Validation Manager

We are one of the world’s leading manufacturers, marketers, and sellers of quality skin care, makeup, fragrance, and hair care products, and a steward of luxury and prestige brands globally. Our 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.

About the role

The Validation Manager is responsible for leading the site's validation program to ensure manufacturing processes, equipment, facilities, utilities, computerized systems, and quality systems comply with applicable cGMP regulations, validation requirements, and industry standards. This role provides strategic leadership and technical expertise in the development, implementation, and continuous improvement of validation processes across the Melville site while ensuring inspection readiness and regulatory compliance. The Validation Manager partners with Quality, Engineering, Manufacturing, Facilities, and other cross-functional teams to maintain a robust validation program that supports operational excellence, product quality, and successful regulatory inspections.

Responsibilities

• Validation Compliance & Oversight (40%)
  • Lead the development, implementation, and continuous improvement of the site's validation program to ensure compliance with applicable cGMP regulations, validation requirements, and industry best practices.
  • Partner with the GMP Site Director to establish validation strategies and ensure validation activities effectively support manufacturing operations, facilities, utilities, equipment, and computerized systems.
  • Provide technical leadership and subject matter expertise on validation principles and regulatory expectations across the site.
  • Provide oversight to cross-functional teams to ensure compliance with documented validation policies, procedures, and regulatory requirements.
  • Oversee validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Process Performance Qualification (PPQ), cleaning validation, change control assessments, and validation-related deviations.
  • Ensure validation documentation is accurate, complete, and maintained in accordance with company procedures and regulatory expectations.
  • Monitor validation performance and identify opportunities to strengthen compliance, improve processes, and reduce operational risk.
  • Liaise with site functions such as manufacturing, planning, QA, QC, and operations.
• Regulatory Compliance (20%)
  • Maintain expert knowledge of applicable FDA regulations, cGMP requirements, validation guidance, and industry standards to ensure ongoing regulatory compliance.
  • Interpret evolving regulatory requirements and translate them into practical, sustainable solutions for site implementation.
  • Ensure validation practices remain aligned with current regulatory expectations and industry best practices.
• Inspection Readiness (20%)
  • Support regulatory inspections, customer audits, and internal quality audits by serving as the site's validation subject matter expert.
  • Prepare validation documentation, respond to regulatory inquiries, and support the timely resolution of audit observations and compliance actions.
  • Promote a continuous state of inspection readiness across all validation-related activities.
• Training & Continuous Improvement (10%)
  • Partner with functional leaders to ensure validation-related training programs remain current and effectively support employee compliance with validation and cGMP requirements.
  • Identify opportunities to improve validation systems, documentation practices, and operational processes through continuous improvement initiatives.
  • Foster a culture of quality, compliance, and operational excellence throughout the organization.
• Collaboration & Best Practice Sharing (10%)
  • Collaborate with Quality and Manufacturing teams across multiple sites to share best practices, standardize validation approaches, and drive continuous improvement initiatives.
  • Support corporate quality initiatives and contribute to the development and implementation of enterprise-wide validation standards.

Requirements

• BS in Engineering or relevant work experience.
• 5+ years of experience in FDA-regulated industries (Medical Devices or Pharmaceutical).
• Strong oral and written communication and presentation skills.
• Experience in writing and executing protocols including complex systems such as Process Validation, cleaning validation, utilities, manufacturing equipment (e.g., computer-controlled filling systems, formulation systems).
• Ability to manage complex projects and timelines in a matrix team environment.
• Strong project management and organizational skills.
• Demonstrated interpersonal skills including strong negotiation and facilitation skills.
• Proficiency in cGMP & Regulatory Compliance.
• Strong risk assessment and problem-solving abilities.

Pay

Anticipated Base Salary Range: $85,000.00 to $132,650.00 (depending on qualifications, skills, experience, and/or budget), based on a 40-hour work week (range to be scaled accordingly).

Benefits

• Health insurance coverage (medical, dental, and vision insurance).
• Wellness and family support programs.
• Life and disability insurance.
• Retirement savings plans.
• Education-related programs.
• Paid holidays and vacation time.
• Highly competitive incentive compensation programs (role eligibility may vary based on terms of the respective plan(s)).
• Eligibility to participate in the applicable Commission/Bonus Plan, under the plan guidelines in effect at the time of hire.