QA Batch Review & Disposition Manager

QA Batch Review & Disposition Manager

INCOG Biopharma Services in Indianapolis, IN is hiring a QA Batch Review & Disposition Manager. 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 QA Batch Review & Disposition Manager 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.

There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.

At INCOG, they are more than just a CDMO. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At their core, that is who they are—a dedicated team that believes they can always be better.

Join the team at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients, for yourself, and for INCOG’s clients.

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.

Candidate 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.

Why INCOG?

• Paid time off, based on tenure
• 11 paid holidays
• 401(k) plan with company match up, vested immediately
• Choice of health & wellness plans
• FSA and HSA options
• Onsite wellness facility
• Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.