QUVA-posted 3 months ago
$164,000 - $220,000/Yr
Full-time • Senior
Bloomsbury, NJ
Securities, Commodity Contracts, and Other Financial Investments and Related Activities

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.

  • 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.
  • Bachelor's degree in B.A. /B.S. Degree in Chemistry, Biochemistry, Microbiology or related field with significant experience.
  • 10+ years prior experience in a Quality/ cGMP / FDA regulated industry with 5+ years of supervisory or management experience.
  • Technical writing and communication skills.
  • Ten years of analytical chemical/microbiology laboratory and 5 years of management experience.
  • Pharmaceutical laboratory experience in analytical methods development and validation area is expected.
  • Preferably has experience with manufacturing of parenteral products.
  • Well versed in the compliance & quality requirements of 503B pharmaceutical industry and CGMP's and have demonstrated strength in problem solving and resolution.
  • Working knowledge of MS Office, especially Excel, Word, Outlook and PowerPoint.
  • Able to successfully complete a drug and background check.
  • Must be currently authorized to work in the United States on a full-time basis.
  • Comprehensive health and wellness benefits including medical, dental and vision.
  • 401k retirement program with company match.
  • A minimum of 25 paid days off plus 8 paid holidays per year.
  • National, industry-leading high growth company with future career advancement opportunities.
  • Annual incentive bonus, subject to program terms and guidelines.
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