ABOUT YOU

We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients’ lives.

QUALIFICATIONS:

• Minimum Bachelor’s Degree in Chemistry, Pharmacy, Life licenses or equivalent
• Eligibility to fulfil the requirements of HPRA Good Distribution practice in respect of a Responsible Person/Designated Person

EXPERIENCE & COMPETENCES

• Minimum 5 years’ experience of working in a similar role within a pharmaceutical company.
• Able to travel within Europe, or globally for Quality and/or Commercial and/or Technical project activities
• Capable of working to deadlines & remain calm under pressure
• Proven ability to organize and prioritize multiple tasks
• Ability to work on own initiative & juggle priorities
• Ability to work effectively as part of a team

KNOWLEDGE & SKILLS:

• Proven managerial experience and ability to develop staff
• Excellent communication skills, both oral and written, to include senior management in third party suppliers
• Well organised with logical & methodical approach to work
• Sound problem solving skills
• Good organisation & time management skills

ABOUT THE ROLE

• Leadership and management of the GDP Compliance team and consultant RPs
• To act as a named operational Responsible Person and Designated Person under the site wholesale distribution authorisation(s) and Active substance registration(s)
• To execute Responsible Person duties as per the EU Guidelines on Good Distribution Practice (2013/C 343/01), (2015/C95/01) and relevant local guidelines
• Maintain effective and compliant Quality System

KEY RESPONSIBILITIES:

• Leadership and mentoring of the GDP Compliance and Contract RP teams
• Responsible for Commercial Quality strategy and execution including WDA strategy, resourcing, and maintenance
• Establish and maintain systems, processes, and resources in accordance with business and GxP requirements for all areas of responsibility
• Establish quality objectives and KPIs (including reporting) for areas of responsibility
• Oversee and ensure readiness for inspections by Health Authorities associated with WDAs and ASR
• Lead and support interactions with Health Authorities
• Lead major quality related incident resolution and provide guidance and solutions to technical and quality related issues
• To oversee systems and approve related documents (as necessary) for Deviations, Complaints, CAPA, Audits, Self inspection, Change Control, Customer Returns, Stock transfer request forms, Customer and Supplier Bona fide checks and Management Review
• Fulfilment of the requirement of GDP guidelines and Routine Duties of a Responsible Person/ Responsible Person for Import/ Deputy Responsible Person (as appropriate) as laid down in EU GDP guidelines for Medicinal products for human use, EU GDP guidelines for Active substance and relevant local regulatory requirements
• Maintain an open team culture focused on continuous improvement and talent development
• Responsible for identifying own training and development needs and ensuring Continued Professional Development
• Actively participate as a member of the Quality Leadership team
• Budgetary responsibility for relevant areas and ensure adherence
• Other activities as may be required, at the discretion of management