Antibody-Drug-Conjugates (ADCs) - VP QA/QC
Anti-tumor Antibody-Drug-Conjugates (ADCs) platform
VP role to build up QA/QC Process and Procedures
About Our Client
Company was established in 2014 with aim to build-up a world class bio-conjugation technology platform in China. Their product focus is on developing next generation anti-tumor ADCs with be-st-in class potential. Backed by key China PE funds they currently operate 20 people production line with pilot scale production of 100 Litres.
- Oversees all facets of a company's Quality Control and Quality Assurance, ensuring that the product is manufactured to an exacting standard consistently.
- Responsible for managing all Quality related activities for Suzhou site
- Define strategic direction and Quality objectives for the business including Quality Assurance, Quality Control, GxP Compliance, GxP Training, Validation, and Document Control functions
- Assurance that the appropriate suite of Standard Operating Procedures are in place and optimally maintained to support the critical drug development activities as well as our vendor relationships with our external CRO or CMOs.
- Coordination and execution of periodic Quality Management Reviews and trend analysis of all aspects of GXP operations.
- Support current Phase I and Phase Clinical process and prepare for new Clinical submission and further Phases across global market
- Take responsibility of Quality team - Manage and develop a group of Quality professionals who are collectively responsible for carrying out the QA mission and responsibilities
The Successful Applicant
- Advanced degree in a scientific or operational discipline relevant to the life sciences and/or operations areas
- 10+ years of quality assurance experience in biopharma or relevant organisations
- Proven background in building QA/QC process in a start-up organisation will be a plus. Solution-based approach with strong audit skills will be preferred
- Multidiscipline expertise and experience in a CMC QA role as well as familiarity with Clinical and Non-Clinical requirements and responsibilities.
- Excellent working knowledge, understanding and experience with the practical implementation of FDA and CFDA regulations and guidelines in GLP, GCP and GXP environments.
- Highly capable and knowledgeable in the concepts, practices and leadership of process-based management and team governance
- Exceptional oral and written communication skills to all employment levels, Board of Directors and external partners, suppliers and industry organisations
- Demonstrated ability to analyse, extrapolate data, hypothesise, plan, communicate and implement in a highly collaborative and engaged environment.
- Exceptional interpersonal skills including the ability to influence behaviours and negotiate and resolve challenges with poise, tact and diplomacy
What's on Offer
You will be offer VP for Quality role and report directly to the CEO of the company.