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Primary Purpose of Job (Job Summary)
Serve as the Quality Point of Contact (PoC) for designated CMO(s) and participate as a key member of CMO governance teams to enable site selection and implementation (including due diligence activities), product transfer, on-going quality supply from commercial CMO sites, and/or decommissioning.
Provide Quality and Compliance oversight for Roche products manufactured at Contract Manufacturing Organizations (CMOs) to ensure compliance with Drug Administration Law of the People's Republic of China and relevant regulations and Quality Agreement. Lead and promote the continual improvement of the Quality Management System in CMO sites.
Your Opportunities:
Principle Roles & Responsibilities / Accountabilities
1. Selection & Implementation Phase
Oversee all required Quality activities for technical product transfer & launch during Implement phase at CMOs including GMP commissioning, oversight of validation activities and GMP document approval.
Oversee all required Quality activities for method transfer and test/specification readiness during Implement phase at Roche site including oversight of validation activities, release/stability testing and GMP document approval.
Oversee material supplier selection, qualification, and approval throughout the project lifecycle, and ensure the Approved Supplier List is provided to the CMO for GxP execution.
Develop, negotiate and maintain Quality Agreements with CMO and ensure compliance with agreements.
Provide as needed support during regulatory inspections and cGMP compliance audits, collaborating with CMOs to ensure on time closure of associated CAPAs when requested.
Coordinate and facilitate CMC submissions, variations and dossier updates as applicable with Roche Technical Regulatory and CMO.
By communication of the specific quality topics
2. Commercialization Phase
Manage all required activities to support Make Assess Release (MAR) of commercial product including approval of process related documentation as agreed in Quality Agreement, investigations handling, assessment of change controls, and monitor and report CMO quality performance.
Oversee complex investigations in partnership with CMO, and management of the Quality Review Board process and application of effective Root Cause Analysis (RCA).
Perform quality complaint investigations with CMOs and ensure investigation action plans and final investigation summaries are accurate, include appropriate corrective actions, and follow company standards.
Develop/maintain quality risk management plans; utilize risk management tools to identify and mitigate CMO quality and compliance risks, ensuring CMO sites are in a state of continuous inspection readiness.
Ensure that CMO provides Annual Product Quality Reviews, and other GMP documents in a timely manner and right first time.
Define and deploy the schedule for Quality Oversight in CMO sites.
Support the job of maintaining the business needed licenses.
Lead and promote the continual improvement of quality management system in CMO site
3. Complete other tasks assigned by senior leaders
Who you are:
Qualification and Experience
1. Education/Qualifications
Bachelor Degree (4 years education of Pharmacy, Pharmaceutical, bioengineering, Chemistry or equivalent education level)
Graduate or higher-level Degree is preferred.
2. Leadership
May mentor and/or coach colleagues their knowledge / skill within and outside the organization.
Contributes by participating in large/global cross-functional or cross-chapter squads where it may take a leading role.
Navigates in complex situations by applying a diverse skillset.
3. Job Required Competencies
Experience (may vary depending on site size/scope)
7 or more years’ work experience in the biopharmaceutical or related industry
5 or more years’ experience in a commercially licensed GMP facility
Preferred experience with contract manufacturing organizations
Knowledge/Skills/Competencies
Expert knowledge of Quality System and QA principles, practices and standards for the pharmaceutical industry.
Expert knowledge of cGMP relevant to the pharmaceutical industry
Strong knowledge of pharmaceutical, biotechnology or medical device related product operations including local and international quality regulations.
Project management skills
Demonstrate excellent verbal and written communication skills in English
Focus on value and customer
Learn for the future
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.