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Associate Director / Director Quality Control and Quality Assurance – Analytical Development and CMC Process development

Q32 BIO a Cambridge, MA based biotechnology company, is advancing novel therapeutics to treat autoimmune and inflammatory disorders. We aim to deliver life-changing treatments for patients with a variety of diseases for whom no adequate treatment options exist.

As our company moves to later stages of development and expands our clinical programs, we are looking for a Director of Quality Control and Quality Assurance for Analytical Process Development. We are looking for someone that can develop a cohesive Quality Control strategy, and Quality assurance plan to provide support to CMC process development by rolling up their sleeves and executing on those plans.

Position Summary:

Reporting to Vice president of Quality, this position will lead Quality control and analytical process development program at Q32 Bio. This lead position is expected to work closely with the internal non-clinical, clinical and CMC teams and liaise with contract manufacturers and contract labs as Q32 bio’s QC program lead and a primary point of contact for all QC activities.

  • Assist CMC team by overseeing our two lead assets ADX-097 and ADX-914 Quality control and analytical process development process. Enable continuous improvement to analytical processes, and standards by supporting the CMC team, to be ready for Phase 2.
  • Development and implement streamlined policies, procedures and systems and careful utilization of external partners for all QC testing functions. Assess test results and recommend changes.
  • Be involved in Quality assurance, improve process and procedures to identify deviations from quality standards and suggest improvements. Be responsible for helping CMC to set up methods, qualification and transfer and specifications.
  • Be responsible for test report reviews and finalization, inspecting the final output, comparing it to the requirements, and approving or rejecting the final products. Keep accurate documentation and performing statistical analysis.
  • Work closely with CMC team and external partners to improve the Phase 2 method qualification process, ensure higher-quality methods, work to develop new specifications and procedures for products or processes, and training CMC and bioanalytical on setting the requirements for raw materials from suppliers and monitoring their compliance.
  • Providing guidance to ensure legal obligations are followed and ensuring compliance with regulatory bodies and with health and safety guidelines.
  • Gain feedback from the Contract manufacturers, attending contractor meetings, submitting reports, and assisting internal and external processes, updates, and communication.

Core Responsibilities:

  • Collaborate with management across functions (CMC, Clinical development and non-clinical) to draft and communicate phase appropriate acceptable quality standards.
  • Development and implement policies, procedures and systems and careful utilization of external partners for all QC testing functions.
  • Be responsible for working closely with CRO on optimization of current assays and validation of new assays for new and/or existing products as necessary. Work with CMOs or third-party vendors to ensure that any required QC technical transfers occur in a compliant and efficient manner. Work with internal stakeholders and external contract labs to ensure that inspection and testing methods are qualified and transferred according to the plan.
  • Develop and implements quality standard testing and evaluation processes. Facilitate communication among production divisions and management. Ensure vendor oversight to ensure technicians/analysts are trained and qualified as required for performance of his/her job function.
  • Develop, implement, and periodically evaluate program to ensure the vendor QC operations, from raw materials to finished products, meet the quality, integrity, and efficiency standards set by the organization.
  • Manage all outsourced Quality Control functions, including lot release testing, stability testing, protocol and research testing, and investigational testing. Work with vendors to ensure that all testing is prioritized, scheduled, and executed in a timely and efficient manner.
  • Periodically report status of quality control and operations to executive leadership and, when required, regulatory agencies. Assess test results and approve recommended changes.

Required Education and Experience:

  • Minimum B.S. in scientific discipline or related field. Advanced degree preferred.
  • Significant quality control laboratory, technical operations, and management experience, 10 – 15 years within a biopharmaceutical or biotech company.
  • Strong analytical problem-solving experience essential. Demonstrated ability to troubleshoot and resolve complex technical problems.
  • Excellent management, interpersonal and communication skills. Strong verbal and written communication skills are essential. Excellent organization and multi-tasking skills.
  • Strong understanding of GxPs. Ability to facilitate change in a fast-paced organization and manage systems and tasks efficiently.

Interested applicants should send inquiries and CV to