Director of Quality

Founded in 2013 to fulfill customer demand for supplement contract manufacturing work in Utah, Pharmatech Labs has grown to be one of the premium full-service contract manufacturing supplement companies in the United States. Poised for substantial growth in 2024, Pharmatech develops and manufactures products on site, in a state-of-the-art, eco-friendly facility in Lindon, Utah.

Are you an experienced, hands-on Director of Quality with a passion for product quality and compliance? Do you have prior experience managing a Quality Control laboratory that ensures QMS requirements are effectively established and maintained? Reporting to the COO, the Director of Quality will have direct oversight for the development and implementation of the company-wide QMS, and all of its components.

Key Responsibilities:

• Direct and oversee quality department, establishing procedures to ensure products conform to established quality management standards.
• Formulate and develop quality control and quality assurance program goals and guidelines and ensures work conforms with approved company policy and standard operating procedures.
• Lead, coach, and mentor quality department; cultivate an environment of trust, teamwork, accountability, and self-confidence.
• Develop and maintain effective collaboration with cross-functional teams to drive continuous improvement initiatives.
• Oversee all quality control laboratory functions including raw material, bulk, and finish product testing.
• Compile and analyze quality performance data to identify areas for operational improvement. Develop reports and reporting processes for data and resulting analysis and recommendations.
• Audit and approve laboratory testing equipment qualifications, calibrations, and standard testing methods.
• Determine strategies to meet FDA, NSF, SQF, ISO and other international Quality requirements. Understand risks and implement mitigations for customer and business needs.
• Develop, maintain and review QMS and QA Department metrics.

Requirements:

• Bachelor of Science in technical or scientific discipline required.
• Proven experience in quality management, with 5+ years of experience in a management role.
• Training/experience and expertise is expected in the following: Quality Management System, including MDSAP, 21 CFR parts 7, 11, 806, 820, ISO 13485, 14971, 9001
• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
• Good judgment with the ability to make timely and sound decisions.
• Commitment to excellence and high standards
• Problem analysis and problem resolution at both a strategic and functional level.
• Strong leadership and interpersonal skills.
• Excellent communication skills, both written and verbal, with the ability to effectively communicate complex concepts
• Demonstrated ability to manage multiple priorities and tasks and resolve variances in
• Experience with JD Edwards a plus.

Compensation and Benefits:

• Medical, Dental, and Vision coverage available on the first of the month following 30 days of employment.
• 401K plan and company sponsored Life Insurance.
• 3 weeks of PTO + 8 Paid Holidays (Accrued and pro-rated based on your start date).
• Highly competitive Base Pay ($130k - $180K DOE) plus Bonus based on success achieving individual and company goals.

Work Environment:

• A large percentage of time spent in this role is in the production area where noise level can be moderate to high.

Physical Requirements:

• Frequently required to stand, walk, bend, kneel, crouch, balance, and reach
• Regularly lift and/or move up to 50 lbs.
• Push/Pull up to 300 lbs.

Pharmatech Labs is proud to be an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, national origin, ancestry, gender, gender identity and/or expression, genetic information, veteran status, disability, citizenship status, marital status, pregnancy, or any other characteristic protected by federal, state, or local employment discrimination laws.