Estée Lauder Companies

Lead, Data Integrity Site Lead

Posted on: 5 Feb 2021

Bristol, PA

Job Description

The primary role of this position is to effectively lead the data integrity program across supply chain function (Mfg/QA) at the respective site/campus. This role is responsible for supporting the design of the corporate data integrity system as well as oversight across all GxP computerized systems. This role works closely the Global Data Integrity Technical Program lead to align on DI strategy for site/campus Data Integrity execution activities. The role works across multiple business functions at the site level to rollout Data Integrity requirements and ensuring excellence in execution with the technical community of the Supply Chain. This role provides visibility and management of priorities and risks and opportunities for Data Integrity related activities and elevated to leadership where appropriate. This role will assume direct responsibility for Data Integrity technical deliverables for Supply chain for their respective site with monthly updates.

Leads Data Integrity Rollout strategy at the respective site
Directs the efficient and effective execution of Data Integrity requirements across the site/campus
Liaisons with relevant cross-functional team ( DI Site program managers globally, mfg sites, R&D, IT, other) to coordination DI activities to leverage scale and maximize efficiencies accordingly.
Collaborates with other DI site program managers to share best practices and harmonized processes across the global mfg sites
Initiates and manages any DI work processes required for assigned program ( including Change Management) to ensure site is compliant
Resolves timeline issues related to executional deliverables and develops tactical plans when necessary to bring back on track.
Ensures Day to Day discipline to project plan and call out any risk of timeline gaps
Ensures implementation of continuous improvement and process improvements programs
Responsible to establish current state and work to drive remediation efforts and sustainable solutions
Responsible for managing the DI compliance on all GxP Computerized Systems Instruments and Equipment
Individual is responsible for technical management of all GxP computerized systems used at the respective site. This responsibility would include working with individual scientific, manufacturing system vendors, and drafting and maintaining current compliant system documentation, compliant training procedures and documentation, etc. This responsibility also requires developing and documenting the processes for the Equipment/Instrument management role.
Provide leadership to ensure that all initiatives are appropriately and effectively managed, documented and monitored for optimum efficiency and effective roll out.
Coordinate all future system rollouts, scientific applications and new system upgrades
Coordinate with Plant Operations team and site QA to conduct periodic, hands-on audits and an annual physical inventory verification of computerized systems throughout the site to ensure that systems are current and continue to function appropriately for current usage in Est e Lauder
Coordinate, execute and document all System User Verification for data integrity and compliance requirements.
Ensure all GXP applicable systems have CSV (Computer System Validation) documentation and procedures in place
Ensure all computerized systems have appropriate back up procedures
Corporate IT has procedure are in-place for IT managed systems
Site-wide stand-alone computerized system backup procedures are in-place and periodically tested for non-networked systems.
Works closely with the business stakeholders on business requirements, manages technical feasibility analysis, and financial analysis of proposed process and technical solutions.
Leads and manages the effective execution and implementation of computerized projects across the entire site including QA labs
Ensure production releases meet business expectations and adhere to standards.
Strong knowledge of Program Management, Project Management, Supply Chain processes
Effective communication with business stakeholders and project stakeholders.
Ensures adherence to System Development and Life cycle (SDLC), FDA Validation, CFR 21 Part 11 and Change Control management processes requiring a detail knowledge of the Quality Systems inclusive of Change Control, CAPAs and Deviation procedures.

Qualifications
-Bachelor's degree

-10% travel time

Additional Job Specifications:
Minimum of 5 years of relevant experience
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.
Must be an excellent team player with strong analytical skills, negotiating and communication skills
Strong program management skills including follow-up and organizational skills required
Ability to use computer systems necessary to meet objectives including Microsoft Office, MS project, SAP
Experienced in Supply Chain processes and systems in a Fortune 500 CPG company.
Experienced in managing various laboratory equipment and systems in a highly dynamic corporate landscape
Experienced in writing 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 Various software applications and SAP ERP a plus
Knowledge in Data Infrastructure/Security background is plus as well as any data Integrity & integration experience.
Modern HTML 5 and CSS skills e.g. responsive design
Competent in OO programming languages, specifically Java
Experience with Version Control technologies, ideally Git
SQL based languages (MySQL, MSSQL)
An understanding of Restful API concepts
Knowledge of JavaScript frameworks - Angular, JQuery and React
Understanding of Unix based systems, Terminal commands
Understands concepts of containers, e.g. Docker
Key concepts behind NoSQL databases.
IOS development skills
Cloud principles

Job: Information Technology
Primary Location: Americas-US-PA-Bristol
Job Type: Standard
Schedule: Full-time
Shift: 1st (Day) Shift
Job Number: 211096

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.

Estée Lauder Companies

New York, New York

The Estée Lauder Companies Inc. manufactures and markets skin care, makeup, fragrance, and hair care products. The company offers a range of skin care products, such as moisturizers, serums, cleansers, toners, body care products, exfoliators, acne care products, facial masks, cleansing devices, and sun care products; and makeup products, including lipsticks, lip glosses, mascaras, foundations, eyeshadows, nail polishes, and powders, as well as related items, including compacts, brushes, and other makeup tools. It also provides fragrance products in various forms comprising eau de parfum sprays and colognes, lotions, powders, creams, candles, and soaps; and hair care products consisting of shampoos, conditioners, styling products, treatment, finishing sprays, and hair color products, as well as sells ancillary products and services.

The company offers its products under the brand names of Estée Lauder, Aramis, Clinique, Prescriptives, Lab Series, Origins, M·A·C, Bobbi Brown, La Mer, Aveda, Jo Malone London, Bumble and bumble, Darphin, Ojon, Smashbox, RODIN olio lusso, FLIRT!, Le Labo, Editions de Parfums Frédéric Malle, GLAMGLOW, By Kilian, BECCA, and Too Faced. In addition, it operates as a licensee for fragrances and/or cosmetics sold under the Tommy Hilfiger, Donna Karan New York, DKNY, Kiton, Michael Kors, Tom Ford, Dr. Andrew Weil, Ermenegildo Zegna, AERIN, and Tory Burch brand names.

The company sells its products through department stores, specialty multi-brand retailers, upscale perfumeries, pharmacies, and salons and spas; freestanding stores; e-commerce Websites; stores in airports and on cruise ships; in-flight and duty-free shops; and self-select outlets. It has operations in the Americas, Europe, the Middle East, Africa, and the Asia Pacific. The Estée Lauder Companies Inc. was founded in 1946 and is based in New York, New York.

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