Associate Director ESP Quality

IE02 (FCRS = IE002) Novartis Ireland Ltd; Dublin; Híbrido; EUR 73 000 - 135 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Flexible and hybrid working options

Minimum 14 weeks paid parental leave

Resumo da oferta

Novartis Ireland Ltd in Dublin is seeking an Associate Director External Service Provider QA to lead QA support for third-party qualifications and governance in a digitized trial environment.

The role requires expert QA knowledge across GxP, SaMD, and SaaS, with emphasis on risk monitoring, audits, and ensuring inspection readiness for health authorities. Hybrid working in Dublin is available.

Qualificações

• Extensive experience in pharmaceutical development and QA in vendor management.
• Bachelor's degree in Life Sciences, Pharmacy or Medicine; MSc/PhD preferred.
• Fluent English (spoken & written) and knowledge of GCP/GC LP, GVP, and medical device regs.

Responsabilidades

• QA SME support for Third Party qualifications and governance oversight.
• Assist qualification and governance teams in identifying potential risks with new Third Parties (GxP).
• Support clinical trial teams for trial-specific assessments to ensure technology fits study design.
• Review and approve quality issues related to Third Party and escalate major issues.
• Support assessment of serious breach and reporting to health authorities.
• Facilitate 'Quality with Technology' discussions with Third Party management to address quality challenges.
• Act as QA representative for cross-functional Digital Technology initiatives and Third-Party Quality activities.
• Participate in independent review of technology implementations ensuring inspection readiness and data integrity awareness.
• Ensure inspection readiness of outsourced activities and support audits/HA inspections.

Conhecimentos

Auditing

Audit Management

Vendor Management

Quality Management

Quality Assurance

Risk Management

Root Cause Analysis

Stakeholder Management

Technical Knowledge

Leadership

Organizational Savvy

People Management

Documentation

Regulatory Compliance

Quality Management Systems

Formação académica

Bachelor's degree in Life Sciences, Pharmacy or Medicine

MSc IT/Engineering/Scientific discipline

Ph.D. in Scientific/Engineering discipline

Descrição da oferta de emprego

Salary Range: €72,800.00 - €135,200.00

Job Description Summary #LI-Hybrid Location: Dublin, Ireland This role is based in Dublin, Ireland. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you.

As Associate Director External Service Provider QA, you will have an excellent opportunity to work as a liaison with the Novartis clinical trial teams and Third Parties to provide expert QA support during the Third-Party due diligence, qualification and on-going governance and monitoring. The use of various types of technology (i.e., DHTs, Medical devices, AI) continues to evolve for use in clinical trials. As such, the approach to qualification and oversight continues to evolve and change, requiring adaptive approaches and specialized skills.

Job Description Key Responsibilities

• QA support for technology-enabled (DHT, SaMD, SaaS) Third Party qualifications and governance oversight as a technical QA SME in the evolving digital and innovation landscape. This includes the initial qualification, routine risk monitoring and SME support during audits.
• Assist qualification and governance teams in identifying potential risks with new Third Parties, whether for GxP purposes or rapid ramp-up from exploratory to GxP use.
• As and when needed support the clinical trial team for trial specific assessment to ensure technology is fit for purpose based on specific study design.
• Responsible for review and approval of quality issues related to Third Party and ensure appropriate escalation of major and critical issues.
• Support assessment of serious breach and reporting to health authorities.
• Facilitate the ‘Quality with Technology’ discussions with Third Party management team other interested parties to promote greater understanding of quality challenges when working with tech enabled Third Parties and overcome them through improved collaboration and awareness.
• Act as QA representative for cross-functional Digital Technology initiatives, managing the overall Third-Party Quality activities.
• Participate in the independent review of technology implementations ensuring inspection readiness and data integrity awareness.
• Ensure inspection readiness of outsourced related activities and support for internal and external audits and health authority (HA) inspections pertaining Third Party management.

Minimum Requirements

• Extensive experience in pharmaceutical development and excellent knowledge of the quality management system, clinical operations processes and vendor management related activities is preferred.
• Minimum a bachelor’s degree in Life Sciences, Pharmacy or Medicine, M. Sc. IT/Engineering/Scientific discipline and/or Ph.D. in a Scientific and/or Engineering discipline preferred.
• Fluent English (both spoken & written)
• Working knowledge of GCP/GcLP, GVP, Medical Device regulations.
• Experience with clinical third-party management.
• Combination of computer system compliance and validation expertise associated with global IT systems development (SDLC) and implementation within the pharmaceutical and/or digital health technology (DHT).
• Broad knowledge of regulations and industry quality standards (GCP, ICH, FDA 21 CFR Part 11, FDA 21 CFR 820, ISO 13485).
• Expertise in implementing DHT/SAMD technology within innovative clinical trials preferred.
• Experience navigating complex problems and developing solutions within a matrixed environment.
• Demonstrated ability to partake in interdisciplinary projects with a wide range of business functions and successfully work in a global cross-functional matrix.

Benefits & Rewards

Expected Annual Base Salary Range for role: 72,800.00 -135,200.00 EUR The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically. In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. The rewards of being part of our team go far beyond base pay and incentives.

• insurance plans
• retirement plans
• wellbeing resources
• global recognition programs
• flexible and hybrid working options, where possible
• minimum 14 weeks paid parental leave

Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.

Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.

Commitment to Diversity and Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.

Skills Desired

• Auditing (Inactive)
• Audit Management
• Business Partnerships
• Continuous Learning
• Drug Development
• Employee Performance Evaluations
• Health Authorities (Inactive)
• Influencing Skills
• ISO 9001
• Leadership
• Organizational Savvy
• People Management
• Qa (Quality Assurance) (Inactive)
• Quality Management
• Quality Management Systems (QMS)
• Risk Management
• Root Cause Analysis (RCA)
• Self-Awareness
• Speed and Agility Training (Inactive)
• Stakeholder Management
• Technical Knowledge
• Vendor Management

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.