QA Manager, Batch Review and Disposition

Quality Assurance Manager - Batch Review and Disposition Summary Working closely with the Senior Director of Quality, the Manager will be instrumental in championing and developing our new organization's batch review excellence and a culture of precision, scientific rigor, and timely product release decisions. The Manager will need to successfully lead comprehensive batch reviews, make critical disposition decisions, and ensure compliance with all regulatory requirements. The Quality Assurance Manager - Batch Review and Disposition will exemplify excellent analytical skills and develop productive, quality-focused working relationships with Manufacturing, Quality Control, , and cross-functional teams. The Manager will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex quality decisions and batch disposition rationales to a range of target audiences. The Manager will thrive in a team environment but will also work autonomously utilizing strong scientific judgment and decision-making skills. Essential Job Functions: • Lead comprehensive batch record review processes for sterile injectable drug products, ensuring completeness, accuracy, and compliance with approved manufacturing procedures and specifications. • Make critical batch disposition decisions (release, reject, or investigate further) based on thorough evaluation of manufacturing data, in-process testing results, and finished product testing. • Establish and maintain batch review procedures that ensure timely and accurate evaluation of all manufacturing batches while maintaining the highest quality standards. • Lead investigation of manufacturing deviations and out-of-specification results, determining impact on product quality and appropriate corrective and preventive actions. • Collaborate with Quality Control to review analytical testing data, certificate of analysis information, and trending of quality attributes across multiple batches. • Partner with Manufacturing Operations to review batch execution data, process parameters, environmental monitoring results, and equipment performance records. • Ensure compliance with cGMP requirements and regulatory expectations for batch review and release, maintaining detailed documentation of all disposition decisions. • Develop and maintain batch review checklists and standard operating procedures to ensure consistent and thorough evaluation processes. • Lead cross-functional batch review meetings to discuss complex cases, unusual events, and trending of quality data across product lines. • Maintain batch disposition databases and generate reports on batch release metrics, cycle times, and quality trends for senior management. • Ensure readiness for regulatory inspections by maintaining comprehensive batch files and being prepared to justify all disposition decisions to regulatory authorities. • Train and develop team members on batch review processes, quality systems, and regulatory requirements specific to sterile injectable products. • Utilize electronic batch record systems and quality management systems (Veeva, LIMS, etc.) to ensure data integrity and efficient review processes. • Apply statistical analysis to identify trends in manufacturing performance and product quality, implementing continuous improvement initiatives. • Stay current with regulatory guidance on batch review and release requirements from FDA, EMA, and other global regulatory authorities. Special Job Requirements: · Bachelor’s Degree required; degree preferred to be in Science (Chemistry, Biology, Biochemistry, Microbiology etc.) · Minimum of 6 years of Quality Assurance experience in pharmaceutical manufacturing with at least 4 years focused on batch review and disposition. · Expert knowledge of cGMP requirements for batch review, release, and disposition decisions in sterile injectable manufacturing. • Experience with regulatory inspections and ability to defend batch disposition decisions to regulatory authorities. • Proficiency with electronic quality systems including LIMS and document management systems. • Excellent analytical and problem-solving skills with demonstrated ability to make risk-based quality decisions under time pressure. • Strong project management skills with ability to prioritize multiple batch reviews while meeting customer delivery commitments. • Exceptional attention to detail and ability to identify potential quality issues that may not be immediately obvious. Additional Preferences: · Hands-on experience with aseptic manufacturing Quality. · Isolator-based aseptic processing experience. · 3+ years of experience as a people leader or supervisor. · Experience with building processes and procedures. · Experience with Continuous improvement, Six Sigma, and/or Lean principles. Additional 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.