Job Store Professional has partnered with a Pharmaceutical Manufacturer to fill their new and exciting Director of Quality position in Englewood, CO. If you’re seeking your next Direct Hire opportunity with a company whose foundation is built on integrity, innovation, collaboration, and values a good work-life balance, this could be the next career opportunity you’ve been patiently waiting for!

This is an on-site position based in Englewood, Colorado and will not offer remote or hybrid work. We are looking for someone to be hands on and able to work directly with the production, manufacturing and quality team.

General Description

This position reports to the VP, Site Quality. The Director, Quality oversees evaluations, tracking, trending, and monitoring of the Quality activities in a 503B outsourcing facility. The position is responsible for the assurance that the drug product has the safety, identity, strength, quality, and purity represented. The candidate should have an excellent understanding of cGMP requirements. The position requires an individual who works independently and in a team environment, experienced in cGMP requirements, quality assurance/control, attention to detail, and excellent communication with other functional areas and sites. 

Essential Functions of Director of Quality

Responsible for drug preparation and supporting activities including:

1. Manage employees who are responsible for all quality activities in a 503B facility.
2. Main point of contact for regulatory audits associated with FDA, Board of Pharmacy and customer audits
3. Achieves quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.
4. Meets quality assurance financial objectives by estimating requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions.
5. Develops quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories.
6. Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures.
7. Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods.
8. Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
9. Updates job knowledge by studying trends in and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
10. Enhances department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
11. Work with a team to ensure that the systems involved in a 503B outsourcing facility are in a state of control
12. Other duties as assigned to ensure appropriate quality practices

Supervisory Responsibilities

• Supervision of employees is required

Experience and Necessary Skills of Director of Quality

1. Knowledge and experience with the Pharmacy CO Code of Regulations, CO Board of Pharmacies, and US FDA cGMPs, preferably in a commercial compounding outsource facility
2. Knowledge and experience of compounding techniques, controlled environments, and compounding facilities
3. Knowledge of appropriate materials and conditions
4. Able to identify potential adverse issues
5. Excellent organization and documentation skills
6. BS or BA degree (in a scientific discipline desired); 
7. Knowledge and experience in a cGMP environment in manufacturing/laboratories

Benefits of Director of Quality

• Health insurance
• Dental Insurance
• Vision Insurance
• Flexible Spending Account, Health Savings Account, Disability Insurance, Life Insurance, PTO, Employee Assistance Program
• 401K Matching

Salary: $130K-$150K