(Associate) Manager, QS & Compliance, Biologics
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Job Location:
Monthly Salary:
Posted on:
19-10-2025
Vacancies:
1 Vacancy
Job Summary
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
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 Roches quality management system (QMS)
Oversee Technical Change Control process. Act as the Chair of Local Change Review Board toensure 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 externalaudits 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 100000 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.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Required Experience:
Manager
Key Skills
- Jsf
- Access
- Civil Engineering
- Cost Estimation
- Computing
- Corporate Recruitment
About Company
F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel.
