Quality Systems and Compliance Lead

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

Quality 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.

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.