About Us:

Opella is the self-care challenger with the purest and third-largest portfolio in the Over The Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally. Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting.

At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.

As a globally certified B Corp company, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com.

Mission & Tasks 使命与任务

Opella’s ambition is to revolutionize self-care. Quality is everyone’s responsibility in our “Health in Your Hands” mission, making self-care as simple as it should be.

欧彼乐致力于在 “自我健康管理” 领域引领变革。在欧彼乐 “健康在握” 的使命中，质量是每个人的职责所在，让自我健康管理变得触手可得。

The Quality Manager plays a critical role in maintaining and enhancing Opella China's Quality Management System. This position is responsible for ensuring compliance with GxP regulations, company standards, and industry’s best practices across all operations. The role involves executing quality processes, conducting inspections, managing documentation, and supporting continuous improvement initiatives to deliver trusted healthcare solutions to patients and consumers.

Quality System Management质量体系管理

• Quality and Regulatory Conformity 药品经营质量管理规范法规合规
• Audit and Inspection审计与检查
• Cross-functional Collaboration 跨职能协作

Scope of Responsibility 职责范围

Management Responsibilities:

1. Quality System Management 质量体系管理：
1. Quality System Implementation 质量体系实施
2. Self-inspection (Internal Assessment, IA) 内部审核
3. Deviation & CAPA Management偏差与CAPA管理
4. Additional Responsibilities 其他职责

Quality and Regulatory Conformity 药品经营质量管理规范法规合规：

1. QMS Establishment & Maintenance for GSP（MAH Downstream）
2. Quality Risk Management质量风险管理
3. Supplier & Customer Qualification Management 供应商与客户资质审核
4. Product Disposition (Support) 产品处置
5. Returns, rejected, or recalled products 退货、不合格品及召回管理
6. Third Party Management外部合作方管理
7. Product Complaint Management 产品投诉管理
8. Drug Traceability Management 药品追溯管理

Audit and Inspection 审计与检查：

Participate in the preparation and implementation of internal and external audits and inspections.

Cross-functional Collaboration 跨部门协作：

Support and coordinate post-marketing quality activities related to the MAH

Latitude of Action 行动自由度：

Monitor and enforce quality standards compliance, promptly reporting any non-conformances to the Country Quality Head with root cause analysis and recommended corrective actions.

Investigate and resolve quality events in accordance with company procedures, escalating urgent cases, significant events, or adverse trends to the Country Quality Head with comprehensive impact assessments.

Proactively monitor regulatory developments and intelligence, analyze potential impacts on operations, and provide consolidated reports with actionable recommendations to the Country Quality Head.

Review and update Quality Agreements to define appropriate latitude of action for third parties, ensuring they can perform routine quality activities independently while maintaining oversight for critical decisions affecting product quality and compliance.

Role Impact 岗位影响:

The Quality Manager contributes to Opella China's Quality Management System by supporting the implementation and maintenance of comprehensive quality processes across the entire product lifecycle, ensuring all GxP activities consistently comply with regulatory requirements and company standards.

Scope 岗位范围:

This role collaborates with Opella China staff across multiple functions and may engage with external service providers as required to support quality management initiatives.

Required Experience 任职要求

• Bachelor's degree or above in Pharmaceutical Sciences, Chemistry, Bioengineering, Life Sciences, or other relevant scientific disciplines (Must).
• 5 years plus working experience (include at least 1 year in GSP) in pharmaceutical industry, preferably in MNCs.
• Licensed pharmacist qualification (Preferred)

Required Skills 技能要求

• Technical Competencies 技术能力
• Strong analytical thinking and problem-solving capabilities.
• Hands-on troubleshooting skills with practical application experience.
• Proficiency in risk assessment and root cause analysis methodologies.
• Internal and External Audit experience.
• Personal Attributes 个人素质
• Proactive mindset with a “can-do” attitude and good sense of responsibility.
• Ability to work effectively under pressure and in complex matrix environments.
• Strong adaptability and resilience in dynamic situations.

Language Requirements 语言要求

Fluent in English (reading and writing); strong communication skills preferred.