QUALITY MANAGER

FRAGRANCE MANUFACTURING INC•Allentown, PA

48d

About The Position

At FMI, our purpose is to Inspire Full Potential in our team, our clients and our community. We are a leading contract manufacturer of prestige beauty, personal care, and OTC products, partnering with some of the world's most recognized brands. Our success is built on operational excellence, innovation, customer focus, and a commitment to continuous improvement. FMI is seeking an experienced and results-driven Quality Manager to lead our Quality organization and ensure that customer expectations, regulatory requirements, and internal quality standards are consistently met or exceeded. This role is responsible for overseeing all aspects of the Quality Management System (QMS), including quality assurance, quality control, customer quality, compliance, audits, CAPA management, and continuous improvement initiatives. The ideal candidate will be a hands-on leader with extensive experience in regulated manufacturing environments, a strong track record of developing high-performing teams, and a passion for driving quality excellence through scalable systems and data-driven decision making.

Requirements

Bachelor’s degree in science, Engineering, Microbiology, Chemistry or related field required.
Minimum of 8 years of progressive quality leadership experience within a manufacturing environment.
Proven experience successfully managing a Quality team of at least 8 employees.
Demonstrated success implementing measurable quality improvements and cost-saving initiatives.
Demonstrated track record of increasing responsibility and measurable business impact.
Strong knowledge of FDA regulations, cGMP requirements, quality systems, audits, CAPA processes, and compliance programs.
Experience with ERP systems and quality-related data analysis.
Intermediate proficiency with Microsoft Office Suite, including Excel, Word, and Outlook.
Strong analytical, problem-solving, and decision-making capabilities.
Experience utilizing Statistical Process Control (SPC) and data-driven quality methodologies.
Lean Manufacturing and/or Six Sigma certification.
ASQ certifications or other quality-related professional certifications.
Evidence of continuous learning and professional development.

Nice To Haves

Experience within the cosmetics, personal care, fragrance, pharmaceutical, or OTC manufacturing industry preferred.

Responsibilities

Lead and develop the Quality team, including supervisors, technicians, and quality professionals, while fostering a culture of accountability, engagement, and continuous improvement.
Maintain and continuously improve FMI's Quality Management System to ensure compliance with FDA, cGMP, OTC, customer, and industry requirements.
Oversee customer complaints, investigations, corrective actions, and quality communications to ensure timely and effective resolution.
Lead internal audits, customer audits, regulatory inspections, and supplier quality activities while maintaining a state of audit readiness.
Drive continuous improvement initiatives utilizing root cause analysis, CAPA processes, Statistical Process Control (SPC), Lean Manufacturing, and Six Sigma methodologies.
Establish, monitor, and improve key quality performance indicators, including First Time Quality, customer complaint trends, audit performance, CAPA effectiveness, training compliance, and cost of quality.
Partner closely with Operations, Product Development, Supply Chain, Planning, and Customer Experience teams to ensure product quality and customer satisfaction.
Ensure product specifications, procedures, and quality documentation are accurate, compliant, and maintained in a timely manner.
Develop and execute employee training and development programs to strengthen technical capabilities and leadership within the Quality organization.
Manage departmental budgets, quality-related expenditures, and initiatives focused on reducing quality costs while maintaining compliance and product excellence.
Serve as a key contributor to operational excellence initiatives that improve efficiency, reduce waste, and enhance overall business performance.