Director of Global Innovation Quality Compliance Clinical

Director, Clinical QA

The Estée Lauder Companies Inc. is one of the world's leading manufacturers, marketers, and sellers of quality skin care, makeup, fragrance, and hair care products, and is a steward of luxury and prestige brands globally. The company's products are sold in approximately 150 countries and territories under brand names including:
Estée Lauder, Aramis, Clinique, Lab Series, Origins, M
· A·C, La Mer, Bobbi Brown Cosmetics, Aveda, Jo Malone London, Bumble and bumble, Darphin Paris, TOM FORD, Smashbox, AERIN Beauty, Le Labo, Editions de Parfums Frédéric Malle, GLAMGLOW, KILIAN PARIS, Too Faced, Dr.Jart+, the DECIEM family of brands, including The Ordinary and NIOD, and BALMAIN Beauty.

As the Director, Clinical QA, you are responsible for establishing and implementing standards for execution in GCCS (Global Clinical and Consumer Sciences) functions both within the Estee Lauder companies and at contract organizations conducting studies on behalf of Estee Lauder. Promotes a positive working environment by communicating clear directions on the quality strategy. Implement, maintain and lead continuous improvement of the R&D GxP Quality Management System including development and maintenance of quality metrics, review/approval/enforcement of SOPs, timely completion of deviations, change controls, investigations, and implementation of CAPA measures, etc.

Oversee related document control/archiving processes. Maintains awareness of current ICH GCP E6 trends and regulatory authority expectations and implements improvements to the R&D QMS accordingly. Responsible for informing management of quality issues in a timely manner. Exhibit professionalism and foster teamwork to create an environment of support that leads to productivity of R&D personnel and ensures GxP compliance.

Provide Strategic Leadership for Clinical & Product Integrity Quality (50%)

• Maintain and continuously mature the RBM Program as part of a broader risk‑based quality management (RBQM) approach aligned with ICH E6(R3) principles of "quality by design" and risk‑proportionate oversight

• Standardize and govern study risk assessment and classification (e.g., High/Moderate/Low) and ensure monitoring resources are prioritized based on risk and need

• Ensure monitoring is planned and executed across defined program phases (e.g., pre‑study/study initiation, in‑life, post‑study/close‑out) in accordance with applicable SOPs and monitoring plans

• Drive monitoring focus on critical processes and critical data to protect panelists and ensure reliable results (e.g., informed consent/eligibility where applicable, data integrity expectations, deviation/CAPA signals, test product accountability, training/qualification evidence, and study file completeness)

• Define and implement the global Clinical QA strategy aligned with ICH GCP (E6 R2/R3), regulatory authority expectations, and enterprise quality objectives

• Ensure consistent application of quality by design and data integrity principles across R&D programs and lifecycle stages

• Review GxP controlled documentation including SOPs, FFU (Fit for Use) 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, as appropriate

• Maintain expert awareness of evolving global GCP trends, regulatory inspection findings, and industry best practices, translating them into actionable system improvements

Influence and Partner Across R&D to Embed a Culture of Quality (Strategic Influence – 40%)

• Serve as the primary Clinical QA representative on cross functional project teams and governance forums, providing quality leadership and independent oversight

• Influence R&D development strategies to enable compliant innovation, timely execution, and scientifically sound decision making

• Partner closely with R&D Product Integrity leadership, Regulatory Affairs, Legal, and Global Quality to resolve complex quality and compliance matters

• Provide expert guidance on change management, protocol deviation management, investigations,…