Compliance Manager Global Health provider
Our client a Global Health provider works closely with pharmaceutical companies, healthcare providers and governmental and non-governmental organisations to improve access to healthcare in emerging economies through innovative, sustainable solutions. They are a consulting company specialised in the design and implementation of patient- focused market access strategies for healthcare companies. With 20 years of focused experience in access to healthcare in emerging economies, they bring a number of unique advantages to its clients and partners:
• Evidence-based proprietary methodologies and tools to help formulate, manage and evaluate strategies and programs to deliver optimal results.
• Global network of contacts in government institutions, public and private hospitals and clinics and patient organizations allowing for significant local intervention capabilities.
• Multi-disciplinary teams of access specialists across Africa, Asia, Latin America, U.S., Europe and the Middle East specialized in health policy, economics and financing, laboratory and clinical management, drug logistics, research, communications and human resources management. They haves experience designing and implementing access to healthcare solutions in 100+ countries and more than 9 million people have received tests or treatments through managed programs.
The Compliance Manager will be based in Dublin and is responsible for the QMS standard.
Duties and Responsibilities
A variety of responsibilities will be requested inclusive of the following:
· Work with Senior team to develop compliance and QA priority areas
· Prepare QA manual control and supervision of all amendments and revisions
· Control and distribution of all quality documentation
· Monitor all quality related activities in Programs
· Develop QMS activities with Program staff including set up, planning and implementation of Projects
· Work with Program staff to ensure SOPP’s, company policies, procedures, and work instructions are documented according to ISO and other relevant standards
· Assist in the preparation of proposals and DDQ’s
· Roll out periodic training ensuring staff have received appropriate training and are assessed as competent in QMS
· Ensure training is according to ISO and other relevant standards
· Investigate escalated incident(s) assigned in a timely fashion
· Review deviation investigations and actions as required including corrective action / continuous improvement implementation
· Working with Program staff identify and action relevant legislative requirements
· Maintain standards through internal audit activities and schedule
· Assist as required during the external audit and risk assessment schedule
· Additional projects as required
Management of the ISO certification ensuring that this and other third-party accreditations are obtained and maintained
· Results orientation
· Technical Skills
· Project management
· Problem solving
· Customer focus
We are seeking candidates from a Pharmaceutical / Health background with proven experience in compliance /QA in a Health or pharmaceutical related field.
Educational Background and Experience
· Bachelor’s degree in a Compliance / Quality discipline with concentration in a Health-related field
· 5 years’ experience in related industry, including proven experience in ISO standards
Cv’s to firstname.lastname@example.org