Quality lead Chinese Mainland & Taiwan & HongKong

Make your mark for patients

We are looking for a Quality Lead to join us to lead Chinese Mainland Taiwan and Hong Kong quality team based in our Shanghai office.

About the role

• This position Act as the primary Quality contact for the Affiliates in China and Taiwan/Hong Kong. Drive oversee and manage the strategy and framework for Affiliate Market Quality activities.
• Direct oversight to Affiliate quality personnel in Chinese mainland and Taiwan/Hong Kong.

• Foster a culture of collaboration and continuous improvement emphasizing oversight to implementation and compliance to UCB quality standards policies procedures including compliance of cGxP regulation(s) imposed on controlled or un-licensed medicinal products by national laws or applicable regulatory authorities.
• Assist in the identification and mitigation of GMP/GSP quality issues and risks highlight or facilitate improvement opportunities or solutions.
• Work with stakeholders (e.g. Affiliate Management Market Quality Global Quality Supply Chain Pharmacovigilance Regulatory) organizations to facilitate support for the local Quality organization and ensure GxP operations deliverables are achieved in a timely manner.
• Support the Market Quality organization using UCB procedures and guidelines when identifying the right talents and appropriate resources to achieve compliance in line with UCBs vision and values.
• Have overall accountability for the Quality Responsible Person (QRP) function related to the China affiliate Drug Distribution License (GSP) ensuring effective oversight and appropriate support to enable the designated QRP to exercise decisionmaking authority over quality management in accordance with regulatory requirements. Where required personally assume QRP responsibilities.

What youll do

1. Apply for and maintain the China affiliate Drug Distribution License (GSP) through appropriate oversight and governance. When required personally assume and perform the role and responsibilities of the Quality Responsible Person (QRP) in accordance with applicable GSP regulations.
2. Ensure that the required QMS for the Domestic Responsible Entity (MAH deputy) is established and effectively implemented in accordance with local laws and regulations including the preparation of required documents such as the China Annual Report.
3. Ensure oversight and execution of the local Quality Management System:
4. Provide subject matter expertise and represent department interests in meetings projects committees and improvement initiatives as requested.
5. Ensure compliance to applicable data integrity standards and procedures.
6. Take role as Taiwan and Hong Kong Affiliates backup QA for batch release and complaint handling operation as needed.
7. Act as Bio-safety responsible person to ensure required CIQ essential process & biosafety manual in place and in use
8. Act as Document controller for Chinese affiliate in UCB eQMS

Interested For this role were looking for the following education experience and skills

• Bachelors degree and above; Pharmacist License is preferred
• 10 years Quality experience within regulated pharmaceutical environment. Consumer Healthcare or Pharma industry preferred.
• Strong knowledge of China MAH/GMP/GSP regulatory compliance including experience with regulatory audits and inspections.
• Should be a self-motivated team player that is able to work autonomously exercise good judgement using a quality mindset ability to handle complex/difficult situations foster an attitude of collaboration and ability to act as a role model for others in driving the company vision incorporating strong ethical and patient focused principles.
• Experience operating in a multi-cultural and locational environment. Must be able to effectively interact and communicate (verbally and written) with internal and external stakeholders. Ability to communicate both verbally and in writing using the local country language and English is preferred.
• Experience in people management including oversight to day-to-day responsibilities performance monitoring and providing guidance on career growth and development.
• Experience in developing effective solutions that foster process and business improvement.
• Experience in Pharmaceutical manufacturing site is an advantage
• Experience in project management quality auditing risk management and data analytics is preferred.
• Experience using key computerized systems (e.g. SAP Veeva Microsoft applications).
• Ability to travel when required.
• Fluent Chinese and workinglevel English proficiency required to effectively execute job responsibilities.

Are you ready to go beyond to create value and make your mark for patients If this sounds like you then we would love to hear from you!

About us
UCB is a global biopharmaceutical company focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe inspired by patients and driven by science.

Why work with us
At UCB we dont just complete tasks we create value. We arent afraid to push forward collaborate and innovate to make our mark for patients. We have a caring supportive culture where everyone feels included respected and has equal opportunities to do their best work. We go beyond to create value for our patients and always with a human focus whether thats on our patients our employees or our planet. Working for us you will discover a place where you can grow and have the freedom to carve your own career path to achieve your full potential.

At UCB weve embraced a hybrid-first approach to work bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description or precluded by the nature of the position roles are hybrid with 40% of your time spent in the office.

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.