Quality & Compliance Manager

Company Overview

Pure Source, Inc. is a leading private label and contract manufacturing company specializing in pharmaceuticals, cosmetics, vitamins, and supplements. Operating from a state-of-the-art facility since 1995, we are committed to quality, safety, and organic certification to deliver the purest products for our clients.

Position Summary

We are seeking an experienced Quality & Compliance Manager to lead and oversee all aspects of

quality assurance within a contract manufacturing environment. This role ensures compliance with

regulatory standards, maintains robust quality management systems, and drives continuous

improvement to support product quality and operational excellence. The ideal candidate will bring

strong technical expertise and leadership skills to manage quality systems for cosmetics and OTC drug

products.

Essential Duties and Responsibilities

• Develop, implement, and maintain risk-management strategies within the Quality Management

System (QMS), including deviations, complaints, change control, CAPA, APQR, OOS, training,

document control, and internal audits.

• Ensure compliance with GMP, FDA regulations (21 CFR Parts 210/211), and ISO 22716.

• Support root-cause investigations and CAPA activities for non-conformances, complaints, and

deviations.

• Review and approve quality investigations, CAPAs, change controls, validation protocols, and APQR

reports.

• Design, implement, and improve QMS processes in accordance with FDA, ISO, and GMP standards.

• Lead cross-functional initiatives to enhance quality systems and operational performance.

• Develop, write, review, and implement SOPs for quality functions.

• Manage QC data analysis, trending, and reporting of key quality metrics.

• Oversee internal audit programs and maintain readiness for regulatory and customer inspections.

• Train, mentor, and develop QA staff and cross-functional teams.

• Set team goals, provide direction, and conduct formal performance reviews.

Qualifications

• Minimum 7 years of QA experience in a regulated manufacturing environment (cosmetics or OTC

required).

• Bachelor's degree in a scientific or technical field (Chemistry, Biology, Pharmaceutical Sciences, etc.).

Preferred Skills & Experience

• Expertise in compliance remediation within FDA-regulated industries.

• Strong knowledge of 21 CFR Parts 11, 210, 211, GMP, ISO 22716, and data integrity principles.

• Experience working with cross-functional teams and enterprise systems.

• Excellent problem-solving skills and attention to detail.

• Strong communication and organizational skills.

• Proficiency in Microsoft Office and experience with electronic QMS platforms.

Additional Responsibilities

• Oversee and maintain company quality systems to ensure ongoing compliance.

• Lead, train, and develop QA staff while nurturing a culture of continuous improvement.

• Participate in management meetings to align quality initiatives with business goals.

• Host and support FDA inspections, GMP audits, and customer assessments.

• Review and approve batch records, deviations, CAPAs, change controls, and validation protocols.

• Manage product and raw material specifications.

• Conduct internal quality audits and ensure timely completion of corrective actions.

• Manage customer complaints and ensure effective resolution.

• Support international documentation and registration activities.

• Collaborate across teams to ensure consistent quality throughout production and packaging.

• Recommend and implement CAPAs to maintain compliance and product quality.

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Relocation assistance
• Vision insurance

Work Location: In person