Local Quality Responsible
Roche
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The Opportunity
Roche Pharma in Midrand is seeking a Local Quality Responsible (LQR) to join their team.
You as a LQR are a strategic quality partner of the Country Medical Director (CMD) and Affiliate business. You are responsible for implementing the Affiliate Quality Management System (QMS) and ensuring local Medical Compliance-related activities are delivered. LQRs provide support to the CMD in maintaining the affiliate License to Operate (LTO) and are accountable for medical compliance reporting and inspection readiness, in alignment with local regulations and global standards.
Key Challenges
Quality System Administration
Lead the implementation of the global Roche QMS at the affiliate level to meet regulatory requirements.
Drive the implementation of the global and local Quality strategies, objectives, and initiatives as applicable.
Drive and enable the overall CAPA management process at the local level (self-identified deviations, audits, and inspection findings), and proactively identify related trends and risks, to lead continuous improvement.
Drive and implement the local 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, as per the Regulatory Intelligence Process.
Partner with the Affiliate COREMAP representative to implement the records management requirements for QMS in accordance with the Roche Global Records Management Directive.
Medical Compliance and Risk Management
1. Lead Affiliate Medical Compliance Oversight as per Affiliate Medical Compliance Oversight Process
Lead the process to measure the overall Affiliate Medical Compliance status and take necessary actions.
Define and oversee local metrics. In collaboration with functional SMEs, as required, ensure adequate metrics are in place to assure compliance.
Lead the Affiliate Management Review (MRs) and Affiliate Medical Compliance Office (AMCO,) ensuring that key outputs are understood by senior management and appropriate decisions and actions are taken where necessary.
Contribute to the continuous improvement of the global QMS by providing Affiliate insights through SIRIUS.
Ensure key insights on QMS health are escalated to Global functions as per the Medical Compliance governance model.
Ensure that the global Service Provider management and oversight process is implemented in the Affiliate by defining adequate KPIs and metrics to allow compliance oversight and/or by dedicated quality monitoring/quality check activities to evaluate compliance.
2. 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.
3. Lead Affiliate Quality Monitoring
Based on the identified risks, establish a need for an affiliate quality monitoring strategy in collaboration with relevant local and global stakeholders, focusing on QMS and Medical Compliance.
As applicable, design, lead, and/or execute the Affiliate Quality Monitoring strategy in collaboration with local and global stakeholders to proactively identify and mitigate potential risks.
4. Support Audits and Inspections impacting Affiliates
Support the PDQ Quality Assurance global strategy by providing affiliate insights.
Lead Inspection Readiness activities/initiatives for GCP/GVP inspections as needed.
Lead/Support Local Health Authority Inspections as required
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.
Other Responsibilities in Affiliate-Specific Business Areas
Undertake other responsibilities as delegated by CMD (e.g., Local Regulation Compliance and Monitoring, Digital Health solutions development (MD) enablement, RWE/D, MAP) as per business needs, work packages, and/or as defined in local/global procedures, systems, regulations, and requirements.
Who You Are as an Ideal Candidate
Qualification/Knowledge and Experiences
A bachelor's Degree in Life Science or equivalent is preferred
More than 5 years of experience in a biopharmaceutical company or equivalent
Strong business acumen with demonstrated expertise in QMS, Medical Compliance, Service Provider Oversight, CAPA, and Risk Management, process simplification
Demonstrated applied knowledge of ICH GCP, GVP, and other relevant regulations and requirements, at a global and local level
Understanding the Quality Principles of ISO standards (e.g, ISO 9001 Quality Management System & ISO 31000 Risk Management and ISO 13485 Medical Devices)
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
Skills, Mindsets & Behaviors
VACC Leadership Skills
Strong partnering and networking capabilities, ability to influence without authority
Excellent stakeholder (internal and external) engagement and practical collaboration skills)
Strategic mindset, System thinking, enterprise mindset
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 a strong focus on outcome-based planning
Fluency in English and the local language
Note that a full job description is available at request.
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.
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