Director of Quality Systems
3 days ago
Clinovo is seeking a highly experienced Director of Quality Systems to lead our quality operations team. As a key member of our organization, you will be responsible for developing and implementing a robust Quality Management System (QMS) that complies with Good Manufacturing Practices (GMP) and other applicable regulatory requirements.
Key Responsibilities:- Develop and execute a strategic vision for the Quality Management System, aligning it with the company's long-term objectives.
- Manage the development, implementation, and maintenance of the Quality Systems and ensure compliance with regulatory standards (FDA, EMA, ICH, etc.) and industry best practices.
- Lead the maintenance and continuous improvement of the Quality Management System, including deviation, change control, CAPA, and complaint system with the goal of maximizing efficiency, effectiveness, and compliance with all applicable GMP regulations.
- Ensure comprehensive training programs for GMP, GCP, and quality standards are in place and effectively executed.
- Implement and/or oversee the Computer System Quality Assurance & Data Integrity programs for electronic based systems ensuring compliance with 21 CFR Part 11 regulatory standards.
- Ensure site is compliant with global data integrity program expectations.
- Collaborate with regulatory affairs and cross-functional teams to support regulatory submissions, including providing necessary documentation and ensuring compliance with filing requirements.
- Support site preparation for regulatory inspections including personnel preparation and training.
- Bachelor's degree in life sciences, chemistry, engineering, or related field; advanced degree (MS, PhD, MBA) preferred.
- Minimum of 15 years of experience in quality assurance, quality systems, and/or quality operations within the pharmaceutical, biotechnology, or life sciences industries.
- A minimum of 5 years of leadership experience is required.
- Proven experience in managing GMP operations, QMS, including vendor management and CMO oversight.
- Strong knowledge of FDA, EMA, ICH, and other global regulatory guidelines and their application to Quality Operations.
- Experience supporting clinical and commercial stage programs, with a strong understanding of the product lifecycle from development through to commercialization.
- Strong project management, organizational, and leadership skills with the ability to multitask and prioritize in a fast-paced environment.
- Excellent verbal and written communication skills, with the ability to collaborate effectively across functions and at all levels of the organization.
- Demonstrated ability to lead cross-functional teams and manage external vendors and stakeholders.
- Proficiency in using electronic QMS platforms (e.g., MasterControl, TrackWise, Dot Compliance) and Microsoft Office (Word, Excel, PowerPoint).
Clinovo is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are a leading provider of clinical research professionals and have a proven track record with pharmaceutical, biotechnology, diagnostic, medical device, and CRO customers. Our mission is to empower healthcare and life science companies by providing expertise in sourcing and placing top clinical research professionals across a multitude of diverse opportunities.
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