Job Description
Hobson Prior is seeking a Quality Director for our Shannon sterile manufacturing facility. The role involves overseeing the quality assurance for GMP Operations and Compliance. The successful candidate will work closely with the Quality Leadership Team and the VP Quality to ensure alignment on decisions related to quality systems and processes.Please note that to be considered for this role you must have the right to work in this location.Key ResponsibilitiesManage and lead the QA department, including hiring, onboarding, coaching, performance management, and employee development.Provide technical QA expertise and leadership across GMP Operations.Develop and maintain monitoring systems for quality records.Ensure compliance with GMP, Data Integrity and Good Documentation Practice.Ensure proactive QA oversight on the shop floor.Oversee site-specific Risk Management processes.Prepare and host GMP regulatory inspections and partner audits.Promote a "Quality Mindset" and collaborate with global QA colleagues.Act as a deputy for other members of the Global Quality Leadership Team.RequirementsAbility to apply cGMPs in a GMP environment.Strong leadership skills with good collaboration, communication and problem-solving skills.Experience and knowledge of preparing for, hosting and follow up on regulatory inspections.Ability to establish and maintain effective working relationships with internal and external peers and stakeholders.Flexibility to meet changing needs and priorities of the business.Proven track record of developing and leading a high-performance team.Science-based degree e.g. BSc or MSc.Substantial Quality Assurance experience and 'hands-on' knowledge of GMP Operations and biopharmaceutical cell culture-based manufacturing techniques and requirements.Eligible to act as a 'Qualified Person' as defined in 2001/83/EC and 2001/82/EC (as amended), is preferable but not essential.For more information, please contact Frankie Cunningham.Apply nowIf you are interested in learning more or applying to this exciting opportunity then please click Apply and upload a copy of your CV. Alternatively for further details or to talk directly to a life sciences recruitment specialist directly please select Contact me at the top of this page. Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.By providing your details and submitting this form you confirm you have read and understood our privacy policy. We only share your personal details with our group companies at acaciumgroup.com/affiliates and those categories of third parties in our privacy policy at hobsonprior.com/privacy-policy. #J-18808-Ljbffr