Quality Lead, Biologics Dublin
Our client is a fast growing highly profitable multinational biopharmaceutical company with an exciting pipeline of drugs
This role will serve as the lead for all Quality activities at the company Biologics manufacturing site in Ireland. The overall responsibility of this role is to design and execute the strategy for compliance to Good Manufacturing and Good Distribution Practices for all Irish operations in accordance to company global standards.
Responsibilities include QA oversight and compliance of commissioning, qualification and validation activities during the development of the site. Responsible for establishing and hiring the Quality organization (QA and QC) at the site.
Quality system implementation and management of (change control, CAPA and deviations); audit support; plant QA operations; internal product technology transfer; and facility compliance. Responsible for bulk drug substance manufacturing/ testing oversight and final lot disposition for commercial and clinical (DS specific) use. Responsible for review and approval of site validation activities. Responsible for Quality Control site testing including raw materials, environmental monitoring, and microbiology and oversight of related investigations. Responsible to act as a primary interface in conjunction with the Head of Quality - Biologics between Irish Site Quality and the supporting Central Quality support functions (ex. Central Product Testing, Clinical QA, Centre QA Validation, and others) to ensure site support needs are met as well as adherence to global standards.
Sets strategy to enhance and maintain Biological Quality globally including oversight of:
• Strategic oversight and leadership to meet functional and site goals and objectives
• Responsibility for adhering to domestic and international GMP regulations, cGMP’s, , company policies, leadership behaviours, and performance and budget management
• Responsible for QA oversight and compliance of site commissioning, qualification and validation activities.
• Hire, develop, lead and coach the Quality team and drive a high performance organizational culture that accommodates rapid growth and highly dynamic expectations
• Responsible for timely updates of site achievements and challenges to management with a focus on quality compliance, operations performance, staff performance and productivity, staff development, continuous improvements, key projects support and identification and resolving obstacles to maintain a highly effective and productive functional group.
• Interact regularly with customers to meet the needs and communicate activities and issues to line Management on a regular and timely manner
• Execution of product disposition (drug substance)
• Ability to lead complex material review boards to determine the ultimate outcome of complex deviations/dispositions which are based on data, science, and compliance
• Responsible for implementation of the Quality system and accountable for quality oversight of quality management systems (CAPAs, Change Controls, Deviations)
• Responsible for Quality Control related testing and sampling for site (Microbiology, Environmental Monitoring, Raw Materials) as well as quality assurance review of site validation activities
• Development and refinement of groups’ quality systems and procedures
• Champion site metrics to ensure targets are achieved, met and countermeasures in place when applicable,
• Assuring appropriate GMP and QA systems training of QA personnel and customers
• Responsible for site specific QMR management and gathering of APQR data
• Preparing for/ supporting/ leading regulatory inspections and third party audits
• Providing information to regulatory submissions as necessary
• Creation and management of the Site Master Files & management of site licensures
• Leading and/or representing Quality on multidisciplinary teams
• Responsible for timely hiring, training and development of qualified staff to ensure effective execution of roles and responsibilities, GMP compliance, and attainment of operational and development goals.
• Maintaining daily staffing requirements to meet business needs.
• Responsible for continuous improvement on an ongoing basis to proactively mitigate current and future risks to maintain an effective operation to support business needs.
• • Executing company policies
• Ensuring self inspections are performed
• Escalating and ensuring risk champions are established
• Ensures new/revised quality system requirements are deployed to the Site
• Ensures execution leads for Quality-owned business processes are established who work with the business process owner to continually improve processes.
Education & Experience Requirements:
The ideal candidate will have the following education and experience
• Degree in technical discipline such as biochemistry, chemistry, engineering
• Advanced degree in complimentary field of study (preferred?)
• At least 12 years of experience in the biotechnology and/or pharmaceutical industry, preferably both
• Experience leading teams
• Proven people manager and leader capable of developing people and teams with at least 8 years of management experience.
• Track record of effective Quality leadership for internal production facilities, testing, sampling, and product disposition
• Experience in providing Quality oversight for engineering and validation projects supporting internal operations and tech transfer activities
• Experience leading, training and/or implementing root cause analysis and effective investigation practices
• Strong operations background to ensure value added and effective quality operations. Experience driving out inefficiencies and improving turnaround times
• Understands regulations pertaining to licensing, import/export, and transportation requirements. (GDP activities…per comments made above)
• Experience applying appropriate regulations in emerging markets and/or where requirements are ill defined or ambiguous
• Working in a multinational organization effectively navigating differing regional expectations
Other Job Requirements:
Domestic and International Travel will be required up to 20%
Cv to Gerry@rftgroup.ie