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Executive Vice President of Quality
7 days ago
We are looking for an Executive Vice President of Quality to lead our quality assurance team at BioLab Holdings, Inc. As the Executive Vice President of Quality, you will oversee the Quality Management System (QMS) and ensure compliance with all regulatory requirements and industry standards. You will develop and implement a robust global quality strategy, drive a culture of quality excellence, and support initiatives to align the QA function with our strategic goals.
About Our Company
BioLab Sciences is a pioneering regenerative health company dedicated to providing innovative solutions that promote natural healing. Our mission is to manufacture high-quality products that enhance human performance through continuous innovation, education, and exceptional customer service. With a strong commitment to quality, safety, and compliance, we are expanding our market share within the wound management space. We seek talented individuals who share our passion for making a difference and supporting our company's mission.
Key Accountabilities
The successful candidate will have extensive experience in design and development efforts for medical devices governed under design controls, specifically as outlined in 21 CFR 820.30, and will have actively participated in the development of these systems. Key accountabilities include:
- Developing and executing a comprehensive quality strategy aligned with BioLab Sciences' corporate objectives and regulatory requirements.
- Establishing and driving a culture of quality excellence and continuous improvement across the organization.
- Leading the organizational transformation to support medical devices regulated under ISO 13485, ensuring seamless integration with existing regulatory frameworks.
- Developing long-term plans for QA/QC staffing and infrastructure to align with growth forecasts and strategic priorities.
- Developing and administering budgets, plans, and performance requirements linked to the quality assurance and quality control departments.
- Creating a comprehensive Quality Plan with clear deliverables, including performance metrics.
Qualifications
The ideal candidate will have a postgraduate degree in Engineering or Life Sciences and a minimum of 15 years of experience in Quality Assurance, with at least 5 years in a senior leadership role in the pharmaceutical, biotech, or medical device industry. Proven track record in developing and executing global QA strategies, with extensive experience with GMP, GLP, 21 CFR 1271, 21 CFR 820.30 (design controls), ISO 13485, ISO 14971, and international regulatory requirements.
