Aspen Global is seeking a strong QA leader to drive all aspects of our quality program, develop our QA/QC team and work closely with the executive leadership team to expand the vision and direction of the QA team as we continue to experience significant growth and navigate complex initiatives around our growth.
You will be highly motivated, self-driven, a team builder and a business partner. Understanding the complexities of balancing the ever changing regulatory environment in a dynamic business. Imperative to understand the value of delegation and team member development. QA must have a mind to support and work with the business units--not work in isolation.
Position Summary The Quality Assurance (QA) Manager leads the quality department, drives strategic quality initiatives, and successfully balances strict regulatory compliance with the commercial goals and growth timelines of the business.
Key Responsibilities
- Strategic Leadership: Drive the long-term vision for the quality department to support business growth and operational scaling.
- Team Management: Lead, mentor, and develop the daily operations of the QA/QC team.
- Commercial Alignment: Balance strict regulatory compliance with commercial needs, minimizing production bottlenecks and optimizing speed-to-market.
- Regulatory Compliance: Enforce cGMP compliance in strict accordance with FDA 21 CFR Part 111 regulations.
- Certification Management: Oversee and maintain NSF International dietary supplement certification requirements.
- Organic Compliance: Manage USDA Organic certification standards, including identity preservation and supply chain documentation.
- Audits and Inspections: Lead third-party (NSF, Organic certifying agencies), customer, and FDA regulatory plant inspections.
- Risk Management: Direct root-cause analysis for out-of-specification (OOS) results, deviations, and Corrective and Preventive Actions (CAPA).
Qualifications and Requirements
- Education: Bachelor’s degree in Chemistry, Biology, Food Science, or a related scientific field.
- Experience: 5+ years of QA/QC leadership in dietary supplement, nutritional, confectionary or pharmaceutical manufacturing.
- Business Acumen: Proven track record of aligning quality metrics with business objectives and commercial timelines.
- Certifications: Active certifications or direct experience handling NSF cGMP, Organic and OTC registry requirements.
- Skills: Expert knowledge of cGMP audits, organic handling plans, and cross-functional corporate strategy.
We are anxious to find the right leader to support our team as we continue to grow!