The Director, R&D Compliance and Standards will provide expertise and leadership for GxP and non-GxP compliance and quality activities specifically within the Research Laboratories and Development functions at Kriya. You will also be responsible for driving a culture of quality and overseeing compliance within the functions and will serve as an advocate for the Quality Management System (QMS).
The Director, R&D Compliance and Standards works to ensure that Kriya R&D complies with all internal and external standards (laws, regulations, directives, guidance, etc.) that are applicable to their activities. The Director, R&D Compliance and Standards works closely with R&D functions to anticipate and prevent issues that may impact R&D compliance. This role may support any or all of the responsibilities and tasks listed below. This position reports to the VP, Quality Assurance.
The expectation is that the Director, R&D Compliance and Standards is able to perform the following responsibilities and tasks independently, with minimal direction from management:
- Develops and maintains quality systems and controlled documents
- Educate the teams about good scientific practices and importance of data integrity in the non-GXP laboratory areas by presenting relevant regulations and best practices
- Interpret, analyze, and integrate new and updated regulations and guidance documents
- Communicate quality and compliance risks to leadership
- Reviews R&D documents and provides input from a compliance and standards perspective
- Maintains documentation and tracking of Compliance and Standards activities and communications
- Creates tools and training material to support R&D functions
- Plans, arranges, and/or conducts internal and external audits for non-GLP/GLP, GCLP, GCP and GVP areas
- Support staff with the use of computer systems for managing quality processes (e.g. Electronic lab notebooks, electronic QMS system)
- Lead or assist with vendor selection, qualification, and oversight activities
- Manages audit/regulatory inspection readiness and audits/inspections
- Tracks and communicates vendor Key Performance Indicators (KPIs) and other R&D Compliance metrics across the organization
- Plans and conducts root cause investigations and analyses
- Perform Quality Impact Assessments of Quality Issues
- Identify and monitor metrics to assess the quality health of a functional area and/or process; assist with mitigation plans and continuous improvement
- Facilitate and oversee R&D Quality Risk Management (identification, analysis, evaluation, mitigation, measurement, and reporting of risks)
- Understands and works to a risk-based approach, prioritizing the safety and welfare of human trial participants
Qualifications and Skills Required:
- Bachelor’s Degree, preferably in healthcare, life sciences or clinical research
- 8 - 10 years pharmaceutical or biotechnology drug development experience including 5-8 years GxP QA or Compliance experience
- Previous experience in a GCP and/or GVP role preferred
- Ability to work under pressure and maintain flexibility
- Attention to detail
- Knowledge of 21 CFR 11, 50, 54, 56, 58, 312, and 812 as well as ICH E6R2
- Strong analytical skills
- Professional, proactive demeanor
- Strong interpersonal skills
- Strong written and verbal communication skills
- In-depth understanding of global and local Good Laboratory Practice (GLP) and/or Good Research Practice (GRP) regulations and industry best practices
- Experience leading or executing some or all quality activities including but not limited to Audit, Inspection, Vendor Management, Controlled Documentation, Deviations, Training, Quality Risk Management and Regulatory Intelligence.
- Demonstrated technical understanding of computer systems for managing quality processes
- Ability to influence without authority, successfully implement change management and lead others through change
- High attention to detail including proven ability to manage multiple, competing priorities and to prioritize appropriately
Kriya is an equal opportunity employer.
We celebrate diversity and are committed to creating an inclusive environment for all employees.