Quality Assurance Manager

Job Title:

Location:

Department:

Reports To:

Job Summary:

We are looking for a highly skilled and experienced Quality Assurance Manager to lead our QA function specializing in nutraceutical manufacturing, particularly in the area of herbal extracts. The ideal candidate will have a solid background in quality management systems, food-related certifications, and comprehensive experience in handling regulatory audits, including US FDA inspections. This role will be critical in ensuring that our herbal extract products meet the highest standards of safety, quality, and compliance with international regulations.

Key Responsibilities:

Leadership & Strategic Oversight:

• Lead the Quality Assurance department, overseeing quality systems, processes, and compliance for all herbal extract products.

• Develop, implement, and maintain QA strategies, policies, and procedures to ensure consistent product quality and regulatory compliance.

• Collaborate with cross-functional teams, including Production, R&D, and Supply Chain, to embed quality standards throughout the product lifecycle.

• Promote a culture of quality and continuous improvement across the organization.

Regulatory Compliance & Certifications:

• Ensure compliance with applicable regulatory standards, including US FDA, cGMP, and other local and international food and nutraceutical regulations.

• Lead and manage certification processes for NSF, ISO, HACCP, SQF, and other relevant certifications for herbal extract products.

• Ensure ongoing inspection readiness and act as the point of contact for US FDA and other regulatory bodies during audits and inspections.

Quality Management Systems (QMS):

• Implement and maintain an effective Quality Management System (QMS) to monitor and ensure the quality of herbal extract products.

• Oversee documentation control, ensuring all batch records, standard operating procedures (SOPs), and product specifications are accurate and up to date.

• Lead root cause analysis, corrective and preventive actions (CAPA), and continuous improvement initiatives to mitigate risks and enhance product quality.

Risk Management & Process Control:

• Establish robust quality control procedures for herbal extracts, including testing for purity, potency, and safety.

• Lead the development and execution of risk management strategies, focusing on critical control points in manufacturing processes.

• Manage non-conformance reports (NCRs) and implement corrective actions to prevent recurring quality issues.

Team Leadership & Development:

• Build, mentor, and develop a high-performing QA team, ensuring they are trained and capable of meeting quality and regulatory requirements.

• Set performance objectives, provide regular feedback, and foster professional growth within the QA team.

• Liaise with internal departments and external partners to ensure quality expectations and requirements are met.

Qualifications & Experience:

Education:

• Bachelor’s or Master’s degree in Food Science, Chemistry, Biology, or a related discipline. Advanced qualifications in herbal sciences or nutraceuticals is a plus.

Experience:

• 7+ years of progressive experience in quality assurance, with at least 5 years in a leadership role within the nutraceutical or food manufacturing industry, particularly focused on herbal extracts.

• Comprehensive experience with food safety certifications such as NSF, ISO 22000, HACCP, or SQF.

• Strong knowledge of cGMP, FDA regulations, and hands-on experience with US FDA audits and inspections.

• Familiarity with quality standards for herbal extracts, including testing for botanical identification, chemical profiling, and safety.

Skills:

• Proven expertise in quality systems management, regulatory compliance, and process improvement.

• Strong analytical skills with the ability to troubleshoot complex quality issues.

• Excellent leadership, communication, and project management skills.

• Proficiency in using QA software and quality management tools.

Preferred Qualifications:

• Specialized knowledge in herbal extract manufacturing and related quality standards.

• Previous experience with international regulations and certifications for herbal products.

• Six Sigma, Lean Manufacturing, or other continuous improvement certifications.

Compensation: