Ad/ Director - Inspection Readiness
CareerWise Recruitment
Limerick
A Director / Associate Director of Inspection Readiness is required by CareerWise Recruitment for our Mid West based Biotech client. Please contact Diarmuid Buckley for full details. THE ROLE: * Provide support during regulatory inspections and internal audits. * Work to ensure that all identified content is organized, current and readily accessible in the event of an inspection or audit purposes. * Work with department leaders to build an inspection readiness capability across the organisation. * Benchmark leading practices and recommend improvements to make site inspection-ready at all times. * Build and implement tools to improve site inspection readiness. * Identify trends in recent regulatory inspections and translate this to recommendations to enhance readiness. * Work closely with other regulatory compliance team to close gaps and improve inspection readiness capabilities. * Liaison with regulatory bodies, partners and key suppliers on audit, regulatory, and quality related matters and to provide guidance and advice to partners, suppliers and internal associates on regulatory and quality matters. * Ensure marketed products are in compliance with global regulatory and guidance requirements primarily US and secondarily EU. * Define and implement quality standards, systems, and metrics for maintaining regulatory compliance for clinical and commercial operations. * Interfaces with customer/partner quality organizations. REQUIREMENTS: * BA/BS degree in chemical engineering/chemistry/life sciences; process engineering or validation. * 10 + years of relevant experience in a biotech or pharmaceutical environment. 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. Please call Diarmuid Buckley today for further information on 021- 4355432 or email: dbuckley@careerwise.ie.
1038 days ago