Medical Compliance Lead

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Principle Roles & Responsibilities / Accountabilities (Major functions of the position)

1. Lead Medical Compliance strategy development

Build up and implement medical compliance strategy efficiently to optimize all compliance activities with timely risk assessment and risk minimization/management plan implementation in Medical.

2. Lead Implementation of QMS in the Affiliate

• Lead the implementation of the global Roche QMS at Affiliate level to meet regulatory requirements.

• Contribute to the continuous improvement of the global QMS by providing Affiliate insights.

• Drive the implementation in the Affiliate of the global and local Quality strategies, objectives and initiatives, as applicable.

• Drive and enable the overall CAPA management process at local level (self-identified deviations, audits and inspections findings), and proactively identify related trends and risks, to lead continuous improvement.

• Implement the global PD training process for QMS activities, and ensure that an aligned local training strategy is in place.

• Drive the local implementation of QMS procedural document lifecycle management.

• Proactively monitor and oversee external regulatory changes affecting affiliate QMS in alliance with process owners and ensure that the local regulatory requirements are implemented.

• Partner with the Affiliate COREMAP representative to implement the records management requirements for QMS in accordance with the Roche Global Records Management Directive.

• Ensure that the global Service Provider management and oversight process is implemented in the Affiliate.

3. Lead Affiliate Medical Compliance Oversight

• Lead the process to measure the overall Affiliate Medical Compliance status and take actions as needed.

• Lead the Affiliate Management Review (MRs) and Local Medical Compliance Office (LMCO) ensuring that key outputs are understood by senior management and appropriate decisions and actions are taken where necessary.

• Ensure key insights on QMS health are escalated to Global functions as per the Medical Compliance governance model.

4. Lead Affiliate Risk & Opportunity Management for Medical Compliance

• Lead the Risk & Opportunity management and escalation process at local level to proactively identify, manage, mitigate and escalate Medical Compliance risks.

• Contribute to the delivery of quality solutions through collaboration with business partners and other functions to support effective risk minimization and identify opportunities to create a competitive advantage for the organization.

5. Lead Affiliate Quality Monitoring

• Identify the need for establishing an affiliate quality monitoring strategy in collaboration with relevant local and global stakeholders, in the areas of QMS and Medical Compliance.

• As applicable, design, lead and/or execute the Affiliate Quality Monitoring strategy in collaboration with local and global stakeholders in order to proactively identify and mitigate potential risks.

6. Support Audits and Inspections impacting Affiliates

• Support the PDQ Quality Assurance global strategy by providing affiliate insights.

• Coordinate and/or support, in collaboration with PDQ, the preparation, execution and CAPA response to the Audit and Inspection findings impacting QMS and GCP/GVP regulatory compliance.

• Lead Inspection Readiness activities/initiatives for GCP/GVP inspections according to needs.

7. Quality Responsibilities in Affiliate Specific Business Areas

• Undertake other quality responsibilities that may arise in emerging Quality areas (e.g. Healthcare Solutions, RWE, medical devices) as per business needs, work packages and/or as defined in local/global procedures, systems, regulations and requirements.

8. Training Compliance and Optimization

• Assess and determine the technical training and development needs of Medical staff (GxP and Medical HCP Compliance focus).

• Lead the team to design, develop, deliver and/or organize learning events (e.g. Quality workshop, conference) by leveraging experts/resources from local and global organization or liaising with external trainers.

• Advance Medical staff awareness of procedures and policies changes to regulation or company requirements.

9. Partnership with the local/global department

(1) Local Requirements and Operations

• Keep abreast of local regulations pertaining to medical activities that are sponsored or supported by Roche China

• Provide interpretation on local regulations and ensure processes are effectively described in terms that will satisfy local requirements.

(2) Quality Business Partner

• Lead the team to provide Medical compliance support by answering questions and providing advice on ICH-GCP/GVP/HCP Compliance, Global SOPs, and local regulations.

• Lead the team to Provide Medical compliance expert consultancy on training of required SOPs/regulatory to applicable Medical staffs.

(3) Build up cross-functional compliance communication and collaboration to ensure an effective and seamless interaction with other functions within and outside Medical Division.

Qualifications and Experience

Education/Qualifications

• At least with a master degree of medicine / pharmacy /Public health.

• Relevant working experience:

• At least 8 years experiences including experience in clinical research, pharmacovigilance or HCP compliance with at least 3 years medical compliance or quality assurance, such as GxP or Healthcare compliance

• Experience in working with a cross-functional team and international network, preferably in a GxP function

• Experience/involvement in audits (and Health Authority inspections) is preferred

• Medical Affairs experience is preferred.

Job Required Competencies

• In-depth knowledge of ICH-GCP/GVP/HCP Compliance, SOPs and local regulatory requirements

• Strong business acumen with demonstrated expertise in QMS, Medical Compliance, Service Provider Oversight, CAPA and Risk Management, process simplification.

• VACC Leadership Skills

• Strong partnering and networking capabilities, ability to influence.

• Excellent stakeholder (internal and external) engagement and effective collaboration skills

• Understanding of Data Analytics and ability to derive Qualitative insights

• Familiar with the Agile methodology/tools including innovative and creative thinking

• Strong verbal and written communication skills

• Highly self-motivated and able to lead initiatives

• Ability to translate strategic objectives into operational goals to accelerate results through strong focus on outcome based planning

• Fluency in English and local language

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, weve become one of the worlds leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche China consists of the full value chain of Pharmaceuticals and Diagnostics fields, from early research, clinical development, manufacturing to commercialization. With more than 7,000 employees, Roche China is now working to develop itself into Roches third global strategic center after Basel and San Francisco, and making sustained efforts to fulfill its long-term commitment to China, so as to meet Chinese patients unmet needs.

Roche is an Equal Opportunity Employer.

Information :

• Company : Roche
• Position : Medical Compliance Lead
• Location : 上海市
• Country : CN

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