Associate Director, Quality Assurance

Avidity Biosciences is pioneering a new class of oligonucleotide-based therapies called AOCs designed to overcome the current limitations of oligonucleotide therapies in order to treat a wide range of serious diseases. We utilize our proprietary AOC platform to design, engineer and develop therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) and the precision of oligonucleotide-based therapies to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases. We are passionate about the impact of every employee in bringing these potentially transformative therapeutics to patients in need. Make a difference with us.

The Associate Director, Quality Assurance, reporting to the Director, Quality Assurance, will be responsible for handling and managing QA oversight at Avidity’s contract manufacturing organizations (CMOs), quality systems, and batch disposition activities. This is a hands-on role and the candidate will be actively involved in providing QA oversight of Avidity cGMP activities at CMOs and ensuring compliance of established procedures and quality systems. The team member will collaborate cross-functionally with various departments within the organization and CMOs, and ensure effective communication and constructive working relationships with colleagues and business partners to enable global development of Avidity therapeutics.

• Develop, improve, and maintain quality management systems, policies, and SOPs
• Conduct review of manufacturing batch records and perform final product disposition
• Perform review and approval of Deviations, OOSs, Change Controls, CAPAs and any other related quality records
• Manage, track, and trend quality systems and establish metrics
• Support and review protocols and reports for Tech-Transfer, Qualification, and Validation activities
• Assist with implementation of QA process improvements
• Support inspection readiness
• Perform other duties as required

Qualifications

To perform this role successfully, an incumbent must be able to perform each essential duty satisfactorily. The preferred requirements listed below are representative of the skills, knowledge, and/or abilities required.  Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Preferred Education and/or Experience:

• Minimum Bachelor’s degree in a relevant scientific discipline or equivalent
• Minimum of 6 years of pharmaceutical industry experience in QA
• Extensive knowledge of GMP regulations, ICH Guidelines, FDA regulations and Guidance
• Good knowledge or experience in Aseptic processing
• Experience working with CMOs, vendor selection, and management
• Experience in conducting CMO audits is a plus
• Ability to work independently and in a cross-functional and collaborative environment
• Strong communication and interpersonal skills (maintain positive relationship and open communication)

• Ability to multi-task, shift priorities, and work in a fast-paced environment
• Detail oriented and well organized
• Team player, professional demeanor, enthusiastic, and self-motivated

• Experience in monoclonal antibodies and/or biologics is a plus

• Travel 10%, as required