Manager, Plant Quality

Voyant Beauty•Holmdel Township, NJ

About The Position

The Plant Quality Manager provides strategic and operational leadership for all quality functions at a high-volume OTC manufacturing facility. This role ensures GMP compliance, drives a quality culture, and leads quality system improvements to enhance overall site performance. As a critical leader, the Plant Quality Manager will strengthen the Quality organization, foster quality culture transformation, and optimize operational excellence across the facility. The ideal candidate is a hands-on, technically proficient leader with cGMP knowledge (21 CFR 210/211) and the ability to align cross-functional teams to elevate the site's quality systems and compliance.

Requirements

10+ years in FDA-regulated OTC, pharmaceutical, or personal care environments.
10+ years managing FDA inspections and remediation efforts.
Expertise in cGMPs, 21 CFR 210/211, ICH, USP (High proficiency)
Leading FDA/customer audits and inspection readiness (High proficiency)
Remediation planning and effectiveness verification (High proficiency)
Working with Ops, Eng, and R&D on QMS topics (High proficiency)
Team coaching, mentoring, and resourcing (High proficiency)
Effective internal/external stakeholder communication (High proficiency)
ERP (e.g., SAP), LIMS (e.g., MasterControl), TrackWise (High proficiency)
Driving transformation in quality mindset and execution (High proficiency)
Bachelor's Degree in Chemistry, Pharmacy, Microbiology, Chemical Engineering, or similar.

Nice To Haves

advanced degree
10+ years background in aerosol manufacturing and topical formulations is a plus.
ASQ Certification
Lean Six Sigma or OpEx training

Responsibilities

Lead QA, QC Labs, Document Control, Validation, and Complaint Management operations.
Oversee implementation and improvement of site QMS in line with FDA and corporate standards.
Serve as quality site lead for FDA and customer inspections. Ensures inspection readiness at all times.
Address compliance issues and manage CAPAs effectively.
Promote accountability, data integrity, and a right-first-time mindset.
Collaborate with Ops, Eng, R&D, etc., on investigations, change management, validations, and continuous improvement.
Supervise review of batch records, product release, deviations, and investigations.
Work with customers, and other stakeholders to meet compliance expectations.
Analyze metrics to drive performance and quality improvement.
Coach and develop a High Performing Team. Ensure effective resourcing of quality teams.
Represent site quality leadership in executive meetings.
Contribute to corporate quality strategy alignment.
Participate in strategic planning and facility expansion discussions.
Some duties may vary slightly by location.