Director of Quality

2 weeks ago

Lexington, United States Kindeva Drug Delivery Full time

Job DetailsJob LocationCompany Headquarters - Lexington, KYPosition TypeFull TimeEducation Level4 Year DegreeJob ShiftDayJob CategoryQA - Quality ControlDescriptionSummary:Responsible for the management of the company's quality assurance and laboratory functions with the goal of ensuring that drug development, registration, and commercialization activities are compliant with all applicable regulatory requirements and guidelines. Essential Duties:Lead the development, implementation and management of GMP quality and compliance systems and policies, including the timely development of QA processes and proceduresOversee the implementation of SOPs, specifications, and protocols necessary for the laboratory.Manage the day-to-day activities of the QA group and the quality systems with respect to the writing, review and approval of GMP documentation and business practicesOversee the management of the laboratory in compliance with FDA, OSHA and DEA regulationsLead efforts to ensure the site operates in compliance with internal policies, health authority/regulatory regulations, and evolving expectationsAuthor or review, and compile regulatory documents in CTD format for submissions.Establish the quality plan, strategy, and objectives for the siteInspire transformative thinking and motivate employees to deliver benchmark performanceDevelop and Chair the site quality management review board to continuously improve quality and compliance performance by reviewing KPIs and sharing best practices, lessons learned, evolving regulations/expectations and inspection findingsSupport product robustness efforts and other initiatives to improve product quality and complianceDevelop and monitor quality performance metrics, for example incident reports and QC schedule attainmentAssure compliance with all company SOPs, directives, policies, testing requirements and regulatory agency guidelines and expectationsLead and foster an environment of continuous improvement in all QA, QC, and compliance functions/systems at the siteContribute to and support overall site goals and initiativesDevelop and share best practices and collaborate throughout the organization to implement continuous quality, efficiency and cost-savings initiativesServe as residentcurrent good manufacturing practices (cGMP) QA expertin support of document control, change control, and validationDirect and manage the Change Management ProgramSupport plant management groups on new products and changes to products, processes, and services to achieve a consistent approach to qualityDirect quality and compliance process improvements and goals using current regulations and demonstrated best practicesHire, train and develop staff and conduct Performance Reviews to assure highly effective, team-oriented contributors to company's successDevelop and support departmental strategic goals to assure the highest quality standards and regulatory complianceProvide information to customers on quality systems and quality improvement plans.Interact with Clients and Partners to ensure customer satisfactionProvide QA input to technology transfersProvide QA oversight and follow-up on non-product specific incidents related to utilities, facilities and equipmentParticipate in all plant activities to ensure cGMP compliant manufacturing and regulatory inspection readinessDevelop and manage the PAI readiness planLead internal and external GMP audits, including the timely preparation of audit reports and responsesLead vendor auditing and qualification programPerform review of regulatory submission documentsAdvise senior management on findings and recommendations related to qualityPerform Manufacturing Batch review and dispositionMaintain current knowledge of regulatory developmentsOversee out-of-specification investigations and batch deviations along with implementation of respective corrective and preventive actionsOversee the budgets for the laboratoryProvide oversight of DEA controlled substance inventories, SOPs, and reports. Assure compliance with DEA controlled substance regulations including registrations, reporting, and documentationOther duties as assignedQualificationsBS in chemistry, biology or related field10 years experience in quality managementExtensive technical experience in analysis and development of pharmaceuticalsExcellent technical writing, project management, and organizational skillsSuperior interpersonal and communication skills and demonstrated ability to effectively communicate with all levels of the organizationFamiliar with the necessary components of facility qualification and validation activitiesExtensive knowledge of cGMP regulations and ICH guidelinesFlexible, adaptable, self-motivated and able to work well independently and across teamsAbility to work in a lean, action oriented organization and demonstrate a strong work ethicAbility to identify the need for and implement change while inspiring confidence and enthusiasm within the teamDemonstrated knowledge of modern analytical techniques, including HPLCExperience in developing specifications for raw materials and finished productsQualified to work with controlled substancesDemonstrated ability to make and act on decisions while balancing speed, quality, and riskSignificant knowledge in drug product manufacturing, quality assurance, validation, quality control, regulatory affairs, and technology transferAbility to think clearly and decisively; remain calm under adverse conditionsDemonstrated ability to work independently or in groups in a complex, changing environmentAbility to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitmentsAbility to provide innovative, compliant ideas, or alternatives that create value, including seeking new information and external insights

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