Site Quality Head

MSD

Dunboyne

Job Description. We have an amazing new opportunity for a  Site Quality Head who will provide strategic leadership and governance at our new state of the art single use biotechnology facility, BioNX, in Dunboyne, Ireland.  The role is responsible for leading the Site Quality team’s development programs for our portfolio, specifically in terms of assuring the reliable availability, quality and regulatory compliance of biologics supplies produced at the facility.  What you will do: Ensure reliability of biologics products manufactured for clinical trials and launch via operational management for the biologics disposition, with the associated potential for high impact to the development and launch portfolio.  Preferably, the Director will also be eligible to be a QP on the site license to support certification and release. Sponsor the development and execution of quality strategies, improvement initiatives in line with business drivers and objectives. Provision of in-depth technical / quality expertise re; development of identification of trends and/or potential compliance gaps and proactively leading the resolution of long-standing or significant issues affecting quality and efficiency. Inspire Diversity and Inclusion – building working effective working relationship within a cross-functional team across different cultures and backgrounds. Lead the Quality team providing ongoing coaching and support to all team members, including the identification and development of key talent and skills within the team. Develop an effective, focused, and strong team by understanding: their abilities, unique contribution and broadening their skill set to be agile and prepared for any future business requirements.  Drive the team’s performance so that every individual sees their individual contribution and how it impacts the pipeline and patient. Provide your team with the tools and development opportunities (including educational assistance, job rotation, cross-functional training, Six Sigma) to make them successful. What skills you will need: Bachelor’s degree, or higher, in a Life Science discipline. A minimum of 10 years of relevant working knowledge ideally related to manufacturing of biologic medicinal products. Eligible to be listed as a QP on the site license. Experience interacting with regulatory officials. As a company, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. We are committed to flexible working where possible, and our aim is to balance your needs with the needs of the business. This could be a hybrid way of working with some time on site and some remotely or flexibility around the hours you work each day. Of course, in some parts of the business, certain roles do require a full on-site presence, whilst others can be performed entirely remotely. Please speak to us during your application process to discuss further. So, if you are ready to: Invent solutions to meet unmet healthcare needs, please apply today. Current Employees apply HERE. Current Contingent Workers apply HERE. Search Firm Representatives Please Read Carefully  Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.  .

991 days ago