Director, Regulatory Affairs and Quality Assurance
OuraFull Time
Expert & Leadership (9+ years)
Candidates should possess a Bachelor’s, Master’s, or PhD in Biotechnology, Chemistry, Pharmaceutical Manufacturing Technology, Industrial Pharmaceutical Science, Pharmaceutical Technology and Quality Systems, Engineering, or a related scientific discipline, combined with at least 10 years of experience in the life sciences industry (Pharma, Medical Device, Biotech, etc.), with a proven track record of leading or collaborating effectively within cross-functional teams. In-depth knowledge of cGMP systems, Quality Assurance, regulatory affairs, pharmaceutical manufacturing, and testing, with direct experience in manufacturing environments is required, and prior experience in sterile manufacturing, biotechnology, medical devices, and/or Cell and Gene Therapy is highly advantageous. Demonstrated technical leadership in the development and implementation of Quality Management Systems (QMS) is also necessary.
The Associate Director QCR will serve as both a strategic leader and subject matter expert, building, expanding, and leading the Practice Area function across Europe, ensuring excellence in service delivery, operational readiness, and execution. They will actively participate in business development activities, including marketing, direct sales, and sales support across various regions in Europe, leveraging their professional network to attract new business opportunities and secure assignments for consultants. The role involves creating and contributing to content that supports industry-leading approaches, consulting clients in the areas of Quality, Regulatory, and Compliance, providing significant support to the Practice Area Leader with respect to quality systems, knowledge management, service definition, and delivery, and engaging in strategic project work. Furthermore, the Associate Director will fulfil Quality, Regulatory, and Compliance roles while managing client relationships, develop and mentor CAI agents through structured professional development plans, and build and maintain strong relationships with EU regulatory authorities and other relevant stakeholders.
Consulting for operational readiness in healthcare
CAI Technical Consulting Malaysia SDN, under the brand cagents.com, offers consulting services focused on operational readiness for clients in the pharmaceutical, biotechnology, and healthcare sectors. They conduct operational readiness assessments to evaluate a company's preparedness and tailor their services accordingly, which include project planning and asset management. CAI stands out from competitors by emphasizing professional development and industry collaboration, ensuring their team stays updated on industry trends. Their goal is to help clients achieve operational excellence and readiness for full-scale production.