MC Local Quality Responsible
Illovo Johannesburg South Africa
Reports into : Head of Medical Affairs
Who we are
At Roche, more than 91 700 people in over 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups.
Our success is built on innovation, curiosity and diversity, and on seeing each other’s differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing and is seeking people who have the same goals for themselves.
Better outcomes for more patients faster
The Local Quality Responsible (LQR) is responsible for proactively ensuring that all GCP / GVP governed activities are delivered to the Roche standards of quality and efficiency in accordance with the appropriate Roche and industry requirements and regulations.
The LQR promotes quality and compliance excellence within the Affiliate by embedding quality principles throughout the organisation.
This is achieved through strong individual drive and close collaboration with other departments or key business representatives within or outside the Affiliate.
Your key activities will include :
Leads and manages the strategic and operational performance of the Quality Management System (QMS) at affiliate level, ensuring the successful delivery of the Global Quality Strategy, in alignment with annual Quality Objectives, whilst maintaining oversight and adherence to local regulatory requirements
Promotes a quality culture that ensures the highest standards of Quality and Medical Compliance and proactively monitors and oversees external regulatory changes affecting affiliate quality and compliance.
Drives the Affiliate Management Review Process ensuring that key quality or compliance issues are communicated effectively to senior management and appropriate actions are taken.
To be the QMS point-of-contact for the Affiliate with the Pharma Development Quality (PDQ) organisation.
Identifies and works in partnership with key affiliate stakeholders and Quality Country Cluster Lead (QCCL)to maintain quality standards
Drives and enables the overall continuous improvement process at local level and Leads the Risk Management Process for Medical Compliance at local level to proactively identify, manage and treat risks in order to support the business objectives of the local organization.
Implements global processes and drives local process improvement initiatives in collaboration with key stakeholders and QCCL
Oversees GCP / GVP service provider management process and the overall performance of vendors and be the point-of-contact for the Affiliate for GCP / GVP audits and inspections
Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies, and where a job title is not considered the final definition of who you are, but the starting point.
This challenging role requires the following Qualifications; experience and skills :
Bachelor degree in Science or Biology related field; advanced degree and / or certification preferred. Demonstrated knowledge of GCP / GVP regulatory requirements.
More than 5 years of experience in a Biopharmaceutical company or equivalent.
Quality Management experience desired and an understanding of Risk Management is a plus.
Experience of Health Authority Inspections and audits is desirable.
Understanding of Quality Principles related to ISO 9001.
Good stakeholder management and the ability to effectively collaborate across a global organization.
Ability to influence, act as a change agent, build consensus and manage conflict in challenging situations.
Ability to work as part of a team.
Strong verbal and written communication skills.
Excellent listening and decision making skills.
Well-organized, detail oriented professional and ability to prioritize and make decisions.
Highly self-motivated; able to lead initiatives with authority.
Fluency in English and local language.
Perform effectively and efficiently under high levels of pressure and tight deadlines whilst demonstrating acute attention to detail
Able to work within a team or independently
The next step is yours. To apply, please send your CV to Lungile at Lungile.zondi roche.com By 30th January 2020
Who we are At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups.
Our success is built on innovation, curiosity and diversity.
Roche is an equal opportunity employer.