This job is with Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job FunctionQualityJob Sub FunctionQuality AssuranceJob CategoryProfessionalAll Job Posting Locations:Little Island, Cork, IrelandJob DescriptionPOSITION SUMMARY: This position is responsible for controlling batch release as per Annex 16 to the EU Guide to Good Manufacturing Practice.General Scope Of ResponsibilitiesResponsible for certifying DSP batches prior to release to filling siteEnsures that product manufacturing, testing and release comply with applicable regulatory requirements and specifications prior to product releaseMaintains oversight of Quality issues and change controls, ensuring that any issues that have a regulatory impact are notified to health authorities and mitigated as requiredAttends QMR review meetings to ensure that the quality system continues to function effectively and that improvement/remediation actions are taken as requiredMaintains knowledge and understanding of quality oversight for services and operations which are outsourced to CMOs / contract test labsMaintains Qualified Person (QP) knowledge and experience up-to-date. If a new product type is introduced the QP must ensure that they have gained the relevant knowledge and experience necessary to complete QP duties.Maintains oversight of issues/escalations related to batches post release ensuring that appropriate actions are taken as required.Supports QA colleagues with product quality / license impact assessment for Quality Issues.Review and approval of Quality documentation associated with product manufacture.Key Competencies RequiredExcellent interpersonal skillsManagement skills: Problem solving; statistical thinking; design of experimentsKeeps up-to-date with the regulatory, technical developments in the industry that will affect products on-siteExcellent attention to detailMaintains focus on patients and customers at all timesMaintains the highest standards of ethical behaviorQualifications And Experience (essential)Have fulfilled the educational requirements as outlined in Article 49 of Directive 2001/83/EC with at least 2 years Qualified Person experience within regulated biologics / pharmaceutical industryKnowledgeable of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals.Ability to apply GMP regulations and other relevant international guidelines to all aspects of the position.Required SkillsPreferred Skills:Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)