Director of Global Innovation Quality Compliance Clinical

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 riskbased quality management (RBQM) approach aligned with ICH E6(R3) principles of quality by design and riskproportionate 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. prestudy/study initiation inlife poststudy/closeout) 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 nonclinical 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

Bachelors 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 riskbased 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 AIenabled tools to enhance quality oversight monitoring and data review activities
Experience overseeing global teams or external partners.