Senior Manager, IT Compliance

California Jobs; San Diego (CA); On-site; USD 166,000 - 184,000; Full time

Job summary

Avidity Biosciences is seeking a Senior Manager, IT Compliance, to lead the evolution of their IT compliance program. This role focuses on embedding compliance across IT systems and ensuring audit readiness as the company transitions into a commercial entity. Ideal candidates will utilize modern compliance strategies and play a critical role in the biotechnology sector.

Benefits

401(k) with employer match

Comprehensive wellness program

Education reimbursement program

Stock options and RSUs

Opportunity for annual and spot bonuses

Four weeks of time off

Qualifications

• 4+ years managing a team or program in IT compliance.
• Experience in a biotech or regulated life sciences environment.
• Strong knowledge of GAMP 5 and 21 CFR Part 11.

Responsibilities

• Architect and implement a modern IT compliance framework.
• Ensure regulatory alignment and audit readiness.
• Integrate compliance with agile development practices.

Skills

Leadership

Risk Management

Agile Practices

Compliance Strategy

Communication

Education

Bachelor's degree in Information Technology, Life Sciences, or related field

Job description

Profoundly Improve People's lives by Revolutionizing the Delivery of RNA Therapeutics

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). 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 www.aviditybiosciences.com and engage with us on LinkedIn and X.

We are seeking a Senior Manager, IT Compliance to lead the evolution of our IT compliance program as we transition from a development-stage biotech company to a fully commercial organization. This role is ideal for a forward-thinking compliance leader who embraces Computer Software Assurance (CSA) principles and modern, risk-based validation practices over traditional CSV approaches.

You will be instrumental in embedding compliance across IT systems, SaaS platforms, and regulated lab and commercial applications, and ensuring audit readiness.

What You Will Contribute

• Champion CSA & Risk-Based Compliance: Architect and implement a modern IT compliance framework centered on CSA, risk-based decision-making, and automation. Replace documentation-heavy validation with streamlined, value-focused approaches.
• Promote Agile Validation: Integrate compliance with agile development practices. Use tools such as automated testing and AI to drive efficiency, reduce manual effort, and increase confidence in system performance.
• Ensure Regulatory Alignment Without Overhead: Ensure IT systems supporting GxP and regulated activities comply with GAMP 5 (2nd Edition), 21 CFR Part 11, EU Annex 11, Data Integrity, and other life science requirements without reverting to traditional, burdensome validation models.
• Audit & Inspection Readiness: Drive preparation for internal audits, pre-approval inspections (PAIs), and third-party assessments with lean, risk-prioritized evidence.
• Policy & SOP Leadership: Author and maintain modernized IT policies and SOPs reflecting CSA philosophy focused on product quality, data integrity, and system performance, not just documentation.
• Risk Management & Continuous Improvement: Continuously assess IT compliance risks and lead targeted mitigation efforts. Champion continuous improvement and adaptive compliance practices.
• Enable Compliance by Design: Partner with cross-functional teams (Quality, Legal, InfoSec, Business Systems) to embed compliance into systems from the start, not as an afterthought.
• Third-Party Oversight: Drive efficient, risk-based assessments of SaaS vendors, CROs, and technology partners, ensuring they meet compliance expectations without unnecessary complexity.
• Education & Culture: Design role-specific, risk-aware training that fosters a culture of smart compliance across functions like R&D, Clinical, Commercial, and IT.

What We Seek

• Bachelor's degree or equivalent experience in Information Technology, Life Sciences, or a related field.
• 4+ years' experience managing a team, process, program or functional area within IT compliance, audit, or risk management. Experience in a biotech, pharmaceutical, or regulated life sciences environment is required.
• Demonstrated experience applying CSA and risk-based IT compliance strategies in a life sciences environment.
• Proven impact on IT compliance programs during a commercial launch or PAI is strongly preferred.
• Strong working knowledge of GAMP 5 (especially CSA updates), 21 CFR Part 11, GxP, and other life science regulatory frameworks.
• Demonstrated success leading system validation and compliance in preparation for commercialization or launch.
• Strong understanding of IT system lifecycle management in regulated environments.
• Excellent communication and stakeholder engagement skills.

What We Will Provide To You

• The base salary range for this role is $166,250 - $183,750. 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 include 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

92121

O: 858-###-####

F: 858-###-####

About the company

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