Talent.com
Novartis UK
Clinical Quality Assurance - Program Lead (Associate Director)Novartis UK • Greater London, England, UK
No longer accepting applications
Clinical Quality Assurance - Program Lead (Associate Director)

Clinical Quality Assurance - Program Lead (Associate Director)

Novartis UK • Greater London, England, UK
30+ days ago
Job type
  • Full-time
Job description

Employment Type: Full‑time | Regular, Hybrid
Location: London (The Westworks) or Dublin (NOCC)
Relocation: Novartis is unable to offer relocation support for this role. Please only apply if the locations of Westworks, London or Dublin are accessible for you.

The Associate Director, Clinical Quality Assurance (QA) will provide Quality oversight for the end‑to‑end clinical process for the clinical trials under responsibility to ensure compliance with Health Authorities requirements, the internal standards, and full adherence to patients’ safety, rights, and well‑being.

Major Accountabilities

  • Proactively provide QA leadership to the business strategy for assigned programs/trials by ensuring considerable organization awareness (e.g., interrelationship of departments and business priorities).
  • Drive implementation of quality strategy within Global Clinical Team (GCT)/ Clinical Trial Team (CTT) under responsibility.
  • Regularly monitor the implementation of the annual Quality Plan pertaining to the assigned programs/studies.
  • Ensure adequate oversight of proactive quality risk management processes in the overseen areas, including quality risk assessments and submission/inspection readiness activities, and ensure that Clinical Trial Process (CTP) are in control.
  • Provide robust and clear quality oversight in the following areas of clinical development: support/collaborate with key stakeholders (e.g., Country Development Quality (CDQ), Development Units (DUs), GCT and/or CTT members) to ensure that risks are detected and remediated; support core governance for quality incident management for critical and major deviations pertinent to the programs being assigned and ensure timely escalation when required.; provide Good Clinical Practice (GCP) guidance to day‑to‑day questions arising from Clinical trials deliverables; collaborate with Country Development QA and External Service Providers (ESP) QA to drive initiatives relevant to internal monitoring and outsourced activities quality oversight; lead inspections preparation and facilitation in collaboration with other QA groups within Research & Development Quality (RDQ); support audits and inspections follow‑up activities including Corrective & Preventive Actions (CAPA) preparation.
  • Actively leverage audit/inspection outcomes/trends to sustain improvement in clinical trials conduct.
  • Active participation in continuous improvement initiatives (including workstreams) and ensure that areas identified as weaknesses are properly addressed and executed for sustainability.
  • Be QA point of contact for the defined trials and attend meetings to ensure quality is embedded in decision‑taking processes.

Essential Requirements

  • Bachelor’s degree in life science or healthcare field required. Advanced degree or equivalent education/degree in life sciences/healthcare preferred (PhD/MD/PharmD/Masters).
  • Extensive experience in regulated activities (GCP/Pharmacovigilance) and clinical development and/or QA positions with strong understanding of clinical trials.
  • Broad understanding of global expectations of Health Authorities in Clinical Development and profound understanding of the science of product development.
  • Ability to work independently and in a global/matrix environment.
  • Experience in managing projects.
  • Strong skills in GCP, quality and/or clinical development.

Benefits and Rewards

Learn about all the ways we’ll help you thrive personally and professionally.

#J-18808-Ljbffr

Create a job alert for this search

Clinical Quality Assurance - Program Lead (Associate Director) • Greater London, England, UK

Similar jobs

Director / Senior Director, Quality & Risk Management (Global Transaction Advisory Group)

Alvarez & MarsalGreater London, England, United Kingdom
Full-time

Director / Senior Director, Quality & Risk Management (Global Transaction Advisory Group).Alvarez & Marsal (A&M) is a global consulting firm with entrepreneurial, action and results-oriented profes... Show more

 • Promoted

Associate Director Biostatistics

Warman O'BrienLondon, England, GB
Full-time

Be among the first 25 applicants.Direct message the job poster from Warman O'Brien.Principal Biometrics Consultant @ Warman O'Brien Limited | Recruiting Statisticians.Join a leading global healthca... Show more

 • Promoted

Associate Scientific Director

LanglandGreater London, England, GB
Full-time

Langland, a Publicis Health company, is the only health communications agency that thinks further across Clinical Trial Experience, Medical Strategy & Education, Public Relations & Policy, and Adve... Show more

 • Promoted

Director of AI Transformation for Insurance & Risk

PwCGreater London, England, United Kingdom
Full-time

PwC is seeking a senior leader to shape and deliver the AI agenda for the insurance sector, spanning life and non-life insurers.You will lead a multidisciplinary team of actuaries, technologists an... Show more

 • Promoted

QA/Product Assurance Consultant (Space)

microTECH Global LTDGreater London, England, GB
Full-time

You will be actively involved in Product and Quality Assurance (PA/QA) activities across all phases of our programs—from design collaboration and risk assessment to investigative reviews during AIV... Show more

 • Promoted

Associate Director, Facility & Validation Quality

Orchard Therapeutics - U.S.Greater London, England, GB
Full-time

Director, Global Quality Compliance.Orchard Therapeutics, a Kyowa Kirin company, is a global gene therapy leader focused on transforming the lives of patients with rare disorders through innovative... Show more

 • Promoted

Director, Clinical Development – Global Vaccines

CEPI (Coalition for Epidemic Preparedness Innovations)Greater London, England, GB
Full-time

A global health organization is seeking a Director of Clinical Development to lead vaccine portfolio strategy and ensure compliance in trial execution.The ideal candidate will possess a medical deg... Show more

 • Promoted

Quality Assurance Manager

NoirGreater London, England, GB
Full-time

Show more

 • Promoted

UK Associate Medical Director – Strategy & ABPI Signatory

CytokineticsGreater London, England, United Kingdom
Full-time

Cytokinetics is seeking an Associate Medical Director to support the Senior Medical Director in shaping UK medical strategy for MYQORZO in obstructive hypertrophic cardiomyopathy.The role includes ... Show more

 • Promoted

Clinical Quality Assurance Director

Carrot RecruitmentGreater London, England, GB
Full-time

Founding Director, Carrot Recruitment, Pharma & Life Sciences Specialists.Clinical Quality Assurance Director – Innovative and fast-growing biotech – Cambridgeshire or Cheshire with hybrid working ... Show more

 • Promoted

QA Insights & Automation Lead — Data-Driven Assurance

Hastings DirectGreater London, England, GB
Full-time

Hastings Direct is seeking a Quality Assurance Insights and Automation Lead to shape how QA uses data, reporting and analytics to improve customer outcomes and risk visibility.You will own QA requi... Show more

 • Promoted

Associate Director, Syndicated Product Lead (Hybrid)

Marketing Management Analytics, Inc.Greater London, England, GB
Full-time

Ipsos iris is hiring an Associate Director - Product to lead syndi cated research product development and reporting interface enhancements.You will gather requirements, refine user stories, and coo... Show more

 • Promoted

Global Clinical Program Lead (Remote)

Randstad UKGreater London, England, GB
Remote
Full-time

A leading recruitment agency is seeking a Senior Clinical Project Manager to manage global pharmaceutical clinical trials.This role involves the end-to-end operational oversight of trials, particul... Show more

 • Promoted

Director, Feasibility

MedpaceGreater London, England, GB
Full-time

Proposals and Feasibility team.This position will evaluate and support new clinical trial opportunities by collaborating with Medpace Medical Experts, Clinical Trial Managers and our Regulatory Sub... Show more

 • Promoted

CMC Associate Director

AndrolabsGreater London, England, GB
Full-time +1

Location: Central London (office-based).Employment Type: Full-time, Permanent.Experience Level: Senior (10-14 years).Androlabs is a pharmaceutical company focused on men’s health.We aim to close th... Show more

 • Promoted

Director, Global Clinical Project Management

WEP ClinicalLondon, England, GB
Full-time

A leading healthcare firm in London is seeking an Associate Director of Project Management to lead project management teams and oversee Expanded Access Programs.The ideal candidate has a Bachelor's... Show more

 • Promoted

Senior Quality Assurance Lead

Just Group plcLondon, England, GB
Full-time +1

Direct message the job poster from Just Group plc.We help people achieve a better later life.That’s our purpose and it’s the reason we exist.We are a fast-growing FTSE 250 company helping customers... Show more

 • Promoted

Global Senior Director of RA/QA

Mantell AssociatesGreater London, England, GB
Full-time

Be among the first 25 applicants.Direct message the job poster from Mantell Associates.Mantell Associates is partnered with a rapidly growing CDMO, who is looking to expand their team with the addi... Show more

 • Promoted

Director QA, GMP External Operations Cell and Genetic Therapies - VCGT

Vertex PharmaceuticalsGreater London, England, GB
Full-time

OverviewThe Director, Quality Assurance GMP Operations is responsible for the end-to-end quality oversight of all product and activities at the Cell & Gene CDMO.Responsibilities include day-to-day ... Show more

 • Promoted

Associate Director - Health

Turner & TownsendGreater London, England, GB
Full-time

At Turner & Townsend we’re passionate about making the difference.That means delivering better outcomes for our clients, helping our people to realize their potential, and doing our part to create ... Show more