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Senior Director, Laboratory Services
Location: AL - Huntsville
Position ID: P0004536
Since 1983, the people of Qualitest have dedicated themselves to researching, manufacturing and delivering affordable, high-quality generic pharmaceuticals. With manufacturing facilities in Huntsville, Alabama and Charlotte, North Carolina, the company is now ranked in the industry top ten, and has a portfolio exceeding 600 products.
Our vast range of prescription and over-the-counter products comprises tablets, capsules, liquids, suspensions, creams, and ointments. These are used to treat a wide variety of therapeutic categories, including antihypertensives, analgesics, antibiotics, cough/cold, antidepressants, antipsychotics, and others. Consumers find our products at all major retailers, as well as locally owned and operated pharmacies.
* Define, develop and deploy key quality systems for the operations of the laboratory. Implement a mechanism for the monitoring of the performance of such system and create ongoing improvements.
* Lead specific initiatives across all sites to ensure standardization and effectiveness for key processes. Examples include; Lean Laboratory initiative, deployment of LIMS, standardization of raw material testing requirements, etc.
* Develop, continually update and deploy 3-5 year Laboratory instrumentation strategy to achieve consistent quality, improved cycle time and efficiencies.
* Develop and deploy a robust Analyst training program. Monitor and improve effectiveness of such a program on an ongoing basis.
* Manage the Marketed Product Stability program across Qualitest and ensure compliance to GMP/ICH requirements. Establish a system for appropriate escalation procedure for actions related to stability trends and investigations.
* Lead Laboratory Technical Operations projects related to revisions to USP monographs or ICH modifications to current methods or practices, new supplier qualifications, and alternate manufacturing systems.
* Proactively participate in external professional groups including FDA to learn emerging requirements and proactively integrate within Qualitest.
* Build and deploy a process across all plants to execute the Laboratory testing methods for the new ANDAs. During technical transfer and post launch, ensure methodology improvement (quality, cycle time, and efficiencies issues are identified and improved upon.
* Build a team of capable resources working in a collaborative environment promoting quality principles throughout the organization. Develop a culture in line with the Leadership Attributes.
* Ensure consistency in program execution across Qualitest network (protocols, reports, procedures, etc.)
* Maintain compliance to application requirements and evolving regulations
* Review data to determine trends that may affect product shelf life
* Collaborate with plant level QC managers to ensure consistency in specifications, test method execution, best practices, etc.
* Monitor regulations to understand and implement changes as necessary, and ensure monograph changes are implemented consistently
* Establish metrics to monitor operation performance and evaluate/ implement enhancements that improve compliance and efficiency
* Implement training programs to enhance chemists’ knowledge and capability and monitor the training effectiveness through appropriate metrics
* Ensure adherence to cGMP, compendial requirements, CFR, DEA, and company SOPs.
* Ensure consistency in reporting processes
* Support LIMS implementation.
* Improve robustness of existing methods to enhance compliance and output
* Review method and specification changes
* Execute supplier qualification requirements
* Interface with R&D for method transfer
* Evaluate technology and automation platforms to improve reliability and efficiency.
* Review and approve technical documents, reports, methods, specifications, SOPs, change controls, COAs, etc.
* Participate in outside organizations to ensure Qualitest is aware of current industry practices as well as emerging trends and technologies
Experience and Education Requirements:
* Minimum of Bachelor’s Degree in Analytical Chemistry, Master’s Degree preferred.
* 10-15 years of experience in a commercial laboratory setting
* Minimum of 7-10 years of management experience in a pharmaceutical quality control environment.
* Experience in managing multi-shift laboratory operations required.
* Experience in managing multiple locations preferred.
* Prior work experience in pharmaceutical RD method development and validation laboratory preferred.
* Strong knowledge of all current state, federal and local standards and regulations, e.g., cGMP, GLP, OSHA, EEOC, EPA, and DEA.
* Strong knowledge of 21-CFR-210, 21-CFR-211 and ICH Guidelines
* Strong technical and quality background related to pharmaceuticals
Qualitest is an equal opportunity employer.