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 PositionRoles & Responsibilities
Engineering Project Support and Operation Readiness:
Equipment and System Support:
Act as the QC equipment SME to contribute to project design, construction, and qualification. This includes participating in equipment selection, URS (User Requirement Specification) review, and IOPQ (Installation, Operation, and Performance Qualification) to ensure successful project delivery.
Support the establishment and development of the QC operation system in alignment with Roche standards. This involves creating a maintenance management system, and an automation strategy(eg. LIMS, Empower, SAP) and implementation to support robust operational readiness.
Lead the setup of sample and material management processes for QC operations and ensure all necessary processes, documentation (SOPs), and tracking systems are in place for the management of samples and testing materials from day one.
Lead the setup of sample and material management processes for QC operations and ensure all necessary processes, documentation (SOPs), and tracking systems are in place for the management of samples and testing materials from day one.
Support all QC activities during regulatory inspections and audits and participate in the response to regulatory and global quality audits.
As the experienced SME, proactive drive the continuous improvement in Lab support team by leading the taskforce to identify and implement new technologies to improve the compliance and efficiency in routine QC operations.
Routine Operation:
Safety Management:
Be the QC SHE SPOC and to maintain strict adherence to Roche's SHE (Safety, Health, Environment) standards and all regulatory guidelines.
Actively promote a safety-first culture within the team and report any incidents or deviations promptly.
Equipment and Method Lifecycle Management:
Be responsible for the operation and maintenance of relevant equipment with Roche‘s QMS standards and regulatory guidelines.
Develop and execute preventive and corrective maintenance programs to maximize equipment availability and optimize life-cycle costs.
Ensure all computerized systems are maintained in a validated state throughout their operational life.
Drive operational excellence through the implementation of digital solutions and continuous improvement initiatives.
Support the integration of new technologies and digital tools to enhance lab efficiency and data management.
Support the lifecycle management of analytical methods, including implementation, transfer, and periodic review, to ensure compliance with cGMP and Roche standards.
Data Integrity Assurance:
Ensure the QC data flow generated by lab equipment and maintenance activities are compliance to DI requirements.
Ensure all data is maintained in accordance with cGMP and company standards for data integrity.
Sample and Material Management:
Ensure the proper receipt, logging, storage, and traceability of all samples according to established SOPs.
Conduct Stability，retention sample management with compliance to cGMP.
QC Compliance Assurance:
Ensure audit readiness by complying with effective standards, regulatory/statutory, and cGMP requirements
Provide technical support on all lab-related topics during internal and external audits.
Qualification and Experience
Education/Qualifications
Bachelor’s Degree (Life Sciences, Pharmaceutical Sciences and Analytical Sciences is preferred) and above
Strong knowledge of QC operation and maintenance with experience in aseptic processes preferred
Leadership Competencies
Models Integrity
Focus on value and customer
Align for success
Deliver results
Learn for the future
Job Required Competencies
3 or more years of QC experience, MNC Bio-pharma preferred
Sound knowledge of quality control procedures and legal standards.
Sound knowledge of mathematics, data analysis, and statistical methods.
Experience in strategic project of QC design, commissioning & qualification
Experience in QC routine operation and QC systems(eg.LIMS, Empower)
Experience in operation and maintenance of QC operational excellence (eg.Lean and 6 Sigma).
Have the potential to think strategically and translate strategies into actionable plans, understands and apply agile ways of working
Fluent communications skills in English and the ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders across the network.
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.
Skills Required
- Bachelor's Degree in Life Sciences or related field
- 3 or more years of QC experience
- Knowledge of QC operation and maintenance
- Experience in strategic project of QC design, commissioning & qualification
- Fluent communication skills in English
Roche Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Roche and has not been reviewed or approved by Roche.
-
Retirement Support — U.S. materials describe a 401(k) with both matching and an additional company contribution, supported by formal plan documents and true‑up features. This structure is positioned as a standout element of the total package, particularly at Genentech.
-
Leave & Time Off Breadth — Time‑off provisions include substantial vacation, a year‑end shutdown, and a paid six‑week sabbatical after six years. These elements indicate a recharge‑oriented approach within the U.S. offering.
-
Healthcare Strength — Company materials emphasize comprehensive medical, dental, vision, and mental‑health resources alongside well‑being programs. Benefits pages consistently highlight breadth across core health coverage elements.
Roche Insights
What We Do
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI).
