Associate Manager, QA Biologics 生物制药QA副经理

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
Quality and Technical Guidance
Play the role of quality oversight, provide immediate support and guidance during the project phase and RCPT routine GMP operation, including but not limited imported DS material release, master manufacturing record establishment, aseptic filling & package operation oversight, quality evaluation on any issues or queries that may arise during product handling.
Develop, review and maintain comprehensive quality documentation (manuals, SOPs), ensuring they comply with GMP/GDP/Roche requirements, are up-to-date, and accessible.
Evaluate new suppliers and service providers based on quality criteria and regulatory requirements, and collaborate during external/internal audits and health authority inspections.
Perform thorough risk assessments to identify potential quality risks, develop and implement risk mitigation strategies
Responsible for ensuring that product quality issues are correctly investigated, and that appropriate corrective and preventative actions are implemented. Review deviation/exception/ investigation reports,
Assure the efficient, timely, batch record review and CGMP compliant materials and products release.
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.