Posted: Wednesday, November 08, 2023 02:32 AM


Company Description6th largest generic pharmaceutical company located in the US. Extremely low cost of living area, close to outstanding medical facilities and physicians. Excellent pay, comprehensive benefits, annual bonus and a very generous relocation package. Growing company with excellent advancement opportunities.Job DescriptionJob Description Job Title Senior Director, Laboratory Technical Services Function Quality Location(s) Huntsville AL Department Quality Systems Direct Reports (list) Tech Services; Stability Raw Material Manager; QC Compliance; Laboratory Training Reports to (title) VP Quality - Generics Job Summary - 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 Company 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. All incumbents are responsible for following applicable Division & Company policies and procedures. Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc. QC Laboratory Center of Excellence to maintain consistency in processes through collaboration with each site Quality Assurance departments. Key Accountabilities - Stability  Ensure consistency in program execution across Company network (protocols, reports, procedures, etc.).  Maintain compliance to application requirements and evolving regulations.  Review data to determine trends that may affect product shelf life. Raw Materials  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. Lean Labs  Establish metrics to monitor operation performance and evaluate/ implement enhancements that improve compliance and efficiency. Compliance  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. QC Technical Services  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. Other  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. Qualifications Education & Experience Minimal acceptable level of education, work experience and certifications required for the job  Minimum of Master's Degree in Analytical Chemistry, Ph.D. 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. Knowledge  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 Skills and Abilities:  Strong capability as organizational change agent.  Strong leaderships, team building, and communication skills.  Strong focus on quality and proven ability to apply a high degree of integrity.  Identify the developmental needs of others and provide coaching, mentoring, and encouragement to help others to improve their knowledge or skills.  Customer/Stakeholder focused (understand business plans and operating environment).  Demonstrated skills in project management and facilitation.  Clear problem-solving and decision-making skill.  Ability to lead and participate on teams with shared responsibility for outcomes and decision-making, and ability to manage and lead meetings Source:

• Location: Downtown Auburn,University Heights,Cary Woods,Grove Hill Downtown Auburn,University Heights,Cary Woods,Grove Hill Alabama

• Post ID: 125771738 Auburn

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