Head of Quality Assurance

Company: Aviceda
Location: Cambridge
Posted on: April 22, 2025

Job Description:

Overview:Aviceda is seeking a Head of GxP Quality to establish, lead, and oversee the company's Quality organization, ensuring compliance with GMP, GCP, and GLP requirements. This leadership role is essential in developing the company's Quality Management Systems (QMS), ensuring alignment with international regulatory standards, and driving initiatives that support the organization's strategic objectives. This newly created role will be responsible for establishing the internal Quality Assurance function, and will oversee all aspects of Quality Assurance, including GMP, GLP, and GCP compliance, document control, training, audits, vendor qualification, and regulatory submissions. The ideal candidate will be a strategic thinker with a hands-on approach and a proven track record of success in a similar role within a fast-paced biotech environment.The incumbent will work collaboratively across all functions with responsibilities for all aspects of Quality Assurance. The Quality Head is responsible for leading and managing all Aviceda Therapeutics Quality Assurance (QA) programs, activities, and staff to ensure compliance with global laws, regulations, and applicable guidance. The overall responsibility of this role is to design and execute strategic and tactical guidance for GxP (Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP)) and compliance for manufacturing, distribution, test laboratories, and clinical trial activities.Key Responsibilities

• Define and implement the organization's strategic quality vision, ensuring alignment with corporate goals.
• Establish a culture of quality at Aviceda.
• Provide strategic Quality input to support company objectives and milestones.
• Design, implement, and maintain robust GxP programs and frameworks, including QMS, SOPs, training programs, and issue management processes.
• Quality oversight of CDMOs and suppliers.
• Act as the primary point of contact with regulatory agencies and external auditors, fostering trust in the company's quality systems.
• Prepare for and lead regulatory inspections, ensuring compliance with applicable regulations and standards.
• Ensure the completion of scheduled third-party audits by internal QA staff or external contractors.
• Ensure that company and departmental SOPs, job descriptions, and training documentation are current, relevant, and appropriately maintained.
• Oversee the development, maintenance, and enhancement of processes, including Quality Event and CAPA management.
• Develop and execute risk-based audit strategies to ensure compliance with ICH/GCP guidelines and regulatory requirements.
• Identify and address process gaps or failures, implementing appropriate corrective actions.
• Promote a GxP-compliant culture across internal teams and external stakeholders.
• Provide expertise in interpreting and implementing regulations to assure compliance.
• Develop and analyze Quality-related metrics and provide actionable insights.
• Escalate GCP corporate risks, scientific misconduct, or noncompliance issues to resolution.
• Recruit, develop, and manage a high-performing, phase-appropriate Quality team.
• Foster a collaborative, innovative, and compliant work environment.Qualifications:
• Bachelor's degree in Science or related field; advanced degree preferred.
• At least 15 years of experience in the pharmaceutical or biotechnology industry, with significant expertise in Quality or a related function.
• Minimum of 8 years of Quality leadership/management experience in director or higher-level position.
• Strong knowledge of GxP and regulatory requirements, with hands-on experience implementing and managing Quality systems.
• Strong preference for hands-on experience building and implementing Quality Management System in a biotech startup company with clinical-stage portfolio.
• Strong organizational, analytical, and problem-solving skills, with the ability to manage multiple priorities in a dynamic environment.
• Proven ability to foster cross-functional collaboration and build relationships at all organizational levels.
• Superior team leadership, communication, collaboration, and problem-solving skills.
• Experience in all phases of regulatory submissions and interactions; international experience desired.
• Experience with documentation systems and with document review and auditing.
• Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards.
• Extensive experience handling health authority inspections.
• Small molecule drug development experience highly desirable.
• Experience in overseeing or participating in GMP audits and building a team for batch review and release.
• Experience in overseeing or participating in GCP audits; experience including external CRO, clinical/regulatory, and document auditing desirable.Aviceda Therapeutics is an equal opportunity employer offering competitive cash and stock compensation, excellent employee benefits, and the opportunity for personal and professional growth in an outstanding and intellectually challenging environment.
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Keywords: Aviceda, Boston , Head of Quality Assurance, Other , Cambridge, Massachusetts