GCP Director

Company Profile：
We are a global, clinical stage biopharmaceutical company developing innovative therapeutics in the fields of immuno-oncology and inflammatory diseases.
Our discovery and development programs are driven by unmet medical and patient needs and strong science supported by our two patented transgenic mouse platforms for generating fully human monoclonal antibodies. We focus on developing an innovative pipeline of Next-Gen therapeutics through our internal R&D programs, collaborations with co-discovery and co-development partners and select acquisitions.
With operations in the US, the Netherlands, and China, we also license our core platform technology to other companies and academic institutions globally.

Responsibilities:
Help Head of Quality set up and maintain the QMS to ensure GCP processes / activities in compliance with applicable current ICH guidelines and country / regional regulations, in accordance with the company strategies.
• Work with Medicine team to support and ensure the quality on the processes / activities of
o Document management
o Personnel qualification & Training
o The management of GCP Quality Risks / Issues
o GCP vendor management and strategy
o GCP audit plan, implantation and trend analysis
o GCP inspection readiness
o Any GCP projects and requirements for continuous improvement.
Internal and External Relationships.
• Interface with personnel at all levels in HBM relevant functions.
• Interact with Regulatory Inspection Agencies WW, stay abreast of evolving regulations and influence future regualtions.

Requirements:
Education:
• B.Sc. in a scientific discipline plus 5 years experience in an R&D based pharmaceutical company.
• M.Sc. Quality Management or equivalent qualification, highly desireable, but not essential.

Experience & Knowledge:
• At least 5-year previous experience in GCP Quality is required, knowledge of ISO 9000 quality systems / ICH Q9 (QRM) / Q10 (PQS) is desirable.
• Current knowledge of legislative and regulatory requirements as they effect pharmaceutical research and development is essential.
Core competencies:
• Good interpersonal skills, including but not limited to leadership, assertiveness, negotiation in difficult situations, handling multi-tasks are essential.
• A broad understanding of the drug research and development process, especially biological product and a detailed, current knowledge of all applicable regulations governing the conduct of R&D pharma as well as a current knowledge of GxP are essestial.
• English language skill is mandatory. Awareness of cultural difference would be beneficial in promoting and facilitating good working relationships.

If you are interested in applying for this position, please contact us at HBM.HR@harbourbiomed.com