Assoc Director - Compliance
CAREERWISE RECRUITMENT
CORK
Our multinational Pharma & Biotech client has an immediate requirement for an Associate Director of Compliance ( Compliance coach) .The Associate Director of Compliance is responsible for maintaining all aspects of compliance within the site Vaccines IPT team, including GMP, EHS, Technical and compliance. Please contact Diarmuid Buckley for further details. ROLE: * Interprets internal and external regulatory and compliance developments and communicates action to Department and site as appropriate. * Act as coach for all members of department in compliance. Works closely with teams to ensure that day to day activities are compliant and aligned with procedures. * Accountable for Permanent Inspection Readiness (PIR) in the department, including development and maintenance of a proactive compliance risk register for the IPT to ensure PIR. * Gemba's areas frequently ensuring that areas are always audit ready. * Assist in formulating corrective plans where required and putting a process in place confirming that actions are addressed. * Accountable for all maintenance & adherence to standards owned within the department e.g. Quality Management Systems, Engineering Standards, Validation Standards. * Is the front room lead for all corporate and external body audits (GMP, EHS, Trade and Statutory Inspections. * Participate and comply with the Divisional Quality Management System (QMS) requirements, including ownership, as relevant. * Owner for the departmental compliance calendar ensuring that all compliance activities for the department are tracked, highlighted and action plans are in place for. * Direct Management responsibility for Compliance Team. Accountable for delivering on compliance projects. REQUIREMENTS: * Degree in (Science/Engineering). Masters would be an advantage. * 7 years' experience in pharmaceutical industry. * 3 years' experience in operational leadership. * Demonstrated technical knowledge and experience in compliance (GMP, Eng, Technical. * Experience in regulatory Prior Approval Inspections (PAI) would be an advantage. * Green Belt or equivalent LSS experience would be an advantage. Please call Diarmuid Buckley today for further information on 021- 4355432 or email: dbuckley@careerwise.ie. 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.
1628 days ago