Kindeva is a leading global contract developer and manufacturing organization (CDMO) with delivery platform experience expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch, and Nasal Spray Technologies. The Lexington location develops, manufactures, and commercializes prescription nasal spray products and is experiencing increasing continuous growth. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture more tomorrows.Job Summary:The Senior Manager of Quality Assurance at Kindeva Drug Delivery/Summit Biosciences will be responsible for ensuring the highest level of quality and compliance for all products and processes at our Lexington, Kentucky facility. This individual contributor role will play a critical role in developing and maintaining quality systems, managing audits and inspections, and driving continuous improvement initiatives. The ideal candidate will have a strong background in quality assurance, strong leadership skills, and a passion for driving excellence in the pharmaceutical industry.Compensation & Benefits:This is a full-time position with a competitive salary and benefits package. Benefits include medical, dental, and vision insurance, 401K with company match, paid time off, and opportunities for career growth and development.Responsibilities:Lead the development, implementation, and management of GMP quality and compliance processes and policies, including the timely development of QA processes and procedures.Manage the day-to-day activities of the QA group with respect to the writing, review, and approval of GMP documentation and business practices.Lead efforts to ensure the site operates in compliance with internal policies, health authority/regulatory regulations, and evolving expectations. Interact with teams and lead continuous improvement projects, partner with Operations to ensure on-time delivery of quality products.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 findingsDevelop and monitor quality performance metrics.Assure compliance with all company SOPs, directives, policies, testing requirements, and regulatory agency guidelines and expectationsLead and foster an environment of continuous improvement in all 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-saving initiativesServe as resident current good manufacturing practices (cGMP) QA expert in support of document control, change control, and validationSupport 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 ensure highly effective, team-oriented contributors to the company's successProvide 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 readinessLead internal and external GMP audits, including the timely preparation of audit reports and responsesLead vendor auditing and qualification programAdvise 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 actionsProvide oversight of DEA-controlled substance inventories, SOPs, and reports. Assure compliance with DEA controlled substance regulations including registrations, reporting, and documentation.Requirements:BS in chemistry, biology, or a related field10+ years of GMP quality experience5 years of supervisory/management experienceExtensive technical experience in the 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 teamExperience 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 insightsEEOC Statement:Kindeva Drug Delivery/Summit Biosciences is an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
