Quality Assurance Manager

Company Information:  Vantage Hemp operates a state-of-the-art hemp extraction facility in Greeley, Colorado, producing pharmaceutical-grade CBD and finished goods. Its cGMP-certified CBD Isolate and Distillate APIs are FDA-registered, TGA-certified, and meet European Pharmacopoeia standards. Adhering to global pharmaceutical regulations, including FDA 21 CFR 210/211, ICH Q7, PIC/S, and WHO GMP, Vantage Hemp leverages a science-driven approach to fuel innovation and growth in the rapidly expanding CBD industry.

What will you do? This is a hands-on, full-time position with duties that include supporting the Quality Assurance Department's initiatives  at Vantage Hemp Co. and serving as a vital member of the Site Leadership Team, reporting directly to the Director of Quality Assurance & Regulatory Affairs.  This position supports the setup/ongoing maintenance of all QA systems, i.e., change control,  training, investigations, etc.  This role drives improvement activities, including developing and maintaining comprehensive quality metrics. The position will partner with other functional groups to make recommendations, set goals, and implement process improvements. This position can lead teams and facilitate learning and development opportunities for the greater organization.  Learn more about Vantage Hemp, their process, and their products at  Vantagehemp.com  or follow on Twitter @vantagehemp   

Compensation: $75,000 to $90,000 (Depending on Experience)
Schedule: Monday-Friday 

What are you responsible for?

• Establishes, manages, and coordinates all Quality Assurance and Quality related activities.
• Ensures compliance of QMS with GMP regulations, including FDA, WHO, Q7, LATAM and the EU.
• Conducts internal audits of processes and records and assists with client audits
• Conducts external vendor audits
• Assists with bringing on new products and processes to ensure GMP compliance
• Working with subject matter experts in documenting quality events in the Quality Management System
• Provides Quality leadership and direction to support business operations and develop the site quality strategy and by instilling a culture of Quality and continuous improvement.
• Prepares and presents meetings for Product Quality Review and Management Reviews
• Conducts product releases and coordinates with team members to ensure timely product releases
• Assists in establishing and implementing a corporate training program as it relates to Quality Assurance
• Supports customer interaction for quality requirements, incident handling, and quality performance.
• Manages critical quality incidents and supports quality operations.
• Participates in the site implementation of corporate Quality policies.
• Participates in developing QA staff, ensuring all team members have set appropriate goals and objectives.
• Additional duties as assigned.

Qualifications and Experience:

• 3+ years of hands-on experience in Quality in an FDA or ISO-regulated industry (e.g., Dietary supplements, pharmaceuticals) with supervisory experience.
• 2+ years of previous management experience with teams of 2 or more
• Proven experience developing teams.
• Experience with Veeva Vault is preferred.

Specialized Skills:

• Ability to create, write, and maintain Standard Operating Procedures.
• Comfortable in small group settings, providing training on documented procedures and processes.
• Excellent written and verbal communication/presentation skills and organizational skills.
• Logical in thought and detail-focused.
• Analytical approach to problem-solving and decision-making.
• Must be 18 years of age or older.