The Estée Lauder Companies attracts the most outstanding people from diverse industries and nurtures their talents. Whether they work in one of our stores, on a production line, at our corporate headquarters in New York City or in one of our affiliates worldwide, our employees take pride in their contributions to our success.
The Estee Lauder Companies Director, Global R&D Data Integrity in Melville, New York
Director, Global R&D Data Integrity
Brand: Estée Lauder Companies
The primary role of this position is to effectively lead the Data Integrity (DI) Governance globally across the R&D Sites. The individual is required to closely collaborate with Corporate functions – R&D, Supply Chain, IT and QA – to ensure robust DI processes are in place for an effective landscape.
The process scope includes
Leading the standardization of Process Documentation and SOPs across R&D in close collaboration with QA.
Managing governance of process, access, SOPs and documentation to ensure compliance.
Representing R&D on the Global Data Integrity Core Team for R&D DI execution activities.
Co-ordinating with the R&D Site Lab System Admin(s) to ensure robust operationalization & Implementation of DI policies, standards and guidelines.
The geographic scope is Global and includes all R&D Laboratories at Melville (USA), Blaine (USA), Shanghai (China), Toronto (Canada), Paris (France), Seoul (South Korea) and Tokyo (Japan).
- Leading the corporate R&D Data Integrity objectives
a. Establishing Process and SOP documentation standards in coordination with QA
b. Governance with R&D Site DI Leads and QA to conduct periodic verification of SOPs to ensure they are current and effective
c. Coordinate with R&D Lab System Admin for verification of system user access.
d. Ensure all GXP applicable systems have CSV (Computer System Validation) documentation and procedures in place
Managing the rollout DI requirements with R&D Site DI Leads, ensuring strong execution and stable implementation
Collaborating with Corporate functions – Global Supply Chain, Global QA and IT – to ensure robust Standard Operating Procedures and Work Instructions are in place to ensure compliance.
Provide management updates (monthly/quarterly) at Global and Site level to ensure visibility of priorities and risks for DI related activities.
Ensures adherence to FDA Validation, CFR 21 Part 11 and Change Control management processes requiring a detail knowledge of the R&D Quality Systems inclusive of Change Control , CAPAs and Deviation procedures.
●Experience in staff management with proven ability to manage and collaborate in a multi-location, multi-vendor environment with an emphasis on process documentation and training.
●Experienced in R&D processes and systems in a Fortune 500 CPG company in a highly dynamic corporate landscape across multiple brands
●Experienced in managing lab systems, SOPS and Work Instructions and other Quality System Documents.
●Knowledge of GXP (Good Clinical/Manufacturing/Documentation practices)
●Knowledge of FDA Validation and CFR 21 Part 11
●Knowledge of PLM applications and SAP ERP a plus
-Minimum 10 years experience
-10% travel time
Job: Research & Development
Primary Location: Americas-US-NY-Melville
Job Type: Standard
Shift: 1st (Day) Shift
Travel: Yes, 10 % of the Time
Job Number: 1924340
We are an equal opportunity employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply. 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 USApplicantAccommodations@Estee.com