Senior Manager, Clinical Quality EU or US (remote, full time)

Job purpose

The Senior Manager, Quality is responsible for leading the operational excellence and oversight of core Quality Management System (QMS) processes, including deviations, corrective and preventive actions (CAPA), risk management, audits and change control.
This role ensures that these critical processes are not only compliant with global and local GxP regulatory requirements (GCP, GVP, GEP, and others), but also consistently applied, scalable, and continuously improving across the organization.
As a key quality leader, the Senior Manager, Quality provides direction and oversight to Quality Managers responsible for the execution of QMS processes, ensuring high standards of performance, accountability, and consistency across teams and projects.
The role also plays a pivotal part in supporting organizational growth and integration, ensuring that quality processes remain robust, harmonized, and effective across newly integrated teams, systems, and ways of working.

Responsibilities

The responsibilities for the Senior Manager, Quality include, but are not limited to, the following:
QMS Process Management

• Oversees and leads the end-to-end execution and continuous improvement of core QMS processes, including:
  1. Deviations/Non-compliances
  2. Corrective and Preventive Actions (CAPA)
  3.  Risk Management
  4. Change Control
• Ensures these processes are:
  1. Applied consistently across teams, functions, and projects
  2. Efficient, risk-based, and aligned with regulatory expectations
  3. Designed to enable high-quality, inspection-ready outcomes

Quality Metrics and Monitoring

• Defines, implements, and monitors key quality metrics related to deviations, CAPA effectiveness, risk trends, and change management
• Translates data into actionable insights, identifying emerging risks, systemic issues, and improvement opportunities
• Drives data-informed decision-making to enhance QMS performance and maturity

Team Leadership

• Acts as line manager for Quality Managers, providing clear direction, coaching, and performance management
• Builds a high-performing team by developing capabilities, accountability, and ownership
• Ensures consistent and high-quality operational management of deviations, CAPA, risk management, and change control processes
• Promotes a strong culture of quality, continuous improvement, and collaboration across teams

Inspection Readiness

• Ensures that QMS processes under responsibility remain consistently inspection-ready
• Leads and hosts client audits and regulatory inspections, acting as subject matter expert for quality system processes
• Supports and/or conducts internal and vendor audits while ensuring timely and effective follow-up of audit observations and CAPAs
• Ensures processes are robust, traceable, and aligned with regulatory expectations

Audit and Quality Oversight 

• Plans and conducts internal and vendor audits, ensuring compliance with applicable GxP standards and company requirements
• Supports the qualification and oversight of vendors and partners, including audit execution and follow-up activities
• Evaluates audit outcomes, identifies systemic risks, and drives corrective and preventive actions
• Ensures effective tracking, closure, and reporting of audit findings and related actions

Business Support and Due Diligence

• Contributes to business development and client engagement activities by:
• Supporting company qualification questionnaires and client assessments
• Participating in due diligence activities and quality evaluations
• Providing input on quality capabilities, processes, and compliance frameworks

Integration Support

• Leads and supports the integration of newly acquired or merged organizations into the company QMS framework
• Ensures deviations, risks, and change controls related to integration activities are proactively identified, documented, and effectively managed
• Conducts and supports risk assessments, defining practical mitigation strategies during integration initiatives
• Drives harmonization and standardization of quality processes across diverse teams and operating models

Continuous Improvement

• Identifies and leads initiatives to improve efficiency, scalability, and effectiveness of QMS processes
• Collaborates with operational teams and cross-functional stakeholders to strengthen quality practices
• Drives process optimization and supports the ongoing evolution of the organization’s quality framework  

Experience - the ideal candidate will have

• Bachelor’s or advanced degree in Life Sciences or a related field
• Extensive experience in a GxP-regulated environment
• Strong expertise in GxP principles (GCP, GVP, GEP, etc.) and regulatory frameworks
• Proven experience in managing deviation/non-compliance, CAPA, risk management, and change control processes
• Extensive experience in hosting client audits and supporting regulatory inspections, as well as conducting internal and vendor audits
• Experience supporting business activities such as qualification questionnaires, due diligence, and client quality assessments
• Demonstrated experience leading, mentoring, or overseeing quality professionals
• Strong ability to analyse quality metrics, identify trends, and drive continuous improvement initiatives
• Proven ability to manage complex priorities with a high level of organisation and attention to detail
• Experience in cross-functional collaboration, stakeholder engagement, and regulatory interactions
• Strong problem-solving capabilities with a proactive and solution-oriented mindset

Experience - you must also have these skills

• Excellent communication and interpersonal skills, with the ability to influence and collaborate effectively
• Ability to work independently and proactively in a fast-paced, evolving environment
• Flexible and adaptable mindset, able to respond to changing priorities and business needs
• Strong organisational skills and attention to detail, combined with a high level of ownership and accountability
• Proficiency in Microsoft Office tools, with the ability and willingness to learn new systems and data tools
• Cultural awareness and the ability to work effectively across global, diverse teams and time zones

Why us?

You will join a young, very dynamic, and fast-growing private research organization. Our passionate, truly multicultural, and diverse team of nearly 500 colleagues and nearly 40 nationalities include epidemiologists, clinical operations, CRAs, CTAs, data scientists, statisticians, data analysts, medical writers, safety and pharmacovigilance specialists, project managers and business support professionals spreading over 20 countries. 
  
 We all work remotely, setting our own time schedule, based on a “getting the job done” mentality.  This has a positive impact in our work-life balance. Our headquarters are in Leuven (Belgium) as well as in Zeist (Netherlands), but we also have local and regional offices located in Bogota (Colombia), Johannesburg (South Africa), Bangkok (Thailand), Paris (France), Casablanca (Morocco) as well as Marietta and Durham (United States). You may need to travel occasionally. 
 
 At P95 & JC, we are a collaborative and international team that works on diverse projects, topics, and clients and faces interesting challenges. There is a high level of empowerment, flexibility, autonomy as well as opportunities for research and development, to make things happen. We have an open culture of respect and inclusion. Consequently, we value self-reliance, initiative, and responsibility of everyone in our team to meet our internal and external customers’ expectations. Finally, our colleagues experience a strong sense of meaning and purpose driven by the scientific nature and impact of our work.

Do you want to join us?

About P95

About us

P95 and Julius Clinical have recently joined forces, bringing together two highly complementary organizations with a shared mission: advancing global health through high‑quality epidemiological research and clinical trials.

P95, founded in 2011 and headquartered in Belgium, is a global leader in epidemiology, vaccines, and infectious disease research. With offices across Europe, North America, South America, Africa, and Southeast Asia, P95 supports public health agencies, pharmaceutical companies, academic institutions, and global organizations such as WHO and the European Commission. Our work focuses on generating timely, pragmatic, and actionable insights to improve access to safe and effective vaccines.

Julius Clinical, founded in 2008 and based in Zeist, The Netherlands, is a leading clinical CRO known for its strong scientific leadership and operational excellence. With more than 400 clinical trials conducted and over 300,000 participants enrolled worldwide, Julius Clinical specializes in central nervous system, cardio‑metabolic, renal, and rare diseases, working closely with biotech and mid‑sized pharma partners.

Together, we form a global, science‑driven organization offering an integrated portfolio of epidemiological and clinical research services. Our teams combine deep scientific expertise, operational excellence, and a shared passion for improving healthcare outcomes.

P95 and Julius Clinical are part of the Ampersand Capital Partners portfolio, a healthcare‑focused private equity firm.

We are united by a commitment to scientific rigor, innovation, and meaningful impact and we are excited to welcome new colleagues who share our ambition to improve global health.