Senior Manager CQA

Pharming Technologies B.V.; Leiden; On-site; EUR 120,000 - 160,000; Full time

Benefits offered by this job

8.33% holiday allowance

30 vacation days

Pension plan

Job summary

Pharming Technologies B.V. in Leiden seeks a Senior Manager Clinical Quality Assurance to provide strategic and operational leadership for clinical and pharmacovigilance quality.

You will ensure GCP/GVP oversight, risk-based quality management, and inspection readiness across the product lifecycle. You will lead the CQA team, partner with Clinical Development, Regulatory, Pharmacovigilance and external vendors to safeguard participant safety, data integrity and regulatory compliance.

Qualifications

• Master’s degree in a life sciences field or related discipline with extensive QA expertise.
• Minimum 8 years in the pharmaceutical/biotech industry with GCP/GVP responsibility.
• Strong knowledge of global GCP/GVP requirements and regulatory guidance.
• Experience leading teams and managing cross-functional projects.
• Experience planning and conducting GCP/GVP audits and regulatory inspections.

Responsibilities

• Provide independent GCP and GVP oversight for clinical development and pharmacovigilance activities.
• Own and oversee lifecycle management of QA documents, standards and procedures.
• Advise study teams on quality-by-design and risk-based controls.
• Oversee eTMF quality and trial documentation.
• Lead risk assessments and drive continuous improvement.
• Manage audit programs and vendor oversight; ensure timely remediation.

Skills

GCP/GVP knowledge

Audits

People leadership

Regulatory compliance

Communication

English language skills

Education

Master’s degree in life sciences / pharmacy / medicine

Bachelor’s degree with substantial relevant experience

Tools

eTMF platforms

Electronic Quality Management Systems (QMS)

Job description

The Role

The Senior Manager Clinical Quality Assurance (CQA) provides strategic and operational leadership for clinical and pharmacovigilance quality. The role is accountable for independent GCP and GVP oversight, a risk-based quality management approach, inspection readiness and the effective operation of the clinical quality management system, in compliance with Pharming Sop’s and all applicable regulations and guidelines (e.g. FDA, EU, ICH and national).

The Role

The Senior Manager Clinical Quality Assurance (CQA) provides strategic and operational leadership for clinical and pharmacovigilance quality. The role is accountable for independent GCP and GVP oversight, a risk-based quality management approach, inspection readiness and the effective operation of the clinical quality management system, in compliance with Pharming Sop’s and all applicable regulations and guidelines (e.g. FDA, EU, ICH and national).

The Senior Manager CQA leads and develops the CQA team and partners with Clinical Development, Medical Affairs, Pharmacovigilance, Regulatory Affairs and external service providers to safeguard participant safety, data integrity and regulatory compliance across the product lifecycle.

Areas Of Responsibility

People leadership and team performance

• Lead, coach and develop the CQA team; establish clear objectives, roles, priorities and decision rights.
• Ensure team members are appropriately qualified and trained, with individual development plans and succession considerations.
• Create an inclusive, psychologically safe and high-performing environment in which workload, wellbeing, accountability and delivery are actively managed.
• Monitor capacity, timelines and performance indicators; escalate resource or delivery risks in a timely manner.

Clinical and pharmacovigilance quality oversight

• Provide independent GCP and GVP oversight for clinical development and pharmacovigilance activities, including oversight of outsourced activities.
• Own or oversee the review, approval and lifecycle management of clinical and pharmacovigilance quality-system documents, standards and procedures.
• Advise study teams on quality-by-design, critical-to-quality factors and proportionate, risk-based controls throughout study planning, conduct and close-out.
• Oversee the quality and integrity of trial documentation, including risk-based reviews of the electronic Trial Master File (eTMF) and related systems.

Quality risk, issues and continuous improvement

• Facilitate and challenge quality risk assessments; ensure significant risks are visible, owned, mitigated and monitored.
• Identify trends and systemic issues using quality metrics, audit outcomes and inspection intelligence; sponsor sustainable improvement actions.
• Assess the impact of new or revised regulations, guidelines and industry expectations and coordinate timely implementation within the quality system.

Audit, vendor oversight and inspection readiness

• Develop and maintain a risk-based audit program covering investigator sites, CROs, safety vendors, laboratories and other GxP service providers.
• Lead or oversee GCP, GVP and relevant GLP audits; communicate findings clearly and ensure timely, risk-appropriate remediation and closure.
• Maintain continuous inspection readiness through governance, mock inspections, document readiness, interview preparation and action tracking]Act as a lead CQA representative during regulatory inspections and health-authority interactions, coordinating responses and commitments.

Stakeholder partnership and governance

• Serve as the primary CQA point of contact and trusted advisor for Clinical Development and operations, Pharmacovigilance, Regulatory Affairs and other relevant functions.
• Participate in cross-functional projects, providing independent quality judgement and escalating significant compliance or patient-safety concerns.
• Build effective quality relationships with external partners and suppliers; define expectations, performance measures and escalation pathways in quality agreements.
• Prepare concise quality updates, risk summaries and management reports for senior stakeholders and quality governance bodies.

Your Profile

Qualifications & experience:

• Master’s degree in life sciences, pharmacy, medicine or a related discipline, or a bachelor’s degree with substantial relevant experience.
• At least 8 years of experience in the pharmaceutical or biotechnology industry, including at least 6 years in Quality Assurance with significant GCP and/or GVP responsibility.
• Strong working knowledge of global GCP and GVP requirements and relevant clinical-development regulations and guidance, including expectations for data integrity, computerized systems and outsourced activities.
• Demonstrated experience leading people, projects; direct line-management experience is strongly preferred.
• Proven experience planning and conducting GCP/GVP audits and supporting or leading regulatory inspections. Lead-auditor training is an advantage
• Experience with electronic quality-management systems and eTMF platforms.
• Explains quality expectations clearly, manages challenging conversations. Can be both persistent and flexible to adapt in a new situation.
• Language requirements: Fluent in English written and spoken, fluency Dutch is appreciated
• Well-organized, decisive with a Quality mindset
• Travel – expected 15 % international travel time for onsite audits.
• Commitment and alignment to Pharming’s mission, core values and behaviors

Who We Are

We’re built on a simple belief: people living with rare diseases deserve more.

Pharming is a global biotechnology company taking on some of the toughest rare disease challenges. We develop and commercialise innovative therapies for rare and ultra-rare immunological and genetic diseases with significant unmet need, where our scientific and commercial expertise, long-term commitment, and real partnership can help advance care.

We put patients at the heart of our work. Their insights, along with those of caregivers, clinicians, scientists, and partners, shape our strategy, guide our decisions, and help turn science into meaningful progress. We keep it simple, act with urgency, and get it done — expanding access to approved therapies, advancing high-value pipeline programmes, and building a leading global rare disease company.

Our vision is simple: a world where people living with rare diseases don’t wait for progress or care. Together with the communities who inspire us, we’re opening new possibilities — proving that breakthroughs aren’t just discovered. They’re created together.

Ready to make a difference? Join us.

What It’s Like To Work Here

At Pharming, every role helps move rare disease therapies closer to the people who need them. We make it happen together, across teams, disciplines, and borders, because breakthroughs don’t happen in silos. Rare diseases are complex, and meaningful progress takes people who ask better questions, challenge each other, and turn insight into action. Here, you won’t work on the sidelines. Pharming is a place for builders, problem-solvers, and bold thinkers who move with urgency, take ownership, and stay focused on what matters most: improving the lives of people living with rare diseases. Advancing rare disease care isn’t the work of one team or one leader. It’s all of us, building what’s next together.

In Addition, We Offer

• Competitive year salary
• 8.33% holiday allowance
• A minimum of 30 vacation days for a healthy work-life balance
• Excellent pension plan to secure your future