Director, Global Quality & Regulatory Affairs
Director, Global Quality & Regulatory Affairs
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$ 150000 - 165000
1 Vacancy
Job Description
Job Details
Description
About Us
Founded in 2011 Fulgent has evolved into a premier fullservice genomic testing company built around a foundational technology platform.
Through our diverse testing menu Fulgent is focused on transforming patient care in oncology anatomic pathology infectious and rare diseases and reproductive health. We believe that by providing a wide range of effective flexible testing options in conjunction with bestinclass service and support we can redefine the way medicine is managed for patients and clinicians alike.
Since integrating with our therapeutic development business Fulgent is also developing drug candidates for treating a broad range of cancers using a novel nanoencapsulation and targeted therapy platform. By merging our fields of expertise we aim to become a fully integrated precision medicine company.
Summary of Position
Job Location: El Monte (Los Angeles) CA OR Coppell (Dallas) TX
The Director of Global Quality and Regulatory Affairs plays a critical role to lead and oversee all quality and regulatory functions supporting our clinical laboratory operations including compliance with IVDR and other global regulatory frameworks. This leader will play a critical role in ensuring that our diagnostic testing products and processes meet all regulatory requirements uphold the highest quality standards and align with our global business strategy.
The Director must be familiar and experienced in CAP CLIA New York / California / Georgia / Texas / Massachusetts State Federal regulations and certification standards IVDR regulations as well as be responsible for ensuring full compliance to all relevant laws and regulations.
Key Job Elements
Regulatory Affairs (Global)
- Lead global regulatory strategies and submissions for clinical laboratorydeveloped tests (LDTs) in vitro diagnostics (IVDs) and companion diagnostics.
- Ensure ongoing compliance with applicable international regulations including:
- EU IVDR
- FDA (21 CFR Part)
- CLIA CAP ISO 15189 ISO 13485
- Other applicable regional regulations (e.g. MolDx CLEP submissions)
- Oversee preparation and submission of technical files and CE marking under IVDR.
- Develop and maintain regulatory intelligence to anticipate changes in the regulatory landscape.
- Lead the organizations transition to full IVDR compliance including gap assessments documentation remediation and notified body engagement.
- Manage planning and execution of performance evaluation plans postmarket surveillance and vigilance reporting aligned with IVDR requirements.
Quality Management Systems
- Lead the development implementation and continuous improvement of global QMS across all lab sites.
- Ensure QMS compliance with ISOand applicable GxPs.
- Oversee internal/external audits inspections and corrective/preventive action (CAPA) programs.
- Champion a global culture of quality accountability and compliance.
Leadership & Strategic Influence
- Lead and develop a global team of quality and regulatory professionals for all lines of business.
- Serve as the key point of contact for regulatory agencies and notified bodies.
- Collaborate crossfunctionally with R&D Clinical Affairs Operations Legal and Commercial teams to support product lifecycle regulatory strategy and lab readiness.
- Act as a thought leader and executive sponsor for regulatory strategy.
Risk Management
- Implement a risk management framework across all processes.
- Reevaluate risk profile when changes are made to the tests or device by updating the FMEA.
Qualifications
Knowledge/Experience
- A bachelors degree with 9 years of experience or a masters degree with 7 years of experience or a Doctoral degree with 4 years of experience preferably in areas of medical devices laboratorydeveloped tests or quality assurance.
- At least 5 years in a senior leadership management role.
- Strong knowledge of Quality Regulatory compliance and operations systems and processes including GMP and QSR requirements for medical devices. (EU IVDR ISO15189 ISO13485 FDAs QSRs CAP CLIA) is required.
- Proficiency in the Microsoft Office suite of products is required.
- Knowledge of domestic and international quality systems and other standards such as FDA QSR ISO15189 ISO 13485 ISO 14971 and other applicable standards and regulations.
Skills
- Prior experience and a strong understanding of quality and regulatory documentation processes and procedures.
- Managementlevel healthcare experience or laboratory regulatory compliance experience essentially including FDA IVDR CAP/CLIA New York CLEP laws and regulations.
- Indepth understanding of compliance operational financial quality assurance and HR procedures and regulations.
- Certification in Regulatory Affairs Certification (RAC) LEAN Six Sigma or Quality certification by the American Society for Quality.
- Proven track record of successful regulatory submissions (eg. IVDR MolDx CLEP) and inspections.
- Strong leadership communication and strategic problemsolving skills.
- Experience managing crossregional teams and global operations.
Reports To
- Vice President Operations & Compliance
Environment
Fulgent Therapeutics LLC is an Equal Employment Opportunity Employer.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. The term qualified individual with a disability means an individual with a disability who with or without reasonable accommodation can perform the essential functions of the position.
Safety and Work Environment:
- General office environment. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
- Maintains a clean neat and orderly work area.
- Adheres to Department Specific Safety Guidelines.
Physical Demands:
- Standing sitting walking bending reaching manual manipulation and lifting up to 10 pounds.
- Must pass a color vision test if responsibilities require color discrimination.
For California residents please see the link below to access our CCPA Privacy Notice.
CCPA Privacy Notice for California Residents
note that Fulgent (and its affiliated companies including Inform Diagnostics and CSI Laboratories) does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Search firms or agencies without an applicable contract and/or express approval to recruit for the role in question that choose to submit a resume or client information to our career page or to any employee of Fulgent will not be eligible for payment of any fee(s) and any associated shared data will become the property of Fulgent.
Required Experience:
Exec
Employment Type
Full-Time
