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Director of Quality and Risk Management Full Time
4 months ago
Director , Quality Assurance, Validation
San Diego, CA / Hybrid / Remote
Full time
Regulatory Affairs and Quality Assurance
Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies . If you are a committed, solution-oriented thinker, join us in making a difference and be come part of our growing culture that is integrated, collaborative, agile and focused on the needs of patients .
Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare muscle diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Avidity is broadening the reach of AOCs with its advancing and expanding pipeline , including programs in cardiology and immunology through internal discovery efforts and key partnerships. Avidity is headquartered in San Diego, CA. For more information about our AOC platform, clinical development pipeline , and people, please visit and engage with us on LinkedIn and Twitter .
The D irector of Quality, validation will be responsible for supporting GMP validation activities and technical transfer, ensuring compliance , and that appropriate Quality Management Systems are established to support tech-transfer and validation work in accordance with regulations and industry standards . The individual will be the s ite Quality technical for tech-transfer and validation events, plan and design, and meeting regulatory requirements. Provide Quality Assurance oversight to tech-transfer and v alidation activities , and Q uality Risk Management projects to meet business practices and applicable Health Authorit y requirements . The individual should have a n unders tanding of technical principles and concepts in the field of validation and tech transfer.
Perform quality review and approve tech-transfer and validation deliverables ; Assist in planning and coordinating tech-transfer and validation schedule by working with stakeholders to ensure on time completion and compliance .
Support development projects, transfer projects, and process changes to provide overall guidance as it relates to quality standards and compliance.
Assist in the integration of the risk management program with quality systems including, but not limited to, tech-transfer and validation activities, including In spection Readiness.
Provide KPIs and metrics in support of quality management review.
10+ years of relevant work experience in the bio/pharmaceutical industries, including 5 years of quality tech-transfer and validation experience.
~ BS/MS degree in scientific discipline .
~ Knowledge of Risk Assessment Methodology .
~ Ability to manage multiple projects and tight timelines , including working independently and in a fast-paced environment.
~ Excellent communication, technical writing, critical thinking, and analytical skills.
~ Proficient with Microsoft Office MS Office (Excel, Word, PowerPoint), Adobe Acrobat, and eQMS , etc .
~ Ability to travel as required by projects (10-20% of time, US , and International) .
Avidity offers competitive compensation and benefits which includes the opportunity for annual and spot bonuses, stock options and RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off.
A commitment to learning and development which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.
