QA Head

Proclinical is advertising a vacancy with a leading biotechnology company that is developing a portfolio of novel bi-specific antibodies in oncology and immune-oncology. The company is seeking a QA Head to join their team in Shanghai. This is an exciting opportunity for an experienced incumbent to join an up-and-coming organisation that has successfully raised $25 MM with a consortium of international investors.

Job Responsibilities:

• Directing a quality team (6-12 staff members) to ensure the facility quality system can meet the international compliance for biotherapeutic clinical production.
• Drafting quality assurance policies and procedures for GMP scale-up production.
• Establishing quality management systems (e.g. documents, materials, production) within the company's regional research/scale-up facility.
• Interpreting and implementing quality assurance standards.
• Leading and preparing internal/external audits and other quality inspection activities.
• Monitoring the performance of quality control operation and risk management activities in daily basis.
• Setting up regular staff training programs and schedules to meet the requirement of GMP compliance.
• Overseeing the facility management as the key member of the regional leadership team, including policy making activities.
• Proactively supporting IND and NDA regulatory submission.

Skills and Requirements:

• At least a Bachelors' Degree in a life science field, though a PhD is preferred.
• At least 8 years of experience in quality control or assurance for biologics quality inspections, auditing, and GMP/GLP testing.
• Certifications are an advantage, including in Quality Auditing, Quality Engineering, and Quality Improvement Association.
• An in-depth knowledge of FDA, EMA, and CFDA regulatory requirements for biologics submission.
• Fluency in English, in both a written and verbal capacity.
• Capable of working independently, analysing, working with attention to detail, process and prioritise sensitive complex information, and solving problems.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency in MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Lily Zhao at +86 21 51694106 or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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