Quality Manager

In this role, you will lead Quality Assurance, Quality Control Laboratories, Document Control, Validation, and Complaint Management operations, while overseeing the implementation and continuous improvement of the site Quality Management System in alignment with FDA requirements and corporate standards. You will serve as the site quality lead for FDA and customer inspections, ensuring a constant state of inspection readiness, addressing compliance issues, and managing CAPAs effectively.

The position promotes accountability, data integrity, and a right-first-time mindset, and collaborates closely with Operations, Engineering, R&D, and other cross-functional teams on investigations, change management, validations, and continuous improvement initiatives. Responsibilities include supervising batch record review, product release, deviations, and investigations; working directly with customers and stakeholders to meet compliance expectations; and analyzing quality metrics to drive performance and improvement.

You will coach and develop a high-performing quality organization, ensure appropriate resourcing, represent site quality leadership in executive meetings, contribute to alignment with corporate quality strategy, and participate in strategic planning and facility expansion discussions. Duties may vary slightly by location.

The ideal candidate holds a Bachelor"s degree in Chemistry, Pharmacy, Microbiology, Chemical Engineering, or a related discipline, with an advanced degree preferred, and brings more than 10 years of experience in FDA-regulated OTC, pharmaceutical, or personal care manufacturing environments. This experience includes extensive leadership of FDA inspections and remediation efforts, with additional exposure to aerosol manufacturing and topical formulations considered a strong plus.

The role requires expert-level proficiency in cGMPs, 21 CFR Parts 210/211, ICH, and USP requirements, as well as demonstrated success leading FDA and customer audits, maintaining inspection readiness, and developing and verifying effective remediation plans. Candidates must be adept at partnering with Operations, Engineering, and R&D on QMS initiatives, coaching and mentoring teams, and ensuring appropriate quality resourcing.

Strong internal and external stakeholder communication skills are essential, along with high proficiency in ERP systems such as SAP, quality platforms such as LIMS or MasterControl, and TrackWise. The successful candidate will have a proven ability to drive transformation in quality mindset and execution across the organization. ASQ certification and Lean Six Sigma or Operational Excellence training are preferred.