Director Regulatory Compliance

Job Description

A Director Regulatory Compliance (Process Excellence) is required by CareerWise Recruitment for our North Dublin based client. The Director, Regulatory Compliance will build and lead a newly established Global Regulatory Affairs (GRA) Compliance function, with responsibility for defining, embedding and continuously improving compliance across GRA. The role will partner closely with cross-functional stakeholders to monitor adherence to regulatory processes, lead audit and inspection readiness and learning, and own the development and evolution of the GRA Quality Management System (QMS). HYBRID 3-Days-per week in-office & 2 WFH!!!!

Role of this position

Compliance

• Leadership and oversight on GRA compliance related topics, inspection & audit outcomes and trending.
• Provision and as needed escalation of GRA compliance related topics to Senior Leaders
• Oversight of authorities’ inspections and internal audits of GRA, incl. outcome & findings monitoring; tracking and monitoring of QE/CAPA related activities for GRA
• Strong support in compiling and collecting information being presented to auditors
• Close connection to and collaboration with cross-functional teams related to compliance in and outside GRA
  
  

Quality Management System (QMS)

• Develop and Evolve the GRA Quality Management Systems (QMS), incl. GRA process hierarchy, procedure design, review and approval process, regular risk assessments, maintenance of a GRA Quality Plan, oversight on Management review of systems and a high-level definition of GRA roles and responsibilities
  
  

Regulatory Process Adherence Oversight

• Oversight of GRA controlled Documents, review and sometimes approval of new GRA procedures
• Monitoring process adherence in GRA incl. cross-functional involvement and strategic partnership on all aspects related to regulatory process adherence oversight
• Oversight on procedures owned outside GRA but where regulatory is listed in the responsibility section and/or being trained on.
• Close collaboration with the extended leadership team on all compliance and process adherence related topics, review and input into curricula and support for evaluation of training needs throughout GRA.
  
  

Job Requirements

• Engaged leader with demonstrable experience of effective delivery in a complex matrix and multi-national environment and experienced in audit and inspection conduct in a European Market
• Knowledgeable and engaged in all matters related to compliance in the pharmaceutical industry
• Collaborative team player with excellent interpersonal and strategic influencing and cross-functional working skills.
• Proven ability to partner successfully with other Regulatory functions, Quality, Safety, Medical and other internal stakeholders to achieve objectives.
  
  

Please call Tom Devaney for further information on 091-758771 or email: [email protected]

CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.