Lead and embed a culture of quality in clinical development; oversee compliance, continuous improvement, and quality initiatives globally.
Job Description Summary
#LI-HybridPrimary Location: Barcelona, Spain
Other Locations: Madrid, Spain, London, England, Dublin, Ireland
Join Novartis as Head Process Quality and lead the charge in embedding a culture of quality across clinical development. In this strategic role, you’ll partner with Business Process Owners to ensure compliance, drive continuous improvement, and shape quality initiatives that impact global development efforts.
If you're ready to influence change and elevate standards, we’d love to hear from you.
Job Description
Key Responsibilities:
- Champion a culture of quality across Development through strong partnerships and strategic influence
- Serve as the primary quality contact for Business Process Owners (BPOs)
- Lead regulatory gap assessments and ensure timely resolution of identified issues
- Guide BPOs and Quality System Owners in developing robust process change strategies
- Support audit readiness and contribute to comprehensive CAPA planning and execution
- Oversee implementation of audit and inspection CAPAs to drive continuous improvement
- Conduct regular reviews of quality and compliance topics within clinical processes
- Identify and mitigate risks while promoting opportunities for process enhancement
- Leverage data insights to drive excellence in clinical quality processes
- Contribute expert input to RDQ strategic initiatives and quality planning
- Bachelor’s or Master’s degree in Life Sciences, Nursing, Pharmacy, or Business Administration
- Fluent English communication skills, both spoken and written
- Minimum 10 years of Quality Assurance experience in regulated clinical development environments, including GCP
- At least 5 years of experience designing and implementing quality or business processes
- Proven ability to apply data-driven insights to improve quality and operational processes
- Demonstrated success in developing and executing global Corrective and Preventive Action (CAPA) plans
- Strong understanding of global regulatory expectations and clinical product development science
Skills Desired
Agility, Agility, Business Acumen, Business Partnering, Business Strategy, Clinical, Clinical Trials, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Drug Development, Employee Performance Evaluations, Health Authorities, Influencing Skills, Inspection Preparedness, Knowledge Of Gxp, Leadership, Organizational Savvy, People Management, Problem Solving Skill, Qa (Quality Assurance), Quality Management, Research, Risk Management, Root Cause Analysis (RCA) {+ 4 more}Top Skills
Capa
GCP
Quality Assurance
Novartis Dublin, Dublin, IRL Office
203 Merrion Rd, Dublin, Ireland, D04 NN12
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