QA Lead 生物制药QA负责人
Roche · Shanghai
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The Position
Principle Roles & Responsibilities / Accountabilities主要职责/责任
Product Release & Batch Documentation Management
Batch Record Review: Lead the comprehensive review and approval of all Batch Production Records (BPR) and Batch Control Records (BCR) to ensure completeness, accuracy, and strict adherence to cGMP standards.
Release Decision & Certification: Facilitate the efficient and timely release of products by verifying all testing results against specifications and issuing Certificates of Analysis (CoA) for final batch disposition.
Aseptic Oversight: Oversee the local batch release process specifically for aseptic filling and packaging operations, ensuring that sterility assurance and environmental monitoring data support the release.
Materials Management & Supplier Quality
Material Disposition: Manage the quality oversight of raw materials, consumables, and primary packaging materials, ensuring they are sampled, tested, and released on-time to support production schedules.
Perform thorough risk assessments to identify potential quality risks, develop and implement risk mitigation strategies
Supplier Lifecycle Management: Lead the quality evaluation and qualification of material suppliers based on risk-based quality criteria and international regulatory requirements.
Service Provider & Third-Party Oversight
- External Service Governance: Manage the quality oversight of third-party service providers and external laboratories, ensuring that outsourced testing and GMP-related services (e.g., calibration, validation) meet internal quality standards.
- Quality Agreements: Drive the establishment and maintenance of Quality Agreements with service providers and third-party labs to clearly define compliance responsibilities.
- Audit & Inspection Readiness: Collaborate and lead during internal/external audits and Health Authority (HA) inspections, representing the quality status of supplier and service provider management systems.
Annual Product Quality Review (APQR) & Quality Trend Analysis
- APQR Compilation & Coordination: Lead the end-to-end preparation, coordination, and compilation of the Annual Product Quality Review (APQR) to evaluate the consistency of existing manufacturing processes and the appropriateness of current specifications.
- Data Synthesis & Statistical Analysis: Systematically review and analyze critical data, including batch records, out-of-specification (OOS) results, deviations, changes, and stability data, utilizing statistical tools to identify any adverse trends.
- Compliance Assessment: Evaluate the effectiveness of corrective and preventive actions (CAPAs) and previous year’s recommendations to ensure continuous improvement in product quality and process robustness.
- Regulatory Reporting: Ensure the timely completion and archival of APQR reports in compliance with global regulatory requirements (e.g., NMPA, FDA, EMA), and present key findings during Quality Management Reviews or health authority inspections.
- Responsible for ensuring that product quality issues are correctly investigated, and that appropriate corrective and preventative actions are implemented. Review deviation/exception/ investigation reports.
- Support and represent QA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.
- Maintain project timelines associated with initiatives to support the evolving business.
- Participate in tech transfer, collaboration with other functions to ensure the success of new product manufacturing.
- Support the compliance, regulatory and training activities as required,
- Support the continuous improvement and oversight of QA Compliance programs and identifies and implements new technologies to improve the compliance and efficiency of QA operations.
- Other related duties as assigned.
Qualification and Experience 能力与经验
Education/Qualifications
- The candidate should have at least a Degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, or a related discipline.
- Certification and trainings such as auditor training will be advantageous.
Leadership Competencies
- Models Integrity
- Focus on value and customer
- Align for success
- Deliver results
- Learn for the future
Job Required Competencies
- A minimum experience of 7 years in pharmaceutical or biotechnology in quality assurance, GMP compliance, operations or validation, ideally in a multinational company.
- Aseptic Filling experience is required and experience in the new DP facility project is expected.
- FDA/EU cGMP know-how and a thorough understanding of ICH guidelines, together with exposure to the international regulatory network.
- Able to logically solve problems in order to find timely solutions.
- An ability to interact and communicate with all types of personalities in an effective and diplomatic manner
- Good decision-making capability
- Experienced in new facility startup readiness and operation ramp up
- Fluent communications skills in English and the ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders
Who we are
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.