DescriptionThe Senior Director of Quality Control to lead our quality control operations in support of sterile injectable drug product filling, inspection, assembly, and packaging operations. This senior-level position will report directly to the VP Quality and oversee all aspects of quality control testing, from incoming materials through final product release, ensuring compliance with FDA, ICH, and cGMP requirements while supporting our mission to deliver quality products to patients.This position offers the opportunity to lead a critical function within a growing CDMO, directly impacting patient access to life-saving medications while building a world-class quality control organization.Essential Job Functions:QC Chemistry Laboratory Management: Direct all final product release testing and on-demand analytical testing operations, ensuring timely and accurate results to support manufacturing schedules and regulatory commitmentsQC Microbiology Laboratory Management: Oversee sterility testing programs, environmental monitoring systems, and microbiological testing protocols to maintain sterile manufacturing environment integrityIncoming Materials Testing: Lead quality control testing programs for raw materials, components, and packaging materials, ensuring all incoming materials meet established specifications prior to useStability Program Leadership: Develop, implement, and maintain comprehensive stability testing programs in accordance with ICH guidelines, including protocol development, sample management, data analysis, and regulatory reportingAnalytical Method Transfer: Manage team responsible for analytical method transfer activities, including method validation, technology transfer from clients, and implementation of new analytical proceduresEstablish and maintain QC laboratory strategic vision aligned with business objectives and regulatory requirementsDrive continuous improvement initiatives to enhance laboratory efficiency, data integrity, and complianceCollaborate with cross-functional teams including Manufacturing, Quality Assurance, and Project ManagementEnsure laboratory readiness for regulatory inspections and client auditsLead, mentor, and develop QC laboratory personnel across chemistry and microbiology functionsFoster a culture of scientific excellence, regulatory compliance, and continuous learningManage resource allocation, staffing levels, and succession planning for laboratory operationsDrive training programs to maintain technical competency and regulatory knowledgeEnsure all QC operations comply with FDA 21 CFR Part 211, ICH guidelines, and applicable pharmacopeial standards (USP, EP, JP)Maintain laboratory quality systems including equipment qualification, method validation, and data integrity protocolsOversee CAPA implementation for laboratory-related quality issuesSupport regulatory submissions with analytical data packages and technical documentationSpecial Job Requirements:Degree in Chemistry, Microbiology, or related scientific disciplineMinimum 12-15 years of pharmaceutical industry experience with at least 8 years in leadership rolesProven track record managing analytical chemistry and microbiology laboratoriesStrong understanding of microbiological testing methods, sterility testing, and environmental monitoringExperience with stability program design and execution per ICH guidelinesExperience with laboratory information management systems (LIMS)Experience with budget management and resource allocationTrack record of driving operational excellence and continuous improvementComprehensive knowledge of regulatory requirements pertaining to GMP laboratoriesAdditional Preferences:Experience in CDMO/contract manufacturing environmentExtensive experience in sterile injectable manufacturing environment preferredPrevious experience with FDA, EMA, or other regulatory agency inspectionsSix Sigma or Lean certificationDeep knowledge of analytical testing methods including HPLC, GC, and related techniquesProficiency in analytical method transfer and validation processesKnowledge of advanced analytical techniques and emerging technologiesAdditional info about INCOG BioPharma Services:At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.By submitting your resume and details, you are declaring that the information is correct and accurate.
INCOG BioPharma Services