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 PositionGlobal GMP Compliance Expert (APAC)
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.
That’s what makes us Roche.
The Audits & Compliance group is responsible for continuous Inspection Readiness Program & Response Management Process, Pharma Technical (PT) Global Audit Program Management and Execution, Global GMP Compliance Expert Competency and Knowledge Management, Network Oversight and Preparation of Product Compliance for Launch Readiness and Remediation Program Management as well as providing Quality and Compliance oversight to PT network QMS documents
The Opportunity
Be a part of Audit & Compliance team to:
Conduct independent Quality & Compliance audits of Internal/ External sites, affiliates, suppliers, and service providers; communicate compliance deficiencies, risks, and assess the adequacy of responses (CAPA plans) within Asia Pacific and other global locations.
Prepare, execute, and follow-up on audits (routine, qualification, for-cause, due-diligence, GMP assessments). Maintain broad compliance understanding and continually pursue learning in new technical areas. Besides that, engage in flow to work opportunities to support projects and Inspection management activities.
Based on knowledge & qualification (training) ensure delivery of Audits & Compliance outputs: QMS document oversight, Audits, Inspection Support, and other compliance-related work packages. Collaborate with stakeholders to identify network inspection and audit risks and develop strategies to mitigate those risks.
Support the Audit & Compliance team to develop and maintain the goals, objectives, and strategic partnerships for inspection management, audits, and other key compliance topics at Roche sites/ affiliates, Contract Organisations, Partners, and Suppliers.
Provide expertise in the interpretation and communication of emerging regulatory trends, new regulations, and regulatory intelligence impacting GMP compliance . Contribute to optimize our Operating model, and continually identify organizational efficiencies.
Partner with Audits & Compliance leaders and team members to identify and implement compliance-focused continuous improvement efforts to accelerate decision-making and drive efficiencies. Support capability development within Audits & Compliance to ensure appropriate flow to work.
Partner with other PT/PT Quality functions to enable network knowledge, interpretation of GMP requirements and Health Authorities expectations. Act as a strategic partner with PT/PT Quality to develop and improve Quality Management Systems
Act as an advisor to internal project teams by providing compliance knowledge of regulatory requirements, industry standards, company strategy, and GMP expertise across the PT network.
Who you are
You should hold a BA or BSc degree or equivalent in life sciences, Pharmacy or related scientific discipline with at least 10 years experience in a regulated industry, such as the pharma/bio-pharmaceutical or medical device industry with preferred 5 years of working in GMP Audits or Inspection
You should have a strong understanding of Quality/Compliance regulations, including pharmaceutical Good Manufacturing Practices (cGMP) & Good Storage & Distribution Practices (GSDP)
You should demonstrate ability to coach and influence teams without direct authority (reporting structure) and have experience in various platforms of manufacturing technologies and product life-cycle is desirable.
As this position is part of a global organization, domestic and international business travel of about 40% is required depending upon the business needs.
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.
