INCOG BioPharma Services
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Senior Director of Quality Control
role at
INCOG BioPharma Services .
The Senior Director of Quality Control will lead our quality control operations in support of sterile injectable drug product filling, inspection, assembly, and packaging operations. This senior-level position reports directly to the VP Quality and oversees 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.
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.
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.
Additional Preferences
Experience in CDMO/contract manufacturing environment.
Extensive experience in sterile injectable manufacturing environment.
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.
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.
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Senior Director of Quality Control
role at
INCOG BioPharma Services .
The Senior Director of Quality Control will lead our quality control operations in support of sterile injectable drug product filling, inspection, assembly, and packaging operations. This senior-level position reports directly to the VP Quality and oversees 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.
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.
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.
Additional Preferences
Experience in CDMO/contract manufacturing environment.
Extensive experience in sterile injectable manufacturing environment.
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.
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.
#J-18808-Ljbffr