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Director/Senior Director Quality Systems/Assurance

Q32 BIO a Cambridge 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.

The Head of Quality Systems / Assurance will lead the continued development, execution, and communication of Q32 Bio’s quality strategy.  They will be responsible for translating the quality strategy into tactical policies, processes, and procedures to meet applicable global regulatory requirements and Q32’s standards.  This individual will ensure GxP compliance, identify and implement technology solutions to increase efficiency and promote innovation, as well as provide training and mentoring to cross-functional team members.  This position will report directly to the CMO.

RESPONSIBILITIES:

  • Oversee the Quality Management System (QMS) and ensure it meets standards expected by global regulatory authorities for research, development, and ultimately commercial activities
    • Establish, implement and monitor relevant QMS processes
    • Review and approve QMS documentation including controlled documents, training material, deviations, laboratory investigations, CAPAs and change controls
    • Lead SOP development, updates, and training
    • Develop and implement training programs to ensure compliance with GxP requirements
  • Ensure inspection readiness
  • Support/lead internal and external audits
  • Manage regulatory agency inspections by FDA and other regulatory agencies
  • Determine applicable quality standards and regulations and provide guidance and quality oversight to ensure ongoing compliance
  • Plan and oversee day-to-day activities of the Quality function including management of consultants/contractors/auditors
  • Establish strong working relationships with vendors (eg, CDMOs, CROs) and provide appropriate Quality oversight, including establishing vendor qualification processes, vendor audit plans, quality agreements and quality performance metrics
  • Provide quality support for tech transfers and GXP investigations
  • Establish and oversee the CAPA process and vendor management for quality issues
  • Oversee the selection, implementation or upgrading, and administration of electronic systems used to support GXP related activities
  • Keep abreast of industry developments, forthcoming regulations, guidance, best practices

Requirements

  • Bachelor’s degree with 12+ years of experience in the pharmaceutical/biopharmaceutical industry, including 8+ years of experience in a Quality role with increasing levels of responsibility
  • Thorough understanding of quality management systems and quality system design and practices in the pharmaceutical industry
  • Expert knowledge of GMP requirements and application, and experience with other GxPs (GLP, GCP, GDP)
  • Expertise managing vendor relationships (CMO, CRO)
  • Experience in establishing and managing cGMP quality systems (paper-based and electronic), including material disposition, Certificates of Analysis, stability monitoring and specifications
  • Strong analytical skills with practical knowledge of how to identify key performance quality metrics to set targets for maintaining a state of compliance, while identifying areas for improvement
  • Ability to streamline and revise processes to build in efficiencies
  • First-hand experience in regulatory inspections, including PAI
  • Experience managing and developing direct reports
  • Strong leadership, team building, organizational, communication, and interpersonal skills
  • Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient

 

Interested candidates should send their CV to talent@q32bio.com.