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 PositionQuality and Technical Guidance
Support mobilisation of new sites from a quality, compliance perspective.
Develop and roll out resources in order to ensure full compliance with Roche’s quality management system (QMS)
Oversee Technical Change Control process. Act as the Chair of Local Change Review Board to ensure the effectiveness of the process.
Oversee Risk Management and provide relevant tools and expertise.
Effective governance and internal communication / escalation within Roche PT organization.
Present quality compliance status information, data analysis, metrics and general overviews to client management or internal customers
Provide strategic direction and manage execution of regulatory inspections, internal and external audits and paper-based inspections.
Provide strategic direction and oversight for the establishment and execution of the site self-inspection program.
Execute various processes (e.g. QMS / documentation control, change control) in compliance to relevant standards.
Produce monthly reports to regional management teams highlighting successes and hot spots
Develop and deliver training programs on quality assurance topics, ensure relevant employees are adequately trained on quality standards and procedures, and evaluate the effectiveness of training programs to enhance knowledge and compliance.
Education/Qualifications
The candidate should have at least a Degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, or a related discipline.
In-depth and current knowledge of all relevant GxP and Quality System requirements (US, EU) for pharmaceutical and biotech, manufacturing and related activities.
Experience on managing regulatory inspections with Global Health Authorities and of interacting with representing the company to Health Authorities, their agents, or related entities.
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 the pharmaceutical or biotechnology in quality assurance, GMP compliance, operations or validation, ideally in a multinational company.
Aseptic Filling experience is required and experience in 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.
Experience with tools like SAP, Veeva, Orca, and demonstrating strong stakeholder management, independent problem-solving, critical thinking abilities, and agile skills with flexibility to adapt to changes.
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.
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
- Minimum 7 years experience in quality assurance, GMP compliance, operations or validation in the pharmaceutical or biotech industry
- Degree in pharmaceutical sciences, life sciences, biology, biotechnology, chemistry, chemical engineering, or a related discipline
- In-depth knowledge of GxP and quality system requirements (US, EU)
- Experience managing regulatory inspections with Global Health Authorities
- Aseptic filling experience
- Experience with tools like SAP, Veeva, Orca
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.
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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.
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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.
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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).
