Roche is seeking a Regulatory Affairs and Quality Assurance Manager to service Diagnostics, to be based in Nairobi, Kenya. The role will entail managing the regulatory and quality functions for Diagnostics in the export regions and to support the export distributors in country.
Among other duties, the role will entail:
Quality System Management
Conduct management reviews of the Quality Management System (QMS) by presenting and tracking performance against standards.
Implement quality systems in line with ISO and Divisional standards by reviewing and understanding divisional SOP’s, analyze their impact in the local environment and effecting relevant aspects.
Maintain the QMS by analyzing processes and identifying discrepancies against requirements and implement updates.
Address changes by evaluating the impact of change and identifying the correct processes, agreeing the action plans with the impacted parties and implementing the change using the appropriate SOPs and/or change processes.
Implement CAPA management by identifying the probable root cause, identifying the relevant corrective and/or preventative actions, executing the identified action and evaluating the effectiveness.
Conduct quality risk assessments by implementing the quality risk management SOPs, identifying risk areas and risk mitigation measures, advising on measures to be implemented, implementing risk mitigation measures and tracking effectiveness.
Manage data integrity by implementing relevant SOPs and documentation practices, reviewing data and documentation, identifying discrepancies and implementing corrective action daily
Support quality audits by performing self-inspections, performing external audits, identifying audit queries, drafting audit reports, engaging with the relevant parties to implement corrective action and following up on agreed actions in line with the audit plan.
Support the recalls process by liaising with the distributor to facilitate recall, contacting customers and reconciling the returned goods.
Perform the annual product quality review by implementing the SOPs in line with the plan and drafting the summary annually.
Maintain knowledge on PQS by participating in training, reading and understanding SOPs and attending other learning platforms.
Case Management and Governance
Manage cases received by analyzing and identifying discrepancies and taking corrective action in line with Case Investigation Resolutions.
Complete case reviews on a monthly basis by assessing sampled cases against the required standards and support case owners to resolve.
Create awareness on case management by facilitating training based the relevant standards.
Act as deputy LSO in the territory
Regulatory Affairs
Support the registration of products by compiling, submitting and following-through on all Marketing authorisations with relevant authorities in line with in country guidelines.
Maintain authorized products by submission of variations and renewals and supplementary marketing authorisations.
Maintain licensing requirements by collating records of new products and updating regulators on the new products.
Support registration of electronic products by submitting and following through of the application to the relevant authority.
Establish relationships with regulatory authorities, with local industry medical device and IVD through attendance of meetings and working with industry peers to lobby Ministry of Health on matters of a regulatory nature.
Engage product managers on laws and regulation that would affect business process by providing the changes.
Post Market Surveillance
Report all adverse events with Regulatory authorities and facilitate recalls by investigating the recall, preparing and submitting communications, answering queries and providing additional information where applicable.
Support product notifications (safety board notifications and quality notifications) by identifying customers affected by the notifications, communicating the notification details, facilitating that corrective action is implemented and providing feedback to the Safety Board.
Supply Chain Management
Support the release of commercial product batches that are affected by deviations to the local applicable market by reviewing compliance with the local regulations, Roche guidelines and the marketing authorization and required KPI’s, identifying anomalies and providing recommendations and feedback.
Support the returns process by implementing the SOP, evaluating returned goods and accompanying information and deciding on the disposition as required.
Support the supply chain performance by monitoring the 3PL quality KPIs on a monthly basis and as required.
Contract Management
Assist with oversight of warehouse and distribution providers by monitoring compliance with the required standards and in line with the quality agreement, implementing the SOPs, identifying areas of concern and addressing these with the service providers until resolved.
Monitor and support the implementation of local Roche SOP’s, analytical methods and working instructions at the contract laboratory by drafting required documentation, monitoring implementation, addressing any areas of non-conformance or non-compliance and implementing corrective action.
Stakeholder Engagement
Liaise with internal and external stakeholders by providing input on quality standards and procedures, liaising with them on procedures and building skills in the quality standards and procedure requirements.
You, as an ideal candidate, will have the following skills, experience and education:
Required Qualification: NQF 7 in Sciences related degree or equivalent.
Required Experience: 3 - 5 years’ experience in a pharmaceutical or medical device environment in a Regulatory and Quality Assurance Management role. Demonstrated experience in maintaining and upholding rules and SOPs is required as well as knowledge of regulatory frameworks and regulations.
