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
Qualifications
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
