Manager, Quality Assurance - Facilities Maintenance
Quva
Summary
Our Manager, Quality Assurance – Facilities Maintenance plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include leading the oversight and compliance of all site-related facility maintenance and engineering projects, repairs, work orders and processes within the pharmaceutical manufacturing facility. This position operates within the legal and regulatory compliance, ensuring that any and all facilities related activities are documented when performed in accordance with site compliance while upholding quality standards.
Job description
What Manager, Quality Assurance - Facilities Maintenance Does Each Day:
- Manages Quality Assurance – Facility / Maintenance staff
- Reviews, approves and ensures completion of all facility related work orders for the manufacturing site
- Ensures compliance with clean room standards during all facility related projects
- Oversees failure and discrepancy investigations and documenting investigations on process deviations or equipment malfunctions related to facility / maintenance work orders, processes and/or jobs performed
- Develops and provides oversight to identification and implementation of appropriate corrective actions and preventive actions
- Responsible for routine evaluation of environmental monitoring program data supporting facilities/maintenance work orders ensuring activities performed maintain compliance with site policies and procedures
- Maintains compliance with FDA 503B and cGMP guidelines / state and federal laws
- Responsible for maintaining Quality Assurance records associated with facilities or maintenance
- Responsible to maintain all testing equipment records in compliance, calibration, and certification
- Assists in developing policies and procedures related to QA Facility / Maintenance
- Promptly communicates with appropriate departments regarding discrepancies, variances, or issues
- Enforces applicable personnel policies and procedures
Our Most Successful Quality Assurance - Facilities Maintenance Managers:
- Have strong technical writing and verbal/written communication skills
- Develop action plans to meet a specific objective including identification and methods of tasks, milestones, resources requirements and metrics
- Possess time management skills
Minimum Requirements for this Role:
- Bachelor’s Degree in Life Science or another related field
- 3+ year’ supervisory or management experience
- 5+ years’ experience in Quality Assurance / cGMP / FDA regulated industry
- Understanding of Good Documentation Practices
- Experience with Maintenance Safety practices and protocols
- Knowledgeable in ISO 5/7 environment cleanroom gowning
- Knowledge of manufacturing processes, procedures and basic facilities maintenance functions
- Able and willing to walk, stoop, stand, bend, and lift up to 50 lbs. throughout each shift, with or without reasonable accommodation
- Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas
Requirements
- Bachelor’s Degree in Life Science or another related field
- 3+ years supervisory or management experience
- 5+ years experience in Quality Assurance / cGMP / FDA regulated industry
- Understanding of Good Documentation Practices
- Experience with Maintenance Safety practices and protocols
- Knowledgeable in ISO 5/7 environment cleanroom gowning
- Knowledge of manufacturing processes, procedures and basic facilities maintenance functions
- Able and willing to walk, stoop, stand, bend, and lift up to 50 lbs. throughout each shift, with or without reasonable accommodation
- Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- 22 Paid Days Off
- 8 Paid Holidays
- Career Advancement Opportunities
Company overview
Quva is a national, industry-leading provider of health-system pharmacy services and solutions, operating at the intersection of pharmaceutical manufacturing and healthcare analytics. Founded in 2015 and headquartered in Sugar Land, Texas, the company has established itself as a prominent player in the 503B sterile injectable outsourcing market. Quva operates FDA-registered 503B outsourcing facilities that provide hospitals with essential medications in ready-to-administer formats, leveraging cGMP expertise and pharmaceutical manufacturing capabilities across multiple production facilities. The company's comprehensive platform combines sterile injectable compounding with advanced data analytics through its Quva BrightStream division, which offers AI-powered predictive analytics and data insights software solutions. These tools help health systems aggregate, normalize, and analyze complex data across care sites, supporting revenue optimization, script capture, inventory management, and drug shortage control. With over 1,000 employees and serving more than 3,500 health systems nationwide, Quva has secured significant funding, including a $275 million debt financing round in 2021. The company's integrated approach transforms pharmacy management by enabling healthcare providers to operate more efficiently and effectively while delivering high-quality patient care.