Director of Quality Assurance & Regulatory Affairs (QA/RA)
Summary
The Director of Quality Assurance and Regulatory Affairs (QA/RA), will be a part of the executive team with the primary responsibility of building and maintaining Quality Systems for a next-generation sequencing clinical laboratory. Inocras is headquartered in San Diego, CA, specializing in whole genome sequencing for cancer and rare disease. This role is strategically important for the success of commercialization goals, ensuring continuous improvement and high-quality assays enter emerging, regulated, and clinical global markets.
You will serve as the subject matter expert to the executive team and provide guidance in areas related to quality, compliance, regulations, and clinical documentation for global registration. By working closely with the leaders of the company across all departments, this position will introduce and lead transformational efforts for improving product quality and driving a culture of quality throughout the company. Continuous improvement and ad-hoc issue resolution to drive improvement of quality operations, at the lowest costs and in full compliance of all relevant
regulations and standards.
This role is ideally suited to a candidate who is self-motivated and excited by an opportunity to rise to frequent and diverse challenges.
Key Responsibilities:
- Responsible for development, implementation, maintenance, and overall success of the company’s quality and regulatory programs and strategies, including articulating quality standards and objectives, developing methods to embed quality into the assay and software development process, establishing vendor relationships and quality standards, and developing and implementing innovative programs to focus employees on improving product quality.
- Develop, implement, and support a comprehensive regulatory compliance strategy to meet global market requirements for our products and ensure alignment with our overall business strategy.
- Proactively partner with R&D, Marketing, and other groups to provide regulatory advice and guidance on meeting necessary requirements to place products on global markets.
- Ensure that regulated processes and systems are always inspection ready.
- Oversee the performance of internal and external audits, including ISO 15189, ISO 27001, State of California as well as CAP and CLIA
- Review, edit, and maintain all departmental policies and procedures, including trainings, CAPAs, NCMRs, Deviations and Complaints.
- Oversee the development of employees, talent, processes, and technology necessary to reach annual and long-term objectives as organizational leader for the QA/RA functions
- Serve as person responsible for regulatory compliance.
Skills & Abilities:
- Extensive experience hosting regulatory inspections and interacting with regulators
- Expertise understanding of CAP, CLIA, GLP, cGDP, FDA, ISO, State of California, CLEP and applicable regulations and industry standards regarding clinical research and regulation of medical devices
- Strong understanding of global registration requirements and demonstrated track record of successful market access.
- Effective manager with ability to mentor and develop members of the QA/RA teams through coaching and effective performance management
- Proven ability to create culture of accountability and ownership
- Proven track record with establishing and maintaining strong internal and external partnerships.
- Must be able to work effectively at all levels in the organization in a matrix environment and with external partners.
- Must demonstrate excellent written and verbal communication skills and work well with diverse teams and stakeholders in multiple locations.
- Must possess the ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities to meet deadlines and prioritize work on multiple projects.
- Highly independent and self-motivated and integrates well within a team.
Preferred Qualifications:
- Bachelor’s degree in a Life Sciences or a related field; advanced degree preferred.
- Minimum of 10 years of experience in quality assurance and regulatory affairs, preferably in the medical, healthcare, or Biotech sector.
- In-depth knowledge of relevant regulations and standards (e.g., ISO, FDA, EMA, etc.).
- Proven track record of successful regulatory submissions and audits.
- Strong leadership and team management skills.
- Excellent communication, negotiation, and problem-solving abilities.
- Detail-oriented with a strong commitment to quality and regulatory compliance.
About Inocras Inc.
Inocras Inc. (Formerly Genome Insight, Inc.) is a precision medicine whole genome platform company with the goal to accelerate the use of whole genome sequencing (WGS) for accurate diagnosis and personalized treatment for cancer and rare diseases. Inocras’ proprietary platform is an automated WGS pipeline coupled with a bioinformatics-powered digital solution that rapidly generates meaningful medical insights making it possible to use WGS in real-life clinical settings. Furthermore, this platform is applied in the research setting to advance novel therapeutic strategies in cancer and rare diseases. The company’s headquarters is in San Diego (US) with R&D offices in Seoul and Daejeon (Korea). To learn more, please visit www.inocras.com
Location: Onsite
Benefits include:
Health, Dental, Vision, and employer covered AD&D policy.
401k plan
Paid Holidays, Sick, and PTO
Compensation
$175,000 - $185,000 annual salary BOE
