Head of Quality Control
Our client is a fast growing highly profitable multinational biopharmaceutical company with an exciting pipeline of drugs, undergoing a major expansion of its biologics facility in Ireland
- Strategic Quality Control oversight and leadership at the Biologics start-up facility to meet functional and site goals and objectives.
- Responsible for Quality Control related testing for the site / company network (Analytical, Biochemistry, Microbiology, Environmental Monitoring and Raw Materials).
- Hire, develop, lead and coach the Quality Control 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 Quality Control teams and maintain sustainable EHS programmes that are engrained within the department.
- Responsible for Quality Control oversight and compliance of laboratory related commissioning, qualification and validation activities.
- Responsible for developing the QC function into a ‘testing centre of excellence’ to support on site and network testing programs.
- Responsible for ensuring that the Quality Control laboratory test methods are qualified/validated as per corporate and site procedures.
- Responsible for generating all Quality Control related documents which include Standard Operating Procedures (SOPs), Protocols, Technical Reports and Deviation Reports.
- 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 Quality Control-owned business systems are established and engage with the business systems owner to continually improve processes.
- Leads the Quality Control department in meeting targeted site and Tech Ops quality objectives, ensuring department objectives are aligned, translated to all and visually managed to drive delivery.
- Sustained performance through lean leadership, robust learning and development planning, organisation talent reviews and communication planning.
- BuiId 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 comapany policies and procedures which are applicable to the site.
- Be an ambassador for the leadership behaviours of accountability, be positive, results driven and excellent manager of self and others.
- Role model the behaviours that creates a culture of respect and dignity in line with the Guide for ethical conduct.
- Responsible to act as an interface (in conjunction with the Head of Quality (QMR)) between new Site Quality and the supporting Central Quality support functions (ex. Central Product Testing, Clinical QA, Center QA Validation, and others) to ensure site support needs are met.
- Bachelor’s degree in a technical discipline (e.g. biochemistry, chemistry, engineering). A post-graduate qualification (MSc., PhD or MBA) is desired.
- At least 12 years-experience in the biotechnology and/or pharmaceutical industry, (preferably both).
- Proven people manager and leader capable of developing people and teams with at least 8 years of management experience.
- Track record of effective Quality Control leadership for internal production facilities with experience driving out inefficiencies and improving laboratory turnaround times.
- Proactive at keeping current with literature and latest technologies.
- A background in analytical methods (HPLC, ELISA, SDS-Page, Glyco analytic, Bio-Assays,
PCR, capillary electrophoresis and compendial assays). Knowledge of Analytical Method
Development, Analytical Method Validation and Statistical Quality Control. An excellent
understanding of GMP, ICH, USP and global compendia regulations and guidance’s,
particularly as related to analytical method development and validation.
- Experience leading, training and/or implementing root cause analysis and effective
- investigation practices.
- Experience with working in a multinational organisation.
Cv to email@example.com