A career at our company is an ongoing journey of discovery: our around 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
Job Title: Senior Quality Consultant
Preferred location: Shanghai or Beijing
The candidate will need be familiar with NMPA/EU/US FDA GMP, international industrial best practices regulations of biopharma industry e.g. monoclonal antibodies, novel therapy and gene therapy, vaccines. The candidate will have ability to lead consultancy project and conduct GMP related training and internal audit, to qualify manufacturer to ensure full compliance with GMP and all related regulatory requirements.
Key Job Responsibilities:
•Project work in all project phases as per business needs;
•Solve tasks independently, to the highest degree of complexity;
•Ensure interfaces to and coordination with other disciplines.
•Ensure changes to the scope of work are brought to the attention of the project management.
•Generate, maintain and improve Quality Management System (QMS) including policy/standard, SOP and working instruction, etc.
•Introduces, interprets, reviews and ensures the full implementation of regulations and guidance documents from international and national regulatory authorities. Assesses compliance risk and recommends corrective action.
•Readiness preparation for GMP, GSP, ISO9001 and other quality system inspections, and other quality system inspections by executing readiness plan.
•Plans and leads internal audit to identify gaps and provide recommendation for solutions.
•Establishes and manages quality management systems, e.g. Deviation, CAPA and Change Control process;
•Monitor the progress to ensures on time closure and submission of execution summary to operation committee.
•Audit external suppliers, contract manufacturers and third part service vendor.
•Draft and negotiate the Quality Agreement based on newest regulations if necessary.
•Monitor customer quality system, implement quality audit and follow up CAPA
Who you are:
Education and Languages:
•Bachelor in life sciences or related science/engineering background with a strong emphasis in biologics.
•Fluent in Chinese & English (written) is required.
Professional Skills and Experiences:
•Minimum of 8 years of relevant quality experience in biopharmaceutical companies or consultancy companies. 2+ years of practical QMS experience is preferred.
•Knowledgeable of NMPA pharmaceutical regulations and regulatory landscape of other important country/regions (eg. China, Japan, South Korea, EU, US)
•Proven knowledge of cGMP, FDA, EMA, ISO 9001 standards, international industrial best practice and guidance, regulatory and compliance requirements, aseptic process.
•Knowledge/experience for regulations regarding complex biologics (i.e., monoclonal antibodies, novel therapy and gene therapy).
•Experience working in a global, matrix environment.
•Be familiar with biopharma manufacturing process, post approval change evaluation , and new drug registration process, etc.
Personal Skills and Competencies:
•Strong organizational and time management skills.
•Good project management skills.
•Able and willing to travel frequently（Could work and relocate on project site for more than 3 months based on project needs）
•Ability to train and educate others.
•Effective management by influence.
•Ability to work in multi-cultural teams.
•Good listening skills with the ability to analyze and respond to given situations quickly and effectively.
•Excellent interpersonal, presentation, listening and communication skills that will develop long term internal and external relationships at all levels.
•Ability to indirectly influence other organizations and cultures.
•Proficient in MS Office Software (Word, Excel, PowerPoint, Project).
Function Area: Regulatory & Quality
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com