Manager, Quality Control

Role Summary

The Manager of Quality Control is a strategic and tactical quality professional responsible for overseeing and executing all aspects of commercial GMP-related analytical testing and late-stage GMP development testing. This includes oversight of contract laboratories and testing performed by manufacturers for commercial and late-stage products, starting materials, in-process, release, and stability testing throughout the product lifecycle, as well as assembling, reviewing, and trending release, IPC, and stability data.

The role supports method transfers, method validation, and QC data integrity for late-phase development and commercial programs.

• Lead and assist in identifying changes to processes and their impact on product quality and established procedures.
• Review, assemble and trend release, IPC, and stability data, generating reports as necessary.
• Handles contract laboratory vendors, supervises laboratory performance, assesses capability, and ensures corrective actions when needed.
• Point person for weekly communications with external labs for status updates and testing activities.
• Measure performance against established KPIs to ensure timely and accurate testing, reporting, and release.
• Ensure all Out of Specification / Out of Trend results are thoroughly investigated with root cause identified and corrective actions implemented.
• Handle method transfer, method development and validation activities at external lab sites.
• Cross-functional liaison working closely with internal collaborators.
• Statistical programming and data management support is a plus.
• Develop statistical analysis plans as needed, including derived data sets and templates for statistical tables, figures, data listings, and graphs for clinical summary reports.
• Provide mentorship, support, and training to internal/external staff as needed.

• Required:
  
  BS/BA or equivalent in a science or healthcare field with a preferred focus on chemistry, biochemistry, microbiology, physics; minimum 5+ years in the pharmaceutical industry with a GMP testing focus, ideally covering the analytical method and testing lifecycle from development through commercial drug product testing.
• Preferred:
  Knowledge of QC processes and GMP regulations with demonstrated efficiency in maintaining QC processes for regulatory compliance.
• Preferred:
  Expertise in method verification and validation procedures.
• Preferred:
  Knowledge of statistical programming.
• Preferred:
  Experience in API manufacturing and process chemistry.
• Preferred:
  Excellent presentation skills (verbal and written).
• Preferred:
  Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Preferred:
  Ability to establish and maintain collaborative working relationships with internal and external partners.
• Preferred:
  Ability to take initiative and work independently while meeting timelines.

• BS/BA or equivalent in a science or healthcare field; preferred focus in chemistry, biochemistry, microbiology, physics.

• GMP quality systems and regulatory awareness
• Analytical method verification and validation
• Statistical programming (preferred)
• Data analysis and reporting
• Communication and mentorship