MajResponsibilities：
The Quality Lead fChinese Mainland, Taiwan Hong Kong is a local, transversal role designed to:
o Act as the primary Quality contact fthe Affiliates in Chinese MainlTaiwan/Hong Kong. Drive, oversee manage the strategy framework fAffiliate Market Quality activities.
o Direct oversight to Affiliate quality personnel in Chinese MainlTaiwan/Hong Kong.
o Foster a culture of collaboration continuous improvement, emphasizing oversight to implementation compliance to UCB quality standards, policies, procedures, including compliance of cGxP regulation(s) imposed on controlled un-licensed medicinal products by national laws applicable regulatory authorities.
o Assist in the identification mitigation of GMP/GSP quality issues risks, highlight facilitate improvement opportunities solutions.
o Work with stakeholders (e.g., Affiliate Management, Market Quality, Global Quality, Supply Chain, Pharmacovigilance, Regulatory)ganizations to facilitate support fthe local Qualityganization ensure GxP operations deliverables are achieved in a timely manner.
o Support the Market Qualityganization, using UCB procedures guidelines, when identifying the right talents appropriate resources to achieve compliance, in line with UCBs vision values.
o Have overall accountability fthe Quality Responsible Person (QRP) function related to the China affiliate Drug Distribution License (GSP), ensuring effective oversight appropriate support to enable the designated QRP to exercise decision‑making authority over quality management in accordance with regulatory requirements. Where required, personally assume QRP responsibilities.
• Provide subject matter expertise represent department interests in meetings, projects, committees, improvement initiatives, as requested.
• Ensure compliance to applicable data integrity standards procedures.
• Take role as Taiwan Hong Kong Affiliates backup QA fbatch release complaint handling operation as needed.
• Act as Bio-safety responsible person to ensure required CIQ essential process & biosafety manual in place in use
• Act as Document controller fChinese affiliate in UCB eQMS
Requirements：
• 10+ years’ Quality experience within regulated pharmaceutical environment. Consumer Healthcare Pharma industry preferred.
• Strong knowledge of China MAH/GMP/GSP regulatory compliance, including experience with regulatory audits inspections.
• Bachelors Degree above;
• Licensed Pharmacist is expected
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