Quality Systems and Regulatory Compliance Specialist - MISSA
Johnsons and Johnsons,
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Quality Systems and Regulatory Compliance Specialist - MISSA-Description Johnson and Johnson Caring for the world one person at a time inspires and unites the people of Johnson and Johnson We embrace research and science -

bringing innovative ideas products and services to advance the health and well-being of people Employees of the Johnson and Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day throughout the world We have more than 275 operating companies in more than 60 countries employing nearly 128 000 people Our worldwide headquarters is in New Brunswick New Jersey USA Our culture is interconnected by the shared values of Our Credo It s a culture that celebrates diversity and diverse perspectives It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities Johnson and Johnson Middle east covers 3 sectors Consumer Medical Devices and Diagnostics and Pharma Generally covers Middle East North Africa and Pakistan region 37 countries 300 employees across MENAP with 37 Nationalities In order to streamline the complexity of the current MISSA Maghreb Iran Sub -

Saharan Africa business model and consolidate the management and order-to-cash processes within one location J J MISSA operations is moving from Kirkton Campus in Scotland and the Shared Customer Service center in Paris to J J Middle East office in Dubai Main Responsibilities Responsible for development and implementation of quality systems based on business regulatory and customer requirements in accordance to J J requirements Also provides training and consultation to various parts of the business and resolves procedural breakdowns To manage vigilance activities recall stop shipment complaints To represent MISSA in J J Quality Councils Establish J J MISSA QM framework set QRC targets ensure effective flow down and monitor performance Establish corrective and preventative actions to mitigate potential or actual non compliance risk Ensure compliance to all applicable quality standards and regulatory requirements Drive simplification and standardization of QS in MISSA in line with J J MD D strategies and initiatives Ensure timely and consistent escalation of events Connect with QRC leaders of the direct companies and other MD D groups Bus to align on strategy for audits in the region Develop lead and maintain a comprehensive audit readiness programme for MISSA to ensure internal and external compliance Conducts internal audits to determine compliance with quality management system standards as well as regulatory and customer requirements Drive accountability for compliance to foster a compliance driven culture Represent MISSA in EMEA Market Quality Leadership Council Conducts distributor qualification activities Close collaboration with business and stakeholders Build relationships with all levels of management within MISSA Qualifications Education and qualifications Degree level educated ideally in a quality or relevant business degree 2-

4 years of experience of quality systems and auditing Experience from a multi-national or regional company in Healthcare Pharmaceutical Consumer Fluency in English Primary Location Europe Middle East Africa-

United Arab Emirates-DubaiOrganization Johnson and Johnson Middle East FZ-LLC 8608 Job Function Quality Systems

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