Manager, Quality Assurance

About the Role

Oversee the day-to-day operations of the Quality Assurance Department, including internal and external audits, document control, compliance, GMP training, SOP development and control, and other related programs. Identify continuous improvement activities to enhance and sustain GMP compliance in the production of Dietary Supplements and other IVC products.

Responsibilities

• Enforce GMP compliance in the organization and with strategic partners.
• Review and assist in developing quality system policies and procedures.
• Maintain and implement the company’s quality system policies and procedures.
• Develop, update, and maintain the company’s standard operating procedures (SOPs).
• Participate in or lead external audits and coordinate functional groups with the development of their corrective and preventive action (CAPA) responses; prepare audit reports and monitor sustainability of identified CAPAs.
• Prepare quality reports and conduct monthly meetings with the operations group to discuss quality issues and improvements.
• Oversee the GMP squad and collaborate with all functional departments to ensure program effectiveness.
• Perform additional tasks or special projects as assigned by senior Quality Management.
• Ensure regular attendance to perform essential job functions within assigned work hours.
• Perform individual assignments as directed by management.

Requirements

• Bachelor’s degree in a related field or equivalent job experience.
• 2–5 years of experience in quality assurance or a related role.
• Minimum 5–10 years of experience establishing and maintaining quality systems in the Dietary Supplements and/or pharmaceutical manufacturing industry, with 3+ years in a supervisory role.

Skills

• Computer literate with proficiency in Microsoft Office (Word, Excel, Access, PowerPoint).
• Knowledge of 21 CFR 110 and 111 quality regulations and current Good Manufacturing Practices (cGMP) guidelines.
• Ability to work in a manufacturing environment with airborne powder, noise, and moving equipment.
• Strong communication skills; ability to read, write, and understand English.
• Ability to sit, walk, stand, and reach frequently.