Roche Diagnostics in Midrand, South Africa is seeking a Compliance Officer to take on the key role in promoting high standards of integrity and to ensure compliance in line with global guidelines as well as local laws and regulations through adequate procedures and process controls. Support is required in fostering a climate and culture of compliance through training, monitoring and pro-actively addressing compliance issues. The successful candidate would be required to act as an independent function to give assurance to senior management that business activities are executed within an adequate control framework
- Support the local CO to foster a mindset/culture of compliance.
- Create training material and provide compliance training to all functions. Ensures all employees are well trained and training records are maintained. Puts adequate local trainings plans in place and ensures timely completion of global trainings and puts communication plans in place.
- Develop, deliver and maintain communication to ensure local organizations’ compliance awareness and knowledge.
- Ensure compliance with global standards/ guidelines (e.g. Code of Conduct, Directives, SOPs) as well as local laws and ensure effective as well as efficient processes and tools are in place to manage compliance; drive initiatives for continuous improvement; ensure monthly and detailed review of key business transactions such as T&E, Marketing Activities, Sponsorships, etc. Perform risk based ad-hoc reviews (deep dives) where deemed necessary and work out action plans to address recurring issues; ensure RDSA employees understand global and local compliance standards.
- Provide transparency through adequate review mechanisms and reporting and provide as well guidance to the business functions and answer their questions regarding the defined compliance standards.
- Define and maintain local policies/SOPs according to the regulatory environment and global/regional directives and policies.
- Build a thorough business understanding to provide adequate support to the business. Develop an internal network to stay informed about planned/executed activities.
- Local processes and systems enable effective and efficient compliance management; local activities are in line with global, regional and local laws, directives and guidelines. HCO and CCO actions implemented in line with regional/global guidance and timelines. Periodic updates are provided to CO which are tailored to the local needs in reflect local risk exposure.
- Timely identification of local trends and adequate actions to ensure alignment. Non-adherence is detected timeously and adequate actions/sanctioning are initiated.
- Active role in the local compliance network to shape/influence major policy changes.
- Implement HCO action plans and actions based on the global CCO in line with regional/global timelines.
Regulatory, Quality and Complaints Management
- Ensure adequate business process controls and risk management. Drive actions to close gaps in local policies and procedures.
- Take ownership of internal policies, procedures and SOPs to ensure they enforce compliance and ensure adequate control. Perform a yearly review of operational risks and define an audit plan. Additionally perform ad-hoc audits where deemed necessary during the year. Ensure adequate
- tracking of actions plans resulting from internal audits to ensure timely implementation.
- Drive identification for and execution of continuous improvement strategies. Ensure team compliance adherence to all relevant Roche guidelines and policies. Remain up to date with business, industry, product, SOPs knowledge regarding functional requirements within Roche local or global structures (complete IDP objectives for period).