Senior Manager CQA (Leiden, NL)

ph3The role: /h3 pThe 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). /p pThe 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. /p h3Areas of responsibility: /h3 h3People leadership and team performance /h3 ul liLead, coach and develop the CQA team; establish clear objectives, roles, priorities and decision rights. /li liEnsure team members are appropriately qualified and trained, with individual development plans and succession considerations. /li liCreate an inclusive, psychologically safe and high-performing environment in which workload, wellbeing, accountability and delivery are actively managed. /li liMonitor capacity, timelines and performance indicators; escalte resource or delivery risks in a timely manner. /li /ul h3Clinical and pharmacovigilance quality oversight /h3 ul liProvide independent GCP and GVP oversight for clinical development and pharmacovigilance activities, including oversight of outsourced activities. /li liOwn or oversee the review, approval and lifecycle management of clinical and pharmacovigilance quality-system documents, standards and procedures. /li liAdvise study teams on quality-by-design, critical-to-quality factors and proportionate, risk-based controls throughout study planning, conduct and close-out. /li liOversee the quality and integrity of trial documentation, including risk-based reviews of the electronic Trial Master File (eTMF) and related systems. /li /ul h3Quality risk, issues and continuous improvement /h3 ul liFacilitate and challenge quality risk assessments; ensure significant risks are visible, owned, mitigated and monitored. /li liIdentify trends and systemic issues using quality metrics, audit outcomes and inspection intelligence; sponsor sustainable improvement actions. /li liAssess the impact of new or revised regulations, guidelines and industry expectations and coordinate timely implementation within the quality system. /li /ul h3Audit, vendor oversight and inspection readiness /h3 ul liDevelop and maintain a risk-based audit program covering investigator sites, CROs, safety vendors, laboratories and other GxP service providers. /li liLead or oversee GCP, GVP and relevant GLP audits; communicate findings clearly and ensure timely, risk-appropriate remediation and closure. /li liMaintain 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. /li /ul h3Stakeholder partnership and governance /h3 ul liServe as the primary CQA point of contact and trusted advisor for Clinical Development and operations, Pharmacovigilance, Regulatory Affairs and other relevant functions. /li liParticipate in cross-functional projects, providing independent quality judgement and escalating significant compliance or patient-safety concerns. /li liBuild effective quality relationships with external partners and suppliers; define expectations, performance measures and escalation pathways in quality agreements. /li liPrepare concise quality updates, risk summaries and management reports for senior stakeholders and quality governance bodies. /li /ul h3Your profile: /h3 h3Qualifications experience: /h3 ul liMaster’s degree in life sciences, pharmacy, medicine or a related discipline, or a bachelor’s degree with substantial relevant experience. /li liAt 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. /li liStrong 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. /li liDemonstrated experience leading people, projects; direct line-management experience is strongly preferred. /li liProven experience planning and conducting GCP/GVP audits and supporting or leading regulatory inspections. Lead-auditor training is an advantage. /li liExperience with electronic quality-management systems and eTMF platforms. /li liExplains quality expectations clearly, manages challenging conversations. Can be both persistent and flexible to adapt in a new situation. /li liLanguage requirements: Fluent in English written and spoken, fluency Dutch is appreciated. /li liWell-organized, decisive with a Quality mindset. /li liTravel – expected 15 % international travel time for onsite audits. /li liCommitment and alignment to Pharming’s mission, core values and behaviors. /li /ul h3Who we are /h3 pWe’re built on a simple belief: people living with rare diseases deserve more. /p pPharming is a global biotechnology company taking on some of the toughest rare disease challenges. We develop and commercialize 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. /p pWe 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 programs, and building a leading global rare disease company. /p pOur 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. /p pReady to make a difference? Join us. /p h3What it’s like to work here /h3 pAt 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. /p pIn addition, we offer: /p ul liCompetitive year salary /li li8.33% holiday allowance /li liA minimum of 30 vacation days for a healthy work-life balance /li liExcellent pension plan to secure your future /li /ul /p #J-18808-Ljbffr