Roche
Healthcare
GPCGlobalComplianceAssuranceLead
Neural analysis suggests this role is
optimal for Mid candidates.
“GPC Global Compliance Assurance Lead at Roche. Skills: Global Compliance Assurance, Quality Management System, Audit Management, Regulatory Compliance, Team Leadership. Ensuring the GPC - Global Patient Care Organization has the highest quality standards and remains compliant at all times.. Leading and managing a team of GPC Compliance Assurance Leads, Compliance Assurance Specialists and PRI & Case Monitoring Specialists.”
What You'll Achieve.
Ensuring the GPC - Global Patient Care Organization has the highest quality standards and remains compliant at all times.; Ensuring Roche and partners' products and solutions meet global regulations, corporate standards, and expectations.; Continually improve the governance to meet evolving business and compliance needs.; Ensure the GPC Organization complies with regulatory requirements and corporate standards.; Ensuring the GPC Organization operates in an “inspection ready” manner.; Continuously maintain or optimize the overall compliance of GPC in the processing and documentation of customer concerns.; Ensure end-to-end compliance in the complaint handling process.; Driving team and individual performance.; Ensure the team delivers exceptional service while optimizing efficiency and effectiveness through continuous improvement.
Industry & Context.
Conceive corrective and preventive measures in case of findings; Collaborate in the design of training concepts to overcome identified knowledge gaps.; Solution-oriented
What They're Looking For.
Must Have
Minimum 4 years of experience in Quality Assurance, Compliance, or as an Auditor, preferably in a medical regulated environment., Profound knowledge of audit-related topics, legal regulations regarding data protection, and medical device guidelines., Fluent command of English
Nice to Have
Knowledge of Roche products, solutions, and systems is recommended., Any other language is a plus.
What You'll Do.
Ensuring the GPC - Global Patient Care Organization has the highest quality standards and remains compliant at all times.
Leading and managing a team of GPC Compliance Assurance Leads
Compliance Assurance Specialists and PRI & Case Monitoring Specialists.
Ensuring Roche and partners' products and solutions meet global regulations
and expectations by overseeing the monitoring
and timely reporting on the quality of interactions.
Maintaining an effective quality management system and governance
and continually improve the governance to meet evolving business and compliance needs.
Implementing a common quality framework across the GPC Hubs.
Analyzing results regularly
conceiving corrective and preventive measures in case of findings
and collaborating in the design of training concepts to overcome identified knowledge gaps.
Ensuring the GPC Organization complies with regulatory requirements and corporate standards.
Communicating significant quality
or regulatory issues and risks that may impact operations or regulatory compliance to local
regional or global management.
and conduct of audits
ensuring the GPC Organization operates in an “inspection ready” manner and that audit measures are strictly implemented.
Effectively lead and develop a team of GPC Compliance Assurance Leads
Specialists and PRI & Case Monitoring Specialists.
and continuously improve the Global Compliance Governance Model and related monitoring standards.
Accountable for the end-to-end audit process
including preparation work
managing the audit schedule
and ensuring the timely implementation of audit-related measures.
Implement and follow up on measures to continuously maintain or optimize the overall compliance of GPC in the processing and documentation of customer concerns.
Act as a contact person and expert with the different interfaces for all quality and compliance topics
proactively and in an advisory manner.
Main responsible for auditing and analyzing the compliance levels of the cases handled by GPC Advisors.
Close collaboration with global safety and post-market quality teams to ensure end-to-end compliance in the complaint handling process.
Foster a culture of excellence
and collaboration while driving team and individual performance.
Cultivate an inspiring team environment that promotes diversity
overcoming the challenges of a multi-location setup.
Ensure the team delivers exceptional service while optimizing efficiency and effectiveness through continuous improvement.
Drive the talent acquisition and hiring process
focusing on retaining top talent and maintaining a positive work environment.
Provide proactive feedback and coaching to team members
managing performance and contributing to succession planning and talent management.
How You'll Work.
Team & Collaboration
Close collaboration with global safety and post-market quality teams to ensure end-to-end compliance in the complaint handling process.; Foster a culture of excellence, inclusivity, and collaboration while driving team and individual performance.; Cultivate an inspiring team environment that promotes diversity, overcoming the challenges of a multi-location setup.; Works with autonomy and flexibility, always with a teamwork attitude.
Communication Scope
Excellent communication and presentation skills with the ability to deal with complex information.; Communicate significant quality, or regulatory issues and risks that may impact operations or regulatory compliance to local, regional or global management.
Process & Methodology
Managing the audit schedule, Ensuring the timely implementation of audit-related measures
Full Job Description
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 ## Mission As a GPC Global Compliance Assurance Lead, you will play a key role in ensuring the GPC - Global Patient Care Organization has the highest quality standards and remains compliant at all times. You will lead and manage a team of GPC Compliance Assurance Leads, Compliance Assurance Specialists and PRI & Case Monitoring Specialists. You will ensure Roche and partners' products and solutions meet global regulations, corporate standards, and expectations by overseeing the monitoring, reviewing, and timely reporting on the quality of interactions. You will help maintain an effective quality management system and governance, globally, and continually improve the governance to meet evolving business and compliance needs. Together with your team, you will implement a common quality framework across the GPC Hubs. You will analyze results regularly, conceive corrective and preventive measures in case of findings, and collaborate in the design of training concepts to overcome identified knowledge gaps. You will ensure the GPC Organization complies with regulatory requirements and corporate standards. You will communicate significant quality, or regulatory issues and risks that may impact operations or regulatory compliance to local, regional or global management. In addition, you will be accountable for the preparation, coordination, and conduct of audits, ensuring the GPC Organization operates in an “inspection ready” manner and that audit measures are strictly implemented. ## Key Accountabili
Applying for this GPC Global Compliance Assurance Lead role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Roche?
Real rants from real employees. Read before you apply.