quality Oversight: Provide guidance and oversight for clinical trial activities, ensuring adherence to Good Clinical Practice (GCP) standards. Reviews clinical protocols, amendments, clinical study reports, and other clinical-trial related documented.
  • Training: Standard Operating Procedure and Quality Systems Management: Ensuring appropriate curriculum and maintenance of training materials and quality systems for Kriya clinical colleagues. Serve as the author/reviewer for clinical QA Standard Operating Procedures and other documents as necessary.
  • Risk Management: Collaborate with cross-functional teams to identify and mitigate risks related to clinical trial conduct.
  • Audits and Inspections: Prepare for and participate in regulatory inspections, ensuring compliance with global regulations.
  • Vendor Management: lead vendor qualification and work closely with Contract Research Organizations (CROs) to maintain quality standards in outsourced activities. Assist in additional Quality Assurance initiatives as applicable.
  • Biologics Expertise: Leverage your knowledge of biologics drug development to enhance quality processes specific to AAV based gene therapies

What You Bring to the Team

Education & Experience

  • Bachelor’s degree in Life Sciences or related field; advanced degree preferred.
  • Minimum of 10 years of experience in clinical quality assurance within the pharmaceutical or biotechnology industry

Competencies

  • Strong understanding of FDA, EMA, and ICH guidelines.
  • Experience with biologics (a plus).

Working Conditions and Physical Demands

  • Work is normally performed: at a desk
  • Lifting requirements: None
  • Travel requirements: Occasional

About Kriya

Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world.

We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.

What We Offer

Medical, Dental and Vision with 100% employee premium coverage Retirement matching Short and long-term disability benefits 12 company paid holidays Generous Time Off Cyber Safety protection EAP Company paid life insurance Equity and more!

Kriya is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

All job requirements in the job description provided indicate the minimum level of knowledge, skills, and/or abilities deemed necessary to perform the job competently. Job descriptions are an overview of the duties, responsibilities, and requirements of the position. Employees may be required to perform other job-related assignments as requested.