Associate Director ESP Quality

Novartis; Greater London; Hybrid; GBP 64,000 - 119,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition

Hybrid working

Parental leave

Job summary

Novartis in London is seeking an Associate Director External Service Provider QA to lead QA oversight of third-party technology providers in clinical trials.

You will act as a QA SME across due diligence, qualification and ongoing governance, ensuring GxP compliance, data integrity and inspection readiness in a global, matrixed environment.

Qualifications

• Extensive experience in pharmaceutical development and quality systems.
• Fluent English (spoken & written).
• GCP/GcLP, GVP, Medical Device regulations knowledge.

Responsibilities

• QA support for Third Party qualifications and governance oversight as a technical QA SME.
• Assist qualification and governance teams in identifying risks with new Third Parties.
• Support clinical trial teams for study design assessments of technology fit.
• Review and approve quality issues related to Third Party activities and report major issues.
• Lead 'Quality with Technology' discussions with Third Party management to improve collaboration.
• Act as QA representative for Digital Technology initiatives across functions.
• Participate in independent reviews of technology implementations for inspection readiness.

Skills

QA governance

Clinical trial QA

Vendor management

DHT/SaMD QA

Regulatory knowledge

GxP compliance

English fluency

Education

Bachelor's degree in Life Sciences/Pharmacy/Medicine

M.Sc IT/Engineering/Scientific discipline

Ph.D. in Scientific/Engineering

Job description

Job Description Summary

Salary Range: £63,917.00 - £118,703.00

#LI-Hybrid

Location: London, UK

This role is based in London, UK. 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.

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

At Novartis, we're committed to reimagining medicine together - and rewarding the people who make it happen.

Expected Annual Base Salary Range for role: 63,917.00 - 118,703.00 GBP

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. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and 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 ar