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
o Standardize and govern study risk assessment and classification (e.g., High/Moderate/Low) and ensure monitoring resources are prioritized based on risk and need
o 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
o 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, and CAPA effectiveness.
- Drive adoption of risk based decision making and accountability across R&D by modeling enterprise leadership behaviors and influencing without authority.
Oversee Auditing, Monitoring, and External Partner Compliance (Oversight & Readiness – 10%)
- Review and approve clinical and non‑clinical study reports (e.g., Claims, Tolerance in Claims, Consumer Sciences) to ensure alignment with approved protocols, accuracy and integrity of data, appropriateness of statistical analyses, and compliance with ICH GCP, internal SOPs, and data integrity standards prior to final approval and use.
- Partner with Global Quality Audit group to ensure initial and ongoing qualification of CROs.
- Facilitates related corrective actions.
- Represent GCCS (Global Clinical and Consumer Sciences) in internal audits and/or regulatory inspections.
- Ensure responses to audit observations/inspection findings (internal and external) are completed in a satisfactory and timely manner.
- Conduct annual GCP training.
- Ensure adequate training plans and documentation for new and existing staff.
- Approximately 5% domestic and/or international travel
- 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.
Preferred:
- Experience compiling and trending risk‑based monitoring outputs (e.g., monitoring findings, risk indicators, deviation trends) to support risk classification, monitoring strategy adjustments, and escalation decisions. Synthesizing and trending quality and compliance data to provide actionable insights for senior leadership and to guide quality oversight strategies.
- Knowledge of leveraging advanced analytics, automation, or AI‑enabled tools to enhance quality oversight, monitoring, and data review activities
- Experience overseeing global teams or external partners.
Pay Range:
The anticipated base salary range for this position is $124,200.00 to $214,000.00. Exact salary depends on several factors such as experience, skills, education, and budget. Salary range may vary based on geographic location. In addition to base salary, this position is eligible for participation in a highly competitive bonus program as well as participation in the share incentive plan. In addition,
In addition to base salary, this position is eligible for participation in a highly competitive bonus program with the possibility for overachievement based on performance and company results. In addition, The Estée Lauder Companies offers a variety of benefits to eligible employees, including 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, and many others. Many of these benefits are subsidized or fully paid for by the company.
Equal Opportunity Employer
It is Company's policy not to discriminate against any employee or applicant for employment on the basis of race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. The Company will endeavor to provide a reasonable accommodation consistent with the law to otherwise qualified employees and prospective employees with a disability and to employees and prospective employees with needs related to their religious observance or practices. Should you wish to apply for this position or any other position with the Company and you believe you require assistance to complete an application or participate in an interview, please contact [email protected].
Michigan Applicants: Persons with disabilities needing accommodations for employment must notify the company in writing of the need for an accommodation within 182 days after the date the person with a disability knew or reasonably should have known that an accommodation was needed.
Philadelphia Applicants: Philadelphia's Fair Chance Hiring Law
Rhode Island Applicants: The company is subject to chapters 29-38 of title 28 of the general laws of Rhode Island and is therefore covered by the state's workers' compensation law.
