CDMO Production Quality Assurance CMC Manager
VectorBuilder (VB) is a leader in the ever-emerging Gene Therapy sector, VB are dedicated to delivering high-quality products/services to our customers worldwide and enabling Drug Developers to reach patients faster. With a strong manufacturing capacity in China and a commitment to being compliant for clients from all geographies, we are seeking an experienced Production Head - Quality to join our team and ensure that our products meet the highest international standards, particularly in the EU, UK, and US markets.
VB are looking for a bilingual candidate (Mandarin) who can assist our CTO/VP of Manufacturing and the wider CDMO team in the UK. You will help optimize the way the team works via effective translation of difficult topics related to manufacturing and Quality and how we disseminate information from Production in GZ to the Western teams and ultimately clients/markets.
As the Production Head - Quality - you will play a critical role in ensuring and transferring our products meet and exceed the manufacturing and regulatory requirements in China, the EU, UK, and the US. You will be responsible for developing and maintaining a robust quality assurance system that adheres to international standards and best practices. Your operational expertise will be pivotal in safeguarding our reputation for excellence in quality and compliance. As the business grows this remit may change from time to time.
- We will expect at least over 5 years hands-on experience at variant levels of managing roles in pharma/biotech in a technical operations/ Manufacturing role, including supervising production management of more than one facility if possible.
- For regulatory submission, clinical approval or IND-enabling/approval experience is required while experience in BLA or MAA is a plus.
- Experience as a manager in pharma/biotech in a technical operations / QA / Manufacturing role and dealing with a wide range of personality types
- Experience managing client relationships across geographies
- Experience with CDMO manufacturing/service agreement contracting/CRM
- Experience supporting biologics CMC regulatory submissions
- Ability to lead scenario planning, options analysis, risk management activities
- Experience in working with multidisciplinary teams.
- Highly organized and capable of leading / pursuing multiple projects independently
- Experience with GMP requirements and interfacing with QA (Quality Assurance), technical teams, external collaborators highly desired.
- Experience of planning and qualifying a new facility would be a plus.
- Regulatory Compliance: Ensure that all products and processes comply with relevant regulations and standards in China, the EU, UK, and the US, including but not limited to [list specific regulations and standards relevant to your industry].
- Quality Management: Develop, implement, and maintain a comprehensive quality management system that spans all aspects of the company's operations, from product development to distribution.
- Audit and Inspection readiness: Prepare for and manage audits and inspections by regulatory authorities and external agencies. Ensure all findings are addressed promptly and effectively.
- Cross-Functional Collaboration: Work closely with cross-functional teams, including R&D, Manufacturing, Supply Chain, and Legal, to integrate quality and compliance into all processes and decision-making.
- Risk Assessment: Identify potential risks related to quality and compliance and develop strategies to mitigate them.
- Training and Development: Lead training initiatives to ensure that all employees understand and adhere to quality and compliance requirements.
- Documentation and Reporting: Maintain accurate and up-to-date records of quality and compliance activities. Generate reports for senior management as required.
- Continuous Improvement: Drive a culture of continuous improvement, identifying opportunities to enhance quality and compliance processes and systems.
- Market Knowledge: Stay updated on regulatory changes and market trends in China, the EU, UK, and the US that may impact our products.
- Bachelor's degree in a relevant field (advanced degree preferred).
- Minimum of 5 years of experience in CMC/quality assurance and regulatory compliance in Cell/Gene Therapy or a mixture of these.
- Extensive knowledge of regulatory requirements in China, the EU, UK, and the US.
- Strong leadership and team management skills.
- Excellent communication and interpersonal skills.
- Attention to detail and a commitment to excellence.
- Problem-solving and decision-making abilities.
- Proficiency in relevant software/tools.
- Fluency in English and Mandarin (both written and spoken) is essential.
Remote – Ability to travel to China several times annually.
To apply, please send your CV/resume and cover letter to firstname.lastname@example.org.