Senior Manager, CMC Quality Operations

Position Title: Senior Manager, CMC Quality Operations

Department: CMC Quality Operations

Reports To: Director, CMC Quality Operations

Location: South San Francisco, CA– On-site 4 days per week (Mon to Thurs)

Job Overview

Kardigan is seeking an experienced and technically strong Senior Manager, CMC Quality Operations supporting Quality Control and Quality Assurance activities for clinical-stage small molecule drug substance, drug product, placebo, and finished goods manufactured and tested at external CDMOs. This role is hands-on and requires deep expertise in raw analytical data review, data trending, stability study management, and specification oversight, with additional responsibilities for batch disposition and technical change control management.

Essential Duties and Responsibilities

• Quality Control
  • Provide Quality Control oversight of analytical testing performed at CDMOs for drug substance, drug product, placebo, and finished goods.
  • Perform independent, in-depth review of raw analytical data, chromatograms, spectra, calculations, and system suitability to ensure data integrity and compliance with Kardigan specifications.
  • Assess analytical results against approved specifications and oversee investigations related to atypical or out-of-trend results in collaboration with CDMOs and internal stakeholders.
  • Author, revise, and maintain analytical specification documents.
  • Develop and own processes and platforms for tracking and trending of CDMO generated analytical data.
  • Establish and maintain systems for data lifecycle management, ensuring traceability, completeness, and audit readiness.
• Stability Study Management
  • Provide Quality Control oversight of stability studies once in execution, collaborating with internal and external stakeholders to ensure testing is performed as scheduled and managing deviations if they arise.
  • Review raw stability data from external testing laboratories.
  • Track, trend, and evaluate stability data across time points and conditions.
  • Author stability summary reports, including scientific justification of drug substance retest periods and drug product shelf-life in alignment with ICH guidelines.
  • Maintain stability protocols, schedules, and stability data repositories.
• Batch Disposition
  • Perform batch record review for drug substance, drug product, placebo, and finished goods manufactured at CDMOs.
  • Manage and maintain batch genealogy, ensuring full traceability across materials and manufacturing stages.
  • Prepare and complete Kardigan batch release documentation, including Certificates of Analysis and Certificates of Release.
• Documentation Management and Regulatory Submission Support
  • Author and revise SOPs, work instructions, and job aids supporting CMC Quality Operations.
  • Initiate, manage, and assess Technical Change Controls impacting specifications, stability programs, and quality processes.
  • Ensure alignment with GMP, GDP, and applicable regulatory expectations.
  • Support internal audits, health authority inspections, and CDMO audits as required.
  • Ensure all records are complete, accurate, contemporaneous, and inspection ready.
  • Author relevant sections of regulatory submissions.

Qualifications and Preferred Skills

• BS or higher in Chemistry, Biochemistry, or a related scientific discipline.
• 5+ years of progressive experience in Quality Control, Quality Assurance, or CMC Quality Operations within the pharmaceutical or biotechnology industry, preferably with small molecules.
• Strong technical expertise in a broad range of analytical techniques such as, but not limited to:
  • Liquid Chromatography (LC)
  • Gas Chromatography (GC)
  • ICP-OES
  • ICP-MS
  • Atomic Absorption Spectroscopy (AAS)
  • Infrared Spectroscopy
  • IP-HPLC-TOF-MS
  • IP-HPLC-UV-MS
• Hands-on experience with stability study management, data analysis, and report authoring.
• Experience overseeing analytical testing at CDMOs.
• Proven experience managing Change Control within a GMP environment.
• Strong knowledge of GMP, GDP, ICH, and pharmacopeial requirements.
• Advanced technical writing skills, with demonstrated ability to author clear, defensible quality documents.
• High proficiency with quality systems and document management tools, including Veeva QualityDocs, Veeva QMS, Microsoft Sharepoint, and SmartSheet.
• Ability to manage multiple priorities in a fast-paced, development-stage environment.
• Strong collaboration and communication skills, with the confidence to challenge data when needed.