Director, Quality Control Lab

Director, Quality Control Lab

The Director, Quality Control Laboratories is responsible for day-to-day operations of the Quality Control testing laboratories supporting all QuVa production sites. This position coordinates, leads group activities, and develops and implements the department's short and long-term goals to assure compliance with cGMPs and agreement with QuVa business initiatives. Manages and develops teams within the Department to support Company activities. Serves as technical expert for the site in the areas of chemistry, analytical methods, microbiology and test method transfer.

Other responsibilities include department budget, supervision of the department team, hiring and development of personnel, technical assistance in product or process investigations and sponsorship of a quality and compliance focused culture that embraces RFT (right first time) and CI (continuous improvement) expectations. Responsible for the support of site wide objectives through the reporting of department Key Performance Indicators (KPI). The position will provide a technical lead in interdisciplinary teams assembled for projects (e.g., process development, new product development, etc). Troubleshoots technical problems and provides remedial actions, and identifies improvements to analytical methods.

Establishes and maintains cooperative cross-functional relationships with peers in Quality, Operations, Technical Support, Pharmacy Services, and Supply Chain to meet site and corporate objectives.

Responsibilities may include :

• Prepares resource analysis for the execution of projects. Prepares and manages the Department operational budget
• Establishes and maintains effective cross functional relationships. Provides necessary support to other Departments
• Provides leadership in the training program of laboratory staff. Evaluates subordinates through reviews and periodic discussions. Recommends future development objectives. Fosters team work, customer service and cross-functionality
• Prepares / reviews / approves departmental documentation (i.e. SOPs, Analytical Method Transfer protocols)
• Assures that departmental SOPs are followed and are compliant with current Good Manufacturing Practices (cGMP) and Company policies. Operates the laboratories in a safe and hazard-free manner
• Leads the routine Quality Control release testing laboratories to ensure testing is completed on time in a compliant manner
• Leads the corporate Stability laboratory to ensure products meet their BUD and with establishing BUD for new products
• Applies fundamental knowledge of Analytical Chemistry and advanced technologies in analysis, interpretation and understanding of test results, for both qualitative and quantitative analyses
• Provides expertise and assists in writing investigation reports for Laboratory investigation, Operations investigations, and Cross-functional investigations
• Recommends or makes changes to tests, assays and specifications to ensure reliability, accuracy and their adequacy for the monitoring of product quality
• Provides customer support as needed
• Other duties as assigned

Minimum Requirements for this Role :

Benefits of Working at Quva :

About Quva :

Quva provides industry-leading health-system pharmacy services and solutions, including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of pharmacy. Quva Pharma's multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStream partners with health systems to aggregate, normalize, and analyze large amounts of complex data across their sites of care, and through proprietary machine learning, transforms data into actionable insights supporting revenue optimization, script capture, inventory management, drug shortage control, and more. Quva's overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care.

Quva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quva's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with Quva is "at will."