QA Lead, Biologics

Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.

Die Position

Principle Roles & Responsibilities / Accountabilities主要职责/责任

Quality and Technical Guidance

• Play the role of quality compliance oversight, provide immediate support and guidance during the project phase and RCPT routine GMP operation, including but not limited

• End-to-End (E2E) GMP Onsite Oversight: Provide quality oversight for E2E GMP operations, including aseptic filling & packaging, facilities & utilities, warehouse & logistics, and QC laboratories, ensuring a high level of compliance in all onsite operations.

• Data Integrity (DI) Governance: Serve as the company's Data Integrity compliance lead; supervise the compliance of data throughout its entire life cycle and drive the deep implementation of ALCOA+ principles across both production shop floors and laboratories.

• Contamination Control Strategy (CCS) Implementation: Responsible for onsite compliance audits under the CCS framework; supervise sterility assurance, airflow patterns, cleaning & disinfection, and bioburden control to ensure that contamination prevention measures remain under control during both the project phase and routine operations.

• Develop, review and maintain comprehensive quality documentation (manuals, SOPs), ensuring they comply with GMP/GDP/Roche requirements, are up-to-date, and accessible.

• 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

Wer wir sind

Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.

Gemeinsam können wir eine gesündere Zukunft gestalten.

Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.