Plant Quality Manager

About the role

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.

What you will do

• 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.

Qualifications

Education

• Bachelor's Degree in Chemistry, Pharmacy, Microbiology, Chemical Engineering, or similar. (Preferred)
• Advanced degree (Preferred)

Experience

• 4-6 years in FDA-regulated OTC, pharmaceutical, or personal care environments. (Preferred)
• 4-6 years managing FDA inspections and remediation efforts. (Preferred)
• 4-6 years background in aerosol manufacturing. (Preferred)
• 4-6 years background in topical formulations. (Preferred)

Skills and Abilities

• 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)

Licenses and Certifications

• ASQ Certification (Preferred)
• Lean Six Sigma or OpEx training (Preferred)