Associate Director Medical Qa

3 days ago

Dublin, Dublin City, Ireland Novartis Farmacéutica Full time

Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people's lives.

To do this, we are optimizing and strengthening our processes and ways of working.
We are investing in new technologies and building specific therapeutic areas and platform depth and capabilities – all to bring our medicines to patients even faster.

We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to.

Apply today and we can thrive together

This role will be based in Dublin, Ireland in a hybrid working approach.
About the RoleAre you ready to become the Associate Director, Medical Quality Assurance?
You will safeguard quality and compliance in the medical environment for key medical activities focusing on strategic and operational governance provided to Global Medical Affairs, Global Clinical Operations and Patient Safety & Pharmacovigilance.
This means providing strategic quality oversight to ensure compliance with the Health Authorities requirements, the internal standards and a full adherence to patients' safety, rights and well-being.
The incumbent will undertake risk analysis, take critical decisions together with internal stakeholders, ensuring clinical/medical trials have no delays whilst maintaining high quality level data.
So, if taking full ownership of the quality aspects of the assigned clinical trials, leads the due diligence efforts for assigned programs and drive a culture of quality then this role sounds very suited to you.
Major accountabilities but not limited to: Ensure adequate quality oversight for all GxP and regulatory obligations for Interventional Studies (INT), Non-Interventional Studies (NIS), Managed Access Programs (MAPs), Investigator Initiated Trials (IITs) and Research Collaborations (RCs).
Strong business collaboration, paying specific attention to the interfaces with GMA and PS&PV.Provide quality support and oversight for supported activities by e.g.
actively participating in respective governance or other boards as appropriate.Contribute quality advice and input to the development and implementation of the annual Quality Plan related to supported activities.Contribute quality expertise to processes, systems and standards related to supported activities to ensure compliance to Novartis requirements and to sustain compliance excellence.Support inspection and audit activities in covered areas as assigned.
Assist with support of Health Authority inspections.Provide quality and compliance support and guidance during the development and execution of corrective and preventive actions (CAPA), as follow-up to inspection and audit findings or any other activities identifying quality and compliance gaps to current or future regulatory requirements and Novartis standards.Provide quality expertise to the management of quality issues, deviations and escalations in the supported areas including investigation and root cause analysis.
Review and approve the content of quality issues, deviations and escalations with relevant actions and approve action closure.Key performance indicators: Quality processes, systems and standards for business partner activities are supported.Quality and compliance support is adequately provided for business partners' governance activities.Your Experience:Degree in Life Sciences or related scientific discipline.
Higher degree desirable.Excellent written and verbal English communication skills.At least 8 years QA / PV / clinical / regulatory affairs / pharmaceutical industry / Health Authority experience.GCP/PV auditing or inspection experience and Health Authority interactions a plus.Experience in QA governance a plus.Ability to travel to support inspections.Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision; excellent problem solving, decision making and prioritization skills.Quality mindset and excellent quality and compliance leadership and facilitation skills.Extensive knowledge of GCP, GPP and PV regulations, guidelines and policies.Ability to lead teams and operate successfully in various team capacities and diverse cultural environments.Ability to deputize for the Global Head Medical QA as needed.Why Novartis: Helping people with disease and their families takes more than innovative science.
It takes a community of smart, passionate people like you.
Collaborating, supporting, and inspiring each other.
Combining to achieve breakthroughs that change patients' lives.
Ready to create a brighter future together?
Commitment to Diversity & Inclusion:Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

#J-18808-Ljbffr

  • Associate Clinical Development Medical Director

    3 weeks ago

    Dublin, Dublin City, Ireland Novartis Farmacéutica Full time

    Associate Clinical Development Medical DirectorJob ID REQ-10030826Feb 04, 2025IrelandSummaryThe Associate/Clinical Development Medical Director (CDMD) is responsible for leading the planning and management of the assigned RLI clinical program(s) to support the RTL trials from an end-to-end clinical development perspective. As CDMD, you will have oversight of...

  • FS Tax Directors

    7 days ago

    Dublin, Dublin City, Ireland Director File Full time

    We are working with the head of FS tax to help hire a Financial Services Tax Directors and Associate Directors to join their rapidly growing financial services tax team.Our client is the fastest growing firm in Ireland and has over 3000 people in 10 offices across Ireland, the Isle of Man, Gibraltar, and Bermuda, with a presence in over 130 countries around...

  • QA Director

    2 weeks ago

    Dublin, Dublin City, Ireland Playrix Full time

    QA Director We are looking for a candidate for the QA Director position who has a high level of technical knowledge and is ready to help improve the quality of our games. Your task will be to manage the testing team and develop leaders, as well as to implement new testing processes on our projects and improve existing ones. You will have the opportunity...

  • Associate Director, Medical Information

    6 days ago

    Dublin, Dublin City, Ireland Jordan martorell s.l. Full time

    Job DescriptionTHE POSITION:Medical Information is a critically important customer-facing function that supports the safe and effective use of pharmaceutical company products by providing timely, scientifically balanced, evidence-based, non-promotional information in response to unsolicited requests from healthcare professionals, patients, caregivers, and...

  • Director Qa Engineering

    7 hours ago

    Dublin, Dublin City, Ireland Fidelity Investments Full time

    Job Description: The Workplace Investing Quality Engineering (QE) team is seeking a multifaceted, forward-thinking organizational leader who is passionate about the customer and committed to quality.Strategic mentality coupled with technical competence of Quality practices drives our ideal candidate toward execution and delivery, while they lead a...

  • Associate Director Quality Standards

    10 hours ago

    Dublin, Dublin City, Ireland Novartis Farmacéutica Full time

    Job OverviewNovartis is seeking a highly experienced professional to lead the implementation of quality standards and processes for external service providers. As Associate Director External Service Provider QA, you will be responsible for reviewing and approving ESP qualifications, negotiating quality agreements, and collaborating with business...

  • QA Director

    1 week ago

    Dublin, Dublin City, Ireland Scopely Full time

    Scopely is looking for a QA Director to join our unannounced project in Barcelona, Spain, Dublin, Ireland, Portugal or the UK on a hybrid or remote basis. We can support with visa sponsorship and relocation assistance.At Scopely, we care deeply about what we do and want to inspire play, every day - whether in our work environments alongside our talented...

  • QA Director

    3 weeks ago

    Dublin, Dublin City, Ireland Griffin Gaming Partners Full time

    Scopely is looking for a QA Director to join our unannounced project in Barcelona, Spain, Dublin, Ireland, Portugal or the UK on a hybrid or remote basis. We can support with visa sponsorship and relocation assistance.At Scopely, we care deeply about what we do and want to inspire play, every day - whether in our work environments alongside our talented...

  • QA Director

    3 weeks ago

    Dublin, Dublin City, Ireland Griffin Gaming Partners Full time

    Scopely is looking for a QA Director to join our unannounced project in Barcelona, Spain, Dublin, Ireland, Portugal, or the UK on a hybrid or remote basis. We can support with visa sponsorship and relocation assistance.At Scopely, we care deeply about what we do and want to inspire play every day - whether in our work environments alongside our talented...

  • Associate Director QA

    5 days ago

    Dublin, Dublin City, Ireland Amgen Full time

    Position: Associate Director, Quality and Primary QP Overview: The Primary QP role involves acting as the main Qualified Person (QP) on the Amgen Technology Ireland (ATI) manufacturing license. This position provides scientific, quality, compliance, and patient-centered support to the ATI manufacturing site. It includes supporting daily Quality activities...

  • Clinical Development Medical Director – Dermatology

    5 days ago

    Dublin, Dublin City, Ireland Ie02 (Fcrs = Ie002) Novartis Ireland Ltd Full time

    Summary As our Clinical Development Medical Director in our Immunology Development Unit you will be responsible for the scientific and clinical strategy of assigned clinical trials, scientific monitoring, and reporting of quality data.About the Role The Clinical Development Medical Director (CDMD) for Dermatology is the clinical leader of defined program...

  • Associate QA Specialist

    6 days ago

    Dublin, Dublin City, Ireland Life Science Recruitment Full time

    Associate QA Specialist (Shift)AMC2071111 MonthsCarlowWe're currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.Duties:Review and approval of all manufacturing batch...

  • Associate Director

    1 week ago

    Dublin, Dublin City, Ireland Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Associate Medical Officer

    10 hours ago

    Dublin, Dublin City, Ireland OASIS Group Full time

    We are seeking a dedicated and compassionate Associate Medical Officer to join our team at OASIS Group. As an associate medical officer, you will be responsible for providing high-quality medical care to patients and families, working closely with our multidisciplinary team to deliver exceptional patient outcomes.About the RoleThis is an exciting opportunity...

  • Associate QA Engineer

    3 weeks ago

    Dublin, Dublin City, Ireland Propylon Full time

    Are you interested in joining an innovative, software solutions business dedicated to driving digital transformation?We have an exciting opportunity for an Associate QA Engineer with an interest in automated testing to join our team, working across major client projects and internal products. This candidate will join a small, focused Quality Engineering team...

  • Associate QA Engineer

    2 weeks ago

    Dublin, Dublin City, Ireland Propylon Full time

    Are you interested in joining an innovative, software solutions business dedicated to driving digital transformation?We have an exciting opportunity for an Associate QA Engineer with an interest in automated testing to join our team, working across major client projects and internal products. This candidate will join a small, focused Quality Engineering team...

  • QA Engineer

    3 weeks ago

    Dublin, Dublin City, Ireland Rue Gilt Groupe Full time

    THE ROLE: QA EngineerWe're looking for…A rare opportunity to join our incredibly talented QA team and have a massive impact supporting two of the top private sale e-commerce destinations, Rue La La and Gilt. As a QA Engineer, you will help ensure the quality that our 30M+ loyal members demand as we launch new, innovative features powered by Store Manager,...

  • QA Senior Associate

    2 weeks ago

    Dublin, Dublin City, Ireland Recruitment by Aphex Group Full time

    This is a 12-month contract with a strong view to extension.PurposeThe Plant Quality Assurance (PQA) Snr Associate will report to the QA Manager and will be a core member of the site Quality Assurance team. The PQA Snr Associate will serve as Quality point of contact for manufacturing operations.The site is focused on continuous improvement of all work...

  • Medical Director

    4 hours ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Job DescriptionCpl Healthcare is seeking a highly skilled Medical Director, Global Drug Safety and Pharmacovigilance to join our team.Duties and ResponsibilitiesThe ideal candidate will be responsible for implementing and coordinating safety surveillance procedures for products. This includes:Developing and leading safety activities and benefit-risk...

  • Associate Director

    1 week ago

    Dublin, Dublin City, Ireland First Recruitment Group Full time

    Associate Director / Director - Project Management (Rail Upgrade and Engineering Projects)Location: Ireland Sector: Transport Job Type: Permanent Salary: Negotiable depending on experience Reference: SK/R/090369RoleSenior Rail Engineering Leader – Major Infrastructure ProjectsLocation: Dublin, Dundalk, Cork, or GalwayWe are searching for a high-calibre...