QA Associate Director, Process Validation

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Job description

Job Title:

QA Associate Director, Process Validation

Location:

San Diego, CA / Hybrid / Remote

Position type:

FLSA:

Full time

Exempt

Department:

Quality Assurance

Strive to Bring a Profound Difference to our Patients At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people's lives by delivering a new class of RNA therapeutics. 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 become part of our growing culture that is integrated, collaborative, agile and focused on the needs of patients.

Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs ). 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 Opportunity

The Associate Director of Quality Assurance, Process Validation will be responsible for supporting GMP process validation and development activities, ensuring that appropriate validation considerations are made early in the development process to support tech-transfer and validation work in accordance with regulations and industry standards. The individual will be a subject matter expert for process validation documentation, and support all stages of the process validation process. Provide Quality Assurance support to tech-transfer and process validation activities, and participate in Quality Risk Management assessments. This is a multidisciplinary role and the individual will interface with internal and external stakeholders. The individual should have an understanding and working knowledge of technical principles and concepts in the field of process validation and tech transfer.

What You Will Contribute

• Work with cross-functional teams to collaborate, develop, and approve design and development aspects of process validation and product specific process validation plans.
• Support new product introduction, tech transfer, and process and analytical qualification and validation activities.
• Perform quality review and approve tech-transfer and validation deliverables; including VMP, tech-transfer plans, validation protocols and reports, MBRs, EBRs, and study design and execution documents, and ensure compliance.
• Work to ensure on-time completion of approved validation schedules by working with internal stakeholders and external partners to maintain timelines and ensure successful completion and compliance.
• Support the introduction of new products by acting as QA validation SME for development projects, transfer projects, and process changes to provide overall guidance as it relates to quality standards and compliance.
• Provide support to applicable investigations, Deviations, CAPAs, and change control for the GMP system related to tech-transfer and validation.
• Assist in developing a risk-based approach to manufacturing process monitoring/process improvement programs for Avidity products which will ensure continued compliance and inspection readiness.
• Assist in providing data and assessing metrics in support of quality management review.

What We Seek

• 8+ years of relevant work experience in the bio/pharmaceutical industries, including 4 years of process validation experience.
• BS/MS degree in scientific discipline.
• In-depth working knowledge of the FDA Process Validation guidance, and expertise in all stages of process validation concepts in FDA regulated industries.
• Knowledge of Risk Assessment performance and ability to perform risk-based validation.
• Ability to build professional relationships with internal stakeholders and CMOs.
• 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.
• Excellent organizational, prioritization, problem solving, and sound decision-making 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).

What We will Provide to You:

• The base salary range for this role is $167,600 - $185,200. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.
• 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.

Avidity Biosciences

10578 Science Center Dr. Suite 125

San Diego, CA

92121

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