Join to apply for the Head of Quality/RP role at ADVANZ PHARMA5 days ago Be among the first 25 applicantsJoin to apply for the Head of Quality/RP role at ADVANZ PHARMADirect message the job poster from ADVANZ PHARMASenior Talent Partner | Pharmaceutical | RecruitmentJob Title: Head of Quality/RP - IrelandLocation: DublinAbout ADVANZ PHARMAADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients’ lives by providing the specialty, hospital, and rare disease medicines they depend on.Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients.Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations.ADVANZ PHARMA’s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases.We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity.About the RoleLeadership and management of the GDP Compliance team and consultant RPsTo act as a named operational Responsible Person and Designated Person under the site wholesale distribution authorisation(s) and Active substance registration(s)To execute Responsible Person duties as per the EU Guidelines on Good Distribution Practice (2013/C 343/01), (2015/C95/01) and relevant local guidelinesMaintain effective and compliant Quality SystemKey responsibilities:Leadership and mentoring of the GDP Compliance and Contract RP teamsResponsible for Commercial Quality strategy and execution including WDA strategy, resourcing, and maintenanceEstablish and maintain systems, processes, and resources in accordance with business and GxP requirements for all areas of responsibilityEstablish quality objectives and KPIs (including reporting) for areas of responsibilityOversee and ensure readiness for inspections by Health Authorities associated with WDAs and ASRLead and support interactions with Health AuthoritiesLead major quality related incident resolution and provide guidance and solutions to technical and quality related issuesTo oversee systems and approve related documents (as necessary) for Deviations, Complaints, CAPA, Audits, Self inspection, Change Control, Customer Returns, Stock transfer request forms, Customer and Supplier Bona fide checks and Management ReviewFulfilment of the requirement of GDP guidelines and Routine Duties of a Responsible Person/ Responsible Person for Import/ Deputy Responsible Person (as appropriate) as laid down in EU GDP guidelines for Medicinal products for human use, EU GDP guidelines for Active substance and relevant local regulatory requirementsMaintain an open team culture focused on continuous improvement and talent developmentResponsible for identifying own training and development needs and ensuring Continued Professional DevelopmentActively participate as a member of the Quality Leadership teamBudgetary responsibility for relevant areas and ensure adherenceOther activities as may be required, at the discretion of managementAbout YouWe are looking for highly motivated individuals who are passionate about making a meaningful difference to patients’ lives.Qualifications:Minimum Bachelor’s Degree in Chemistry, Pharmacy, Life licenses or equivalentEligibility to fulfil the requirements of HPRA Good Distribution practice in respect of a Responsible Person/Designated PersonExperience & CompetencesMinimum 5 years’ experience of working in a similar role within a pharmaceutical company.Able to travel within Europe, or globally for Quality and/or Commercial and/or Technical project activitiesCapable of working to deadlines & remain calm under pressureProven ability to organize and prioritize multiple tasksAbility to work on own initiative & juggle prioritiesAbility to work effectively as part of a teamKnowledge & Skills:Proven managerial experience and ability to develop staffExcellent communication skills, both oral and written, to include senior management in third party suppliersWell organised with logical & methodical approach to workSound problem solving skillsGood organisation & time management skillsPersonal Qualities:Professional, methodical approach to work with ‘can-do’ attitudeHelpful & flexible with strong team spiritWhy ADVANZ PHARMA?The success of any company is driven by its people, and we are no different.At ADVANZ PHARMA, we believe in empowering our people to be entrepreneurs and embrace challenges to enable personal and company growth in an agile and fast-paced environment. We strive to do that inclusively and responsibly, treating all employees with integrity whilst rewarding outcomes and impact.Our teams are made up of people from all walks of life and backgrounds. We thrive in an environment where uniqueness is celebrated, but we are all united by the same passion to help improve patients' lives by providing and enhancing the specialty and hospital medicines they depend on.As a business, we like to tap into new ideas and fresh perspectives. So, if you join us, you’ll be empowered to own your work, explore new possibilities and make things happen.But there’s more to you – and us – than just work, which is why our culture, vision and values are so high on our agenda. We believe in gender equality and actively encourage women into senior roles – we have an active ADVANZ PHARMA Women’s Network; almost 40% of our managers are women.We work hard to recognise and reward talent, and we actively promote from within - last year, approximately 25% of our people across the company achieved promotions. In addition, we recognise talent with our annual Impact Awards, in which our top performers are rewarded for their hard work and dedication.We offer flexible, agile working options, and you will also enjoy a highly competitive salary and benefits package.To join us on our exciting journey, Apply now! **Please include a CV and Cover letter.ADVANZ PHARMA's Commitment to Equal Employment Opportunities: Our teams are made up of people from all walks of life and backgrounds. We thrive in an environment where uniqueness is celebrated. ADVANZ PHARMA is committed to providing equal employment opportunities for all employees and prospective employees without regard to race, color, religion, sex, age, national origin, ancestry, sexual orientation, marital status, disability, or other protected classifications to the extent required by applicable laws. In all instances, the company will continue to comply with all local laws governing employment practices. In addition, the company will make reasonable accommodation for any applicant or employee with a disability, both during the application process and on the job, whenever possible.Seniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeFull-timeJob functionJob functionQuality AssuranceIndustriesPharmaceutical Manufacturing and Biotechnology ResearchReferrals increase your chances of interviewing at ADVANZ PHARMA by 2xSign in to set job alerts for “Head of Quality Assurance” roles.Head of Quality - Design (Director Level)Dublin, County Dublin, Ireland 4 weeks agoSr. Director/VP, Quality Assurance, Biologics Manufacturing, Expat Opportunity in South KoreaHead of Quality, Patient Safety & Risk (full-time/permanent) GVIIIDublin, County Dublin, Ireland 3 days agoDublin, County Dublin, Ireland 1 week agoHead of Textiles Product Quality and ComplianceDublin, County Dublin, Ireland 2 weeks agoAssociate Director - Quality Oversight for Prospective BusinessesDublin, County Dublin, Ireland 1 month agoAssociate Director - Quality Oversight for Prospective Businesses,Dublin, County Dublin, Ireland 2 days agoDublin, County Dublin, Ireland 1 week agoSenior Quality Manager - Automotive TechDublin, County Dublin, Ireland 23 hours agoHead of Quality, Risk & Regulatory ComplianceDublin, County Dublin, Ireland 3 weeks agoDublin, County Dublin, Ireland 2 weeks agoDublin, County Dublin, Ireland 19 hours agoSenior Quality Assurance QA Specialist - 12 Month ContractDublin, County Dublin, Ireland 1 month agoDublin, County Dublin, Ireland 1 week agoDublin, County Dublin, Ireland 1 month agoAssociate Director, Client Oversight - Production Planning & Quality Process,Dublin, County Dublin, Ireland 13 hours agoAssociate Director - Risk Adjustment Coding Quality Business AnalysisDublin, County Dublin, Ireland 3 weeks agoDublin, County Dublin, Ireland 1 month agoWe’re unlocking community knowledge in a new way. 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