INCOG BioPharma Services Careers - Senior Director of Quality Control

INCOG BioPharma•Fishers, IN

55d•Onsite

About The Position

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.

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
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
Comprehensive knowledge of regulatory requirements pertaining to GMP laboratories

Nice To Haves

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

Responsibilities

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