Job DescriptionGeneral Summary:Associate Director, Responsible Person (Ireland) holds responsibility in ensuring quality compliance in Vertex Affiliate Ireland and GxP principles and standards that Vertex Ireland must meet as the Marketing Authorization Holder and Wholesale Distribution Authorisation holder. This position holder has an oversight of the distribution network and will lead quality strategic QA initiatives associated with it. This role holder also acts as the RP at Vertex Ireland ensuring ongoing maintenance of the license, leading regulatory inspections, and support International Quality in wider regional or global projects.Key Duties:Act as Responsible Person (RP) on the Wholesale Distribution Authorisation (WDA) held by Vertex Pharmaceuticals (Ireland) Ltd, ensuring in partnership with the Deputy RPs, that operations are compliant with HPRA guide to Good Distribution Practice of Medicinal Products for Human Use and EU Guidelines of 5 Nov 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01). This role has the authority to take decisions with regard to their responsibilities.Support activities pertaining to the GMP-related responsibilities of Vertex Ireland as a Marketing Authorisation Holder (MAH) in compliance with Directive 2001/83/EC and Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. (Refer to * items below which may be duplicate to RP responsibilities). Provide QA leadership on projects related to distribution network improvementsKey Responsibilities:Ensuring that a quality management system is implemented and maintainedFocusing on the management of authorised activities and the accuracy and quality of recordsEnsuring that initial and continuous training programmes are implemented and maintainedCoordinating and promptly performing any recall operations for medicinal productsEnsuring that relevant customer complaints are dealt with effectivelyEnsuring that suppliers and customers are approvedApproving any subcontracted activities which may impact on GDPEnsuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in placeKeeping appropriate records of any delegated dutiesDeciding on the final disposition of returned, rejected, recalled or falsified productsApproving any returns to saleable stockEnsuring that any additional requirements imposed on certain products by national law are adhered toRemaining continuously contactable and available to attend the site as requiredEnsuring the WDA accurately reflects the current organisation, performing variations where necessaryPerforming review and approval of appropriate GxP documentation including procedures, work instructions, records and Quality AgreementsEnsuring audits and other qualification activities are performed for all outsourced activities to ensure their compliance to the applicable GxP requirementsLeading management review for Vertex IrelandParticipation in quality risk management activitiesParticipation in quality escalation meetings, providing input as an RP for Ireland and where required, notification to Health authorities of Quality DefectsManaging and approving change controls, deviations and CAPA where requiredPlanning and hosting Regulatory inspections (Providing front and backroom inspection support and leading post inspection follow-up with responses and CAPAs)Monitoring, assessing impact and communicating Regulatory Intelligence informationMaintaining knowledge of EU Good Distribution Practice, applicable Good Manufacturing Practice and local GDP/GMP guidancessupporting mechanisms to ensure supply of Medicinal productsEnsure clear delegation of responsibilities that include Product Quality Reviews (PQRs), the retention of samples, mechanisms to ensure product supply and the management of falsified medicinesActing as QA single point of contact with Irish and other European Health Authorities, ensuring relevant stakeholder involvement and timely correspondenceManage internal audits and support external audit scheduling, scope, and other qualification activities.Assessing and approval of applicable Periodic Quality Reviews (PQRs)Knowledge and Skills:Specialized depth of knowledge in GDP regulations, relevant to assigned region; broad knowledge of GMP and GVP regulationsDepth of experience in GDP and GMP auditingAbility to collaborate cross functionally across all levels of the organization with strong communication skills and the ability to persuade others to adopt a new point of viewSignificant experience in designing, developing and delivering effective trainingSkilled at using sophisticated analytical thought to inform decision-making and achieve results.Highly skilled at time management, prioritization of own work, and planning/organization skillsDemonstrates advanced ability to effectively communicate to local, international and global audiencesStrong experience in managing/leading others to include performance management and career developmentSkilled in technical writingEducation and Experience:Bachelor’s degree in a scientific or allied health field (or equivalent degree)Requires relevant work experience, or the equivalent combination of education and experiencePreviously has worked as the nominated RP on a European WDA#LI-SM2#LI-HybridFlex Designation:Hybrid-Eligible Or On-Site EligibleFlex Eligibility Status:In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select2. On-Site: work five days per week on-site with ad hoc flexibility.Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.Company InformationVertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com