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Affinia Therapeutics is a biotech company developing transformative gene therapies for cardiovascular and neurological diseases. We are backed by a strong syndicate of life science investors and have ambitious plans to have a dramatic impact on the lives of patients around the world. The pace of work is dynamic, fast and fun.

We are looking for a curious, organized and self-motivated individual to join our team at Affinia. Team members work together across functions towards a common cause.Ìý This is an excellent opportunity to gain experience and develop in a dynamic, next-generation gene therapy environment.

We offer competitive salary and benefits with the ability to make a difference.

Position Summary

The Senior Director/Vice President of Quality will lead the quality function and reports to the Chief Medical Officer. You will collaborate across functions to improve quality processes and will identify any risks on quality-related manufacturing problems. You will be responsible for quality oversight of Quality Assurance (QA), Quality Control (QC), CMC Technical Operations, Validation, and Clinical Operations.Ìý This role will lead Quality Control responsibilities regarding testing and release of products.Ìý You will be responsible for quality as it relates to our preclinical and clinical studies, including ensuring compliance with GxP processes and health authority guidance.Ìý In addition, you will provide leadership and direction for the successful implementation of the compliant quality systems and processes required for the development of gene therapy products by Affinia Therapeutics. Ìý

This position is located at the Affinia Therapeutics site in Waltham, MA with 4 days per week (M-Th) in the office.

Primary Responsibilities

• Lead the quality function in all GxP functional areas (GMP, GLP, GCP, document control, GxP training) from discovery through clinical development to launch readiness.
• Prepare quality metrics and performance indicators to measure and monitor performance of manufacturing process.
• Provide leadership and direction for the development and implementation of robust quality systems.
• Develop corporate and/or other organizational policies related to GxP compliance and oversee their implementation, including quality standards and SOPs.
• Provide strategic direction to implement global quality standards and procedures for GxP regulatory compliance.
• Oversee the planning and conduct of internal and external audits to ensure compliance with GxP regulatory requirements for clinical trials through commercial drug manufacturing as well as CRO audits in the preclinical space, as needed.
• Oversee quality issues, including deviations, CAPA, product complaints and ensuring regulatory compliance.
• Manage internal and regulatory agency inspections.
• Keep current on changes in industry and regulatory standards for GxP requirements and advise on business impact.
• Provide leadership to ensure the preparation of appropriate documentation for filing with regulatory bodies.
• Provide overall leadership with respect to recruiting, training, developing, and supervising staff to accomplish quality compliance and goals.

ÌýMinimum Qualifications

• Bachelor, Master or PhD degree in Life Sciences, Engineering or similar related disciplines
• 15+ years of related work experience, or equivalent combination of education and experience. Biotech experience preferred.
• At least 10 years of experience in positions of management responsibility within Quality Assurance.
• In-depth knowledge of FDA, EU and International regulations, compendial requirements and industry best practices regarding documentation systems, design control, change control, product specifications, and cGMP.
• Experience in AAV viral vector manufacturing preferred.
• Demonstrated, hands-on approach to building a successful quality organization in a startup environment.
• Substantial experience in leading and participating in regulatory inspections and preparing staff for regulatory inspections.
• Experience with documentation systems, document review and auditing responsibilities.
• Demonstrated ability in setting successful quality strategies and building and leading the quality function.
• Thorough understanding of industry regulatory environment related to quality systems.
• Strong organizational skills and the ability to participate effectively on cross-functional teams and across business unit lines.
• Ability to build consensus among colleagues with an appropriate level of flexibility, while maintaining a focus on results and goal attainment.
• Superb interpersonal, written communication and oral presentation skills.

ÌýEqual Opportunity Employer

ÌýAffinia is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity,Ìýnational origin, genetics, disability, age, sexual orientationÌýor veteran status.