Estée Lauder Companies Director, Clinical Quality Assurance
Estée Lauder Companies seeks Director of Clinical QA in Melville, NY. Lead GCCS quality compliance, risk-based monitoring, and GxP management. $124K–$214K annually.
Role & Responsibilities
- Establish and implement quality standards for GCCS functions within Estée Lauder and at contract organizations conducting studies on behalf of the company
- Maintain and mature the risk-based monitoring program aligned with ICH E6(R3) principles, standardizing study risk assessment and classification to prioritize monitoring resources accordingly
- Implement, maintain, and lead continuous improvement of the R&D GxP Quality Management System, including development of quality metrics, review and enforcement of SOPs, and timely completion of deviations, change controls, investigations, and CAPA measures
- Define and implement the global Clinical QA strategy aligned with ICH GCP (E6 R2/R3), regulatory authority expectations, and enterprise quality objectives
- Review GxP-controlled documentation including SOPs, validation documentation (IQ/OQ/PQ), study documentation, reports, deviations, and CAPAs
- Proactively identify, assess, and escalate quality risks and compliance issues to senior management, including the VP of Corporate QA and Sr. VP of GCCS
- Serve as the primary Clinical QA representative on cross-functional project teams and governance forums, providing quality leadership and independent oversight
- Partner with R&D Product Integrity leadership, Regulatory Affairs, Legal, and Global Quality to resolve complex quality and compliance matters
- Review and approve clinical and non-clinical study reports to ensure alignment with approved protocols, accuracy and integrity of data, and compliance with ICH GCP and internal standards
- Partner with Global Quality Audit group to ensure initial and ongoing qualification of CROs and facilitate related corrective actions
- Represent GCCS in internal audits and regulatory inspections, ensuring timely completion of audit observations and inspection finding responses
- Conduct annual GCP training and ensure adequate training plans and documentation for new and existing staff
- Oversee document control and archiving processes and maintain awareness of current ICH GCP E6 trends and regulatory authority expectations
Qualifications
- Bachelor's degree in Life Sciences or a related scientific discipline
- Minimum 5 years' experience in a GCP-regulated clinical quality environment
- Demonstrated expertise of ICH GCP E6 and working knowledge of OTC regulatory requirements
- Proven leadership experience with the ability to influence senior stakeholders
- Strong analytical, problem-solving, organizational, and decision-making skills
- Ability to work independently, manage multiple priorities, and adapt to changing regulatory and business needs
Skills
Experience
Minimum 5 years in a GCP-regulated clinical quality environment, with demonstrated expertise in ICH GCP E6, risk-based monitoring program design, and clinical quality assurance. Proven ability to lead quality management initiatives, influence senior stakeholders on compliance matters, and manage multiple priorities in a regulated environment. Preferred experience includes compiling and trending risk-based monitoring outputs, overseeing global teams or external partners, and leveraging advanced analytics or AI-enabled tools for quality oversight.
Education
Bachelor's degree in Life Sciences or a related scientific discipline.
Workplace
This position is based in Melville, New York, USA, within easy reach of New York.
Compensation
The base compensation for this position ranges from USD 124,200 to USD 214,000 per annum.
Benefits
Health insurance coverage (medical, dental, and vision insurance), wellness and family support programs, life and disability insurance, retirement savings plans, paid leave programs, education-related programs, paid holidays and vacation time, highly competitive bonus program with possibility for overachievement based on performance and company results, share incentive plan participation.
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Frequently Asked Questions
The luxury industry is characterised by a diverse and nuanced nomenclature. Esteemed houses frequently employ proprietary terminology, and even within a single organisation like Estée Lauder Companies, titles may vary across global markets to reflect local conventions. To ensure absolute clarity, Cerulean assigns a standardised, industry-coherent canonical title to every listing. However, it is worth noting that this role is functionally synonymous with «Director of Clinical QA», «Clinical Quality Assurance Director», «Head of Clinical Quality», «Clinical Compliance Director», and other variations. Our sophisticated search architecture anticipates these variations, ensuring that inquiries using related terms will seamlessly yield the exact roles you desire.