QC Chem Lead - Associate Director
Posted on Apr 24, 2021 by Elevate Direct
QC CHEM LEAD - ASSOCIATE DIRECTOR
Location: Dunboyne, Co. Meath, Ireland
The QC Chem laboratories will have full capabilities and responsibilities for all product release testing, stability testing and appropriate in-process & utilities/cleaning testing. The scope spans incoming raw material, component, chemistry and bioassay. The QC Chem lab will consist of the latest analytical techniques and technologies, with the foundational principle that the lab will be fully technology enabled and paperless.
Strategic QC Chemistry oversight and leadership at the Company's Biologics start-up facility to meet functional and site goals and objectives.
Responsible for QC related testing for the site/Company's network (Analytical, Biochemistry, Utility and Raw Materials).
Hire, develop, lead and coach the QC team and drive a high performance organisational culture that accommodates rapid growth and highly dynamic expectations, ensuring attainment of site operational and development goals.
Responsible for adhering to domestic and international GMP regulations, cGMP's, company policies, leadership behaviours, performance and budget management.
Build safety as a value within the QC teams and maintain sustainable EHS programmes that are engrained within the department.
Lead the QC Chem lab through to routine operational testing with a passion for continuous improvement, new technologies and innovation
Responsible for QC oversight and compliance of analytical and biochemistry laboratory related commissioning, qualification and validation activities.
Responsible for ensuring that the QC, analytical and biochemistry laboratory test methods are qualified/validated as per corporate and site procedures.
Provides guidance to all relevant quality related events and direction to develop the area(s) technical and compliance capability along with long term strategic planning.
Maintains all laboratories in an inspection-ready, GMP-compliant state.
Ensures QC owned business systems are established and engage with the business systems owner to continually improve processes.
Sustained performance through lean leadership, robust learning and development planning, organisation talent reviews and communication planning.
Build partnerships within the Quality leadership team (QLT) to create and sustain a culture that demonstrates excellence in quality and continuous improvement.
Creates an environment of right first time in everything that we do through a focus on principles of lean, including simplication, standard work, visual management and a learning organisation.
Responsible for individual goal setting, ongoing performance reviews and development planning for direct reports and function.
Responsible for timely updates of site achievements and challenges. A collaborative approach, working cross-functionally on resolving obstacles to maintain a highly effective and productive functional group.
Responsible for ensuring compliance with legal, EHS and all Company policies and procedures which are applicable to the site.
Role model the behaviours that creates a culture of respect and dignity
Minimum of level 8 Bachelor's degree in a technical discipline (eg biochemistry, chemistry, microbiology) or equivalent.
At least 12 years' experience in the biotechnology and/or pharmaceutical industry, (preferably both).
Proven leader capability in developing people and teams with at least 8 years of
Proven ability around working cross functionally, focusing on meeting and tracking to schedules and embracing an interdependent work culture.
Experience working in a GMP/regulated environment.
Organisation Skills - Ability to manage multiple priorities and know when to escalate issues for resolution.
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