QA Compliance & Regulatory Affairs Leader

Multi-Pak Packaging; Caldwell (NJ); On-site; USD 110,000 - 170,000; Full time

Job summary

Truvant Health and Beauty is seeking a QA Compliance & Regulatory Affairs Manager to lead the Quality Management System and ensure FDA regulatory compliance across cGMP standards. The role oversees QA systems, training, deviations, CAPAs, audits, and supplier qualification to support new client onboarding and product launches.

Responsibilities include maintaining documentation practices, inspection readiness, and continuous improvement initiatives.

Qualifications

• Minimum 5 years in Nutritional Supplement, Vitamin, or OTC Drug industry.
• Bachelor's degree in a scientific discipline preferred.
• Hands-on experience supporting quality systems, deviations, CAPAs, audits, and regulatory compliance in GMP environments.
• PCQI and/or HACCP certification preferred.
• Excellent verbal and written communication skills.
• Advanced proficiency in Microsoft Excel and other Office applications.
• Detail-oriented with strong organizational skills and ability to manage multiple priorities.
• Experience supporting FDA, customer, third-party certification and regulatory audits.

Responsibilities

• Update and revise SOPs and enforce compliance with cGMPs.
• Support inspection readiness, KPI generation, and continuous improvements.
• Maintain quality system programs including Deviation, CAPA, and Change Control.
• Conduct internal and customer investigations with root-cause analysis.
• Oversee CAPA system focusing on timely actions and closure.
• Evaluate new client/product opportunities for regulatory requirements.
• Submit new/revised materials to certifying agencies as required.
• Identify compliance risks and propose corrective actions.
• Communicate with all departments to exchange accurate information.
• Manage site certifications registration/renewal/maintenance.
• Plan and conduct internal audits for regulatory and internal standards.
• Oversee FDA compliance programs for ongoing regulatory compliance and audits.
• Oversee QA Systems/Training to ensure documentation, records, and training.
• Plan supplier/vendor audits to assess quality and regulatory requirements.

Skills

FDA cGMP knowledge

PCQI/HACCP

Excel proficiency

Regulatory audits experience

Communication skills

Documentation control

Education

Bachelor's degree in science

Tools

Microsoft Office

Job description

Truvant Health and Beauty is seeking a QA Compliance & Regulatory Affairs Manager to lead the Quality Management System and ensure FDA regulatory compliance across cGMP standards. The role oversees QA systems, training, deviations, CAPAs, audits, and supplier qualification to support new client onboarding and product launches.

Responsibilities include maintaining documentation practices, inspection readiness, and continuous improvement initiatives.