Senior Director of Quality Control

The 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 commitments
• QC Microbiology Laboratory Management: Oversee sterility testing programs, environmental monitoring systems, and microbiological testing protocols to maintain sterile manufacturing environment integrity
• Incoming Materials Testing: Lead quality control testing programs for raw materials, components, and packaging materials, ensuring all incoming materials meet established specifications prior to use
• Stability Program Leadership: Develop, implement, and maintain comprehensive stability testing programs in accordance with ICH guidelines, including protocol development, sample management, data analysis, and regulatory reporting
• Analytical Method Transfer: Manage team responsible for analytical method transfer activities, including method validation, technology transfer from clients, and implementation of new analytical procedures
• Establish and maintain QC laboratory strategic vision aligned with business objectives and regulatory requirements
• Drive continuous improvement initiatives to enhance laboratory efficiency, data integrity, and compliance
• Collaborate with cross-functional teams including Manufacturing, Quality Assurance, and Project Management
• Ensure laboratory readiness for regulatory inspections and client audits
• Lead, mentor, and develop QC laboratory personnel across chemistry and microbiology functions
• Foster a culture of scientific excellence, regulatory compliance, and continuous learning
• Manage resource allocation, staffing levels, and succession planning for laboratory operations
• Drive training programs to maintain technical competency and regulatory knowledge
• Ensure 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 protocols
• Oversee CAPA implementation for laboratory-related quality issues
• Support regulatory submissions with analytical data packages and technical documentation

Special Job Requirements:

• Degree in Chemistry, Microbiology, or related scientific discipline
• Minimum 12-15 years of pharmaceutical industry experience with at least 8 years in leadership roles. G_ive me a summary of your leadership experience? Giving details on specific departments._
• Proven track record managing analytical chemistry and microbiology laboratories
• Strong understanding of microbiological testing methods, sterility testing, and environmental monitoring
• Experience with stability program design and execution per ICH guidelines
• Experience with laboratory information management systems (LIMS)
• Experience with budget management and resource allocation
• Track record of driving operational excellence and continuous improvement.  Give examples
• Comprehensive knowledge of regulatory requirements pertaining to GMP laboratories.  What regulatory inspections have you supported?

Additional Preferences:

• Experience in CDMO/contract manufacturing environment
• Extensive experience in sterile injectable manufacturing environment preferred
• Previous experience with FDA, EMA, or other regulatory agency inspections
• Six Sigma or Lean certification
• Deep knowledge of analytical testing methods including HPLC, GC, and related techniques
• Proficiency in analytical method transfer and validation processes
• Knowledge of advanced analytical techniques and emerging technologies

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.

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