Job Description
The role: PE Global is currently recruiting for QC Shared Services Senior Manager on behalf of a leading biologics company based in Dublin North. This is an initial 12 month contract role. Position Summary: QC Shared Services Senior Manager - QC Projects. Reporting to the Quality Control Shared Services Associate Director, this position has responsibility for the learning & development management, QC Trending Management and execution of Continuous Improvement projects. Responsibilities: Leadership of QC Shared Projects team to support manufacture, testing and release of Drug Substance and Sterile Drug Product Responsible for the Site Trending Program for Quality Control Responsible for delivering the QC Project portfolio in line with the overall QC Strategic Objectives Responsible for delivering continuous improvement initiatives to facilitate ongoing cost saving and performance excellence Develop a technical training structure and associated program to facilitate ongoing and consistent learning & development across the QC organization in line with the QC Network Strategy Ensures audit readiness, both internal and external Ensures the QC Projects Team operates in compliance with company policies and directives, evolving Health Authority regulations and expectations. Builds and fosters strong relationships within the biologics quality and global quality network to drive compliance, strengthen quality systems and support company objectives. Keeps abreast of current corporate and industry requirements and compliance trends as they pertain to QC Responsible for coaching, developing staff and completion of performance appraisal reviews. Inspires transformative thinking and motivates employees to deliver benchmark performance. Support QC planning and scheduling activities as required. Prioritise safety in every aspect of the role Lead by example in exemplifying safety behaviours Education & Experience: The successful candidate must possess a Bachelor/Masters in Science or Science related discipline and have a minimum of 6 years experience in the Pharmaceutical Industry. Deep and demonstrated understanding and experience of the principles of GMP / GDP An accomplished people manager with the ability to motivate and develop departmental staff through effective feedback and coaching The candidate will have proven success working well in a team environment, as well as proven leadership skills to manage a team of professionals through changing business needs. Experience with interacting with regulatory agencies. Knowledge of US and EMA GMP regulations and guidance. Demonstrated leadership, interpersonal, communication, and motivation skills. Demonstrated understanding of test methods and instrumentation associated with the testing of biopharmaceutical processes including chemistry and microbiological testing. Planning and organizing skills are required to plan, execute and manage resources against timelines and project commitments; must be able to adjust to changing priorities and a dynamic work environment. The candidate will have demonstrated strong leadership and people / project management abilities as well as proven decision-making ability. Additionally, the successful candidate must be able to interact with a broad range of disciplines and exert positive influence within internal matrix teams across a variety of functions. Interested candidates should submit an updated CV. Please click the link below to apply, call Kellie on or alternatively send an up to date CV to ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland*** Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. Skills: quality control testing drug substance HPLC