Lead Candidate · 3 weeks ago
QA Batch Review & Disposition Manager
Fishers, IN
Full-time
Onsite
Senior Level
6+ years expINCOG Biopharma Services is a world-class CDMO specializing in parenteral injectable drugs, and they are seeking a QA Batch Review & Disposition Manager. The Manager will lead batch reviews, make critical disposition decisions, and ensure compliance with regulatory requirements while fostering a culture of quality and precision within the organization.
EmploymentHuman ResourcesRecruitingStaffing Agency
Hiring Manager
Megan Peacock
Responsibilities
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
Qualification
Required
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
Preferred
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
Benefits
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
Company
Lead Candidate
Lead Candidate is a recruiting company that provides staffing, talent management, and HR solutions for the pharma sector.
Founded in 2021Newcastle Upon Tyne, Newcastle upon Tyne, GBR
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase