Biotech QA Manager – External Suppliers – Remote

Job title: Biotech QA Manager – External Suppliers – Remote

Company: JobContax


Job description: Biotech QA Manager – External Suppliers – RemoteOffice/Project Location: Dun Laoghaire, DublinEmployment Type: ContractWork Location: RemotePay: €60 – €70 per hourExperience: 10+ yearsVisa: EU passport or Stamp 4 visa requiredOur client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoighaire, South Dublin.The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.This is an excellent opportunity to get experience into Ireland’s leading aseptic manufacturing plant.Quality and Compliance Oversight of a contract lab, CMO or a raw material SRE. Alignment with CTA / Marketing Application.Be an integral quality member of cross-functional contract manufacturing team that includes but is not limited to business operations, analytical science, process development, supply chain XPD etc.Negotiator and Approver of quality agreementsLead the preparation of the site for and Represent Amgen at product-specific Regulatory Inspections and/or during Notified Body audits of CM Site, as applicable or required.Present on topics during inspection demonstrating appropriate behaviors and knowledge of the subject areasReview / Approve Master Batch RecordsQuality approver for deviations, change controls, CAPAPrepare inspection playbooksIdentify and mitigate Risk at the CMO or testing Laboratories and/or escalate to managementPerform Person in Plant activities as requiredAPR Data ProviderManage Audit commitments to completionPerform tactical batch disposition activities in support of lot releaseDecision to release or Reject batches (Dynamic is different for SREs)Decision to approve or reject deviations, Change Control, CAPADecision to approve QAGRProvide Quality position on GMP related topics and strategy for the siteDecision to approve Master batch Records/Raw Material SpecificationsRequirementsDoctorate degree & 2 years of directly related experience ORMaster’s degree & 4 years of directly related experience ORBachelor’s degree & 6 years of directly related experience OR10 + years biotech or pharmaceutical industry experienceAdditional European Languages – desirable not essentialSignificant Quality experience at Aseptic Manufacturing facilitiesAble to facilitate and influence senior stakeholders and partnersAble to successfully manage workload and timelinesFamiliarity with basic project management toolsAbility to negotiate a strategic position after taking feedback from multiple sourcesStrong project management, problem-solving, and analytical skillsDemonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality resultsCollaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolutionAbility to operate in a matrixed or team environment with site, functional, and executive leadershipExperience driving decision making by using DAI principlesExperience with the “variation management” processSomebody who can be autonomous and doesn’t need a huge amount of day-to-day hand holdingThey really need to hit the ground running as much as they canWilling to get involvedWe would be looking for candidates with a very strong quality mindset because they may not be the person that has all the answers, but they will be the one who has taken the information from the CMOs and work at who do you need to involve them from a company perspective?So would need a good oversight of deviation management, reg affairs, filings, regulatory, the guidance, e.g., HPRA requirements, so a very broad experience in quality.Somebody who has worked in an external manufacturing environment.PackageContract role – Hourly rate €60 – €70 per hourMinimum 12 month contractOnsite expectations: Fully remote.There could be requirements to go on to site in Dun Laoghaire as that’s the location the team are aligned to, but onsite expectations are not on a regular frequency.We anticipate that we would need the individual to come onsite at least once a quarter, and there could be the occasional ad-hoc requirement to go onsite.Travel: We do not foresee a huge amount of travel but feel it’s worthwhile flagging and the travel extends to Europe.ContactKaren McHugh is the consultant managing this position.If you are a Biotech QA Manager interested in roles based in Dublin , you can contact Karen by e-mail at [email protected] Karen or phone 353 1 9696683 for a confidential chat.JobContax do not send CVs to clients without candidate permission.With over 50 years of technical recruitment experience, JobContax is the leading recruiter of Biotech QA Managers in Dublin and Ireland.Due to the large volume of applications, JobContax may not be able to respond to every individualstaglife

Expected salary:

Location: Dublin

Job date: Sun, 18 May 2025 22:26:05 GMT

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