Job description:Your ResponsibilitiesKey member of the QC leadership team for WuXi Biologics Ireland. Will play an integral role in the strategy and business planning processes, ensuring cross functional collaboration and leadership execution.Work closely with all senior leaders to ensure work practises and targets are achieved in line with the business targets and objectives.The role will require extensive liaison with counterparts and business leaders in WuXi Biologics corporate to include the highest level of professional representation of the local site QC organisation.From a QC functional capacity support the design, construction, and commissioning of the new facility for the production of drug substance.Develop/build a world-class Biologics QC bioassays and biochemical assays product-testing team, including planning, recruiting/hiring, coaching/mentoring, and training for 15-20 total headcount.Provide the highest quality analytical support for Biologics manufacturing, while ensuring compliance with cGMP guidelines/regulations, company SOPs, and safety regulations.Interact with internal and external partners, clients, and inspectors and maintains high quality standards and servicesCommunicate, collaborate, and cooperate with QC functional teams and other departments to support lab start-up and routine operationsPrepare, review, and approve technical documents including method protocols, qualification and validation protocols and reports, etc.Serve as a technical lead supporting applicable non-conformances, atypical/OOS investigations, change controls, deviations, and CAPAs.Lead the group to meet the pre-determined goal/budget of the department through streamlining/optimizing the workflow and maximizing the operation efficient while maintaining full complianceProvide effective communication and play a leading role in project management interaction with internal and external clients such as Quality Assurance, Regulatory Affairs, and Analytical DevelopmentDevelop and maintain high level of scientific achievements for the company; expected to be a point of contact for project coordination, including email and client meetings.Introduce new technologies and seek opportunities for continuous process improvements/improved operational excellenceEnsure QC staff receive appropriate GMP training and maintain compliance and high quality standardsCreate a safety culture, enforce safety measures and ensure QC staff working in a safe environmentAbility to work in a team environment and independently as requiredEnsure the tasks associated with the start-up and routine operations applicable to the role are carried out in a safe mannerEnhance collaborations by sharing knowledge and experiences across WuXi Biologics global sitesWill be flexible to take on additional tasks and responsibilities at the discretion of the QC Director.Will act as a role model for the QC function and the wider organisation in adherence to the WuXi corporate core values and local site shared commitments/behaviours.Person SpecificationTechnical CompetenciesIdeally, experienced in establishing a QC function and building a team in a 'greenfield' context of similar size and scale.Technical expertise in tech transfer, validation, and troubleshooting Biologics product-testing methods, including cell based bioassay, PCR, ELISA, enzyme activity, Western Blot, SDS-PAGE, etc. to support QC release and stability testing in a GMP-environment according to USP, EP, and ChP requirements.Ability to handle regulatory inspections from FDA, EMA, etc. and GMP audits from clients, as well as internal Quality Assurance.Experience15+ years working within a Quality Control environment, with a well-rounded exposure to all areas in this field. Experience working in the Biologics industry is essential.Experience with LIMS, Empower, ECM, Master Control, Trackwise or similar systems is required.Experience with Microsoft Word, Excel, Powerpoint, Visio, and ProjectManagement/supervision of personnel with particular attention to schedules and shifting priorities is required and demonstrated leadership skillsPrevious experience in a Quality Control/GMP environment is requiredPrevious experience with regulatory inspections and internal/customer audits is strongly preferredPrevious experience working in a CMO is a plus.KnowledgeKnowledgeable of FDA/EMA regulatory requirements and ICH and GMP guidelines applicable to biologics and/or pharmaceuticals.QualificationsUniversity degree in related science/quality discipline required.Ph.D. with 5-8 years of experience, or Masters with 7-10 years of experience in Chemistry, Analytical Chemistry, Biochemistry, Biology, Molecular Biology, Engineering, IT, or another related field, desired.Behavioural CompetenciesExcellent interpersonal, verbal, and written communication skillsAble to think critically and demonstrate troubleshooting and problem-solving skillsSelf-starter and self-motivated; organized with good attention to detailComfortable working in a fast-paced environment and able to adjust workloads based on changing prioritiesResults oriented, with the ability to manage multiple priorities in a short period of timeSeniority level Director Employment type Full-time Job function Manufacturing, Quality Assurance, and Science Industries Biotechnology Research and Pharmaceutical Manufacturing