Senior QC Lab Manager
Based in Manorhamilton Road, Sligo, we have a high containment facility where we have dedicated capabilities for potent active pharmaceutical ingredient and drug product manufacturing. We focus on innovative new technologies and with our high performing team; we develop and deliver products and processes We are always looking for talented people to join our team and, when we find them, we make it our business to treat them well. We are currently sourcing a High CalibreSnr QC Lab Managerto lead and coach our diverse, technicallab teamin Sligo. Reporting to the Quality Director, this position has been identified as akey talent development rolethat will be leveraged toidentify future leaders for local and international career opportunities. The successful candidate will be interfacing with theglobal quality groupand engaging with the local onsitesenior leadership teamto deliver our key strategic quality programmes. Supported by an Assistant Lab Manager, 3 Supervisors and 20+ highly skilled lab analysts, in this role, you willmanage API & Drug Product (DP)Laboratory Operations, Finished Goods, Raw Material/ In-Processand Laboratory Continuous Improvement/Compliance Operations. The Role. As the strategic & operational QC Lab Manager, provide key support and input to the Quality Director in ensuring the effective design and delivery of our strategic site quality projects, programs and associated long range plans. Have responsibility for the successful design and delivery of lab related programmes (including financial spend), engaging with and influencing key stakeholders both on. Lead and develop your high performing team ofSupervisors and Lab Analysts ensuring that the department has the appropriate talent and level of performance to meet business objectives. Foster culture of development and technical growth in the team; leveraging internal and external expertise to strengthen technical capabilities. Assure conformance to all government and corporate regulations. Responsible to develop, provide, defend, persuade Corporate/Plant practices with outside organizations. Routinely meet with regulators (FDA & EU) and customers to ensure no interruption in business due to compliance issues. Meet operations objectives within planned budgets, providinginput to Director for resources needed to construct budget, updates, and changes in financial plan. Establish and execute plans and commitments consistent to Development, Manufacturing, Customers and Business needs. Develop, negotiate, finalize timeline and cost estimates for projects and/or service contracts to support business operations and/or external customer’s needs. Propose, design, and execute projects related to the strategic needs of the business operations. Develop and consider alternative solutions and innovation to maximize business results, fostering a culture of new ideas and methodologies in the wider quality team. Leverage and share previous knowledge and experience of best in class quality and laboratory management systems. Partner with Quality Director and key internal stakeholders (Operations, Engineering, Supply Chain etc.) to advance the QC Lab support services capabilities, building on previous successes and lesson learnt to deliver improvements year on year. Participate / lead European lab improvement work streams in conjunction with colleagues across 4 European sites. Involvement in QC centre of excellence driving lab transformation initiatives across the companies’ network. Education & Experience. BSc degree in Science or equivalent and 10+ years of relevant experience OR MSc degree in Scienceand 8+ years of relevant experience ORPhD in Science or equivalent and 6+ years of relevant experience. Must be experienced and demonstrate high level of technical skill in technical lab operations and good understanding of related business. Related knowledge in Product Quality, Quality Control Lab Operation and Regulatory requirements is required. Prior experience of liaising with key regulatory bodies HPRA, FDA etc. Ability to work independently to meet operational goals and business needs. Ability to develop, design, executes and manage complex research programs. Ability to make operational and business decisions with minimum direction from immediate manager. Must have knowledge and skill in personnel management, and develop and managing budget. Ability to interact and establish positive interaction with internal/external customers. Shows broad understanding of the issues relevant to technical/science and business. To apply for this position please contact James Porter at Sigmar RecruitmentT: +353 91 455305E: firstname.lastname@example.org. All applications will be treated with the strictest of confidence. Sigmar will never forward your CV to a third party without prior consent. This job originally appeared on RecruitIreland.com.
105 days ago