Senior Manager, IT Compliance
Location: San Diego
Posted on: June 23, 2025
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Job Description:
Job Title: Senior Manager, IT Compliance Location: Hybrid
Position type: FLSA: Full time Exempt Department: Finance ID: IT
R&D 6402-J68197-BF 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 San Diego, CA 92121 O: 858-401-7900 F: 858-401-7901
Keywords: , Malibu , Senior Manager, IT Compliance, IT / Software / Systems , San Diego, California
