<p>The QA Technical Manager will lead the development and continuous improvement of programs related to QC data review, analytical and microbiological test methods, and validation documentation. This role will collaborate with the Director of Quality Assurance to foster a culture of quality, efficiency, and continuous improvement. The QA Technical Manager will navigate audits, identify operational gaps, and champion a quality mindset across the organization.</p> <p>Essential Job Functions:</p> <ul> <li>Lead the development and improvement of laboratory data review processes for QC Chemistry and Microbiology, including incoming materials, in-process, finished products, and stability testing. </li><li>Train QA team members on QC data review, testing methods, laboratory investigations, and EM trend reports. </li><li>Collaborate with Quality Control to strategize and direct the testing, data analysis, and review processes. </li><li>Ensure readiness for rapid decision-making during deviation events, product segregation, and corrective action implementation. </li><li>Serve as a subject matter expert in laboratory investigations, utilizing root cause analysis and risk mitigation tools. </li><li>Partner with EH&S and Operations management to communicate safety expectations and enforce SOPs and compliance requirements. </li><li>Maintain inspection-readiness in QC laboratories, leveraging knowledge of cGMPs and regulatory standards, and serve as a key contact during audits. </li><li>Stay informed on evolving regulatory trends and best practices through continuous education, networking, and industry resources. </li><li>Ensure data integrity across Quality Assurance and Quality Control systems (e.g., Veeva, SCADA, BMS, CMMS). </li><li>Use technical and statistical analysis to track laboratory investigations, resolve technical issues, and implement continuous improvement plans. </li><li>Partner with Process Engineering, MS&T, and Validation to develop and maintain a compliant Validation program covering Commissioning, Qualification, and Validation activities. </li><li>Build strong, customer-centric relationships with subordinates, colleagues, customers, suppliers, and partners. </li><li>Influence positive outcomes without direct reporting authority and lead with integrity, empathy, and positivity. </li><li>Demonstrate exceptional written and verbal communication skills, conveying complex issues clearly to diverse audiences. </li><li>Navigate audits with transparency and humility, recognizing knowledge gaps and deferring to subject matter experts when needed. </li><li>Thrive both in team settings and independently with strong organizational and self-management skills. </li><li>Commit to a culture of quality, attention to detail, and on-time delivery. </li></ul> <p>Special Job Requirements:</p> <ul> <li>Bachelor's Degree required; degree preferred to be in Science (Chemistry, Biology, or Biochemistry); advanced degree preferred. </li><li>Minimum of 5 years of Quality Control and/or Quality Assurance experience in biopharma or similarly regulated industry. </li><li>High level of understanding and oversight of Quality Control testing processes in both QC Chemistry and QC Microbiology for aseptic manufacturing. </li><li>High level of understanding and oversite of contamination controls, manufacturing processes, and validation requirements. </li><li>Prior experience and comfort with making risk-based decisions to ensure product quality is required. </li><li>Possesses an excellent working knowledge, understanding, and experience with practical implementation of FDA, EMA, and other regulatory authority expectations for Operations and Quality. </li><li>Exceptional computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.). </li></ul> <p>Additional Preferences:</p> <ul> <li>2+ years of experience as a people leader or supervisor. </li><li>Certification in Risk Management, Quality Process Analysis, Technical Writing, and/or Quality Investigation. </li><li>Hands-on experience with aseptic manufacturing Quality. </li><li>Isolator-based aseptic processing experience. </li><li>First-hand experience participating in operation floor inspection tours related to Quality Control and/or Validation. </li><li>Experience with building processes and procedures. </li><li>Experience with Continuous improvement, Six Sigma, and/or Lean principles. </li></ul> <p>Additional info about INCOG BioPharma Services:</p> <p>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.</p> <p>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.</p> <p>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.</p> <p>By submitting your resume and details, you are declaring that the information is correct and accurate.</p>