New · posted Oct 15
ADARx Pharmaceuticals · Biotechnology
Director, Clinical Quality Assurance
- San Diego, CA
- On-site
- Full-time
- Director
Open until filled
The role
We are seeking a motivated and qualified individual to join our team as Director, Clinical Quality Assurance. This role provides strategic and operational leadership for the Clinical QA function, ensuring the highest standards of Good Clinical Practice (GCP) compliance across all clinical programs. This role is responsible for building and maintaining a robust, risk-based quality framework that supports all stages of clinical development, regulatory submissions, and sustained inspection readiness. The role will serve as a key partner across functions, driving a culture of quality, compliance, and continuous improvement.
What you need
Required Key Attributes
- Strategic mindset with strong execution capability
- Deep expertise in GCP and clinical development processes
- High integrity and commitment to quality and compliance
- Strong leadership and stakeholder influence
- Solutions-oriented with a proactive, risk-based approach
- Understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders.
Travel Requirements
Approximately 10-20% travel may be required.
- Bachelor’s degree in life sciences, pharmacy, or related field; advanced degree preferred
- 12+ years of progressive GCP Quality Assurance experience in the biotechnology or pharmaceutical industry
- Direct experience supporting late-stage clinical trials (Phase 2/3) and NDA/MAA submission preparation, with proven inspection readiness experience
- Expert knowledge of global GCP regulations and guidance, including but not limited to:
- 21 CFR Parts 11, 50, 54, 56, 312
- EU Clinical Trial Regulation (EU-CTR)
- ICH E6(R2/R3), ICH E8
- General Data Protection Regulation (GDPR)
- Good Clinical Laboratory Practice (GCLP)
- Extensive experience leading GCP audits (internal, investigator sites, CROs, and vendors) and managing regulatory inspections
- Demonstrated ability to operate both strategically and hands-on in a small, fast-paced biotech environment
- Excellent communication, collaboration, and influencing skills across cross-functional teams
What you'll do
- Develop and execute the Clinical QA strategy aligned with organizational and development goals
- Develop, implement, maintain and continuously improve phase-appropriate, risk-based clinical. quality systems, processes, SOPs and policies to support early and late phase clinical trials and regulatory submissions.
- Implement proactive, risk-based approaches to identify, assess, and mitigate quality and compliance risks.
- Provide ongoing GCP quality oversight and support to ensure adherence to global GCP, quality and compliance requirements across all clinical programs.
- Partner closely with Clinical Operations, Clinical Development, Regulatory Affairs, Data Management, Biometrics, CMC, Clinical Supply Chain and study teams to proactively identify and mitigate compliance risks and ensure operational compliance.
- Provide Clinical QA oversight for CROs, laboratories, and other clinical vendors. Ensure appropriate qualification, monitoring, and oversight are in place.
- Review and contribute to key clinical and regulatory documents including INDs, protocols, IBs, NDAs, and other trial and submission-related materials, as applicable.
- Lead the planning and execution of a comprehensive, risk-based GCP audit program (investigator sites, CROs, vendors, and processes).
- Oversee the management of audit findings and drive effective CAPA implementation.
- Oversee and support investigations of deviations, noncompliance and quality events, ensuring thorough root cause analysis, CAPA implementation and proper documentation.
- Lead organizational inspection readiness activities for late phase programs and global regulatory authority inspections (e.g., FDA, EMA).
- Ensure systems are inspection-ready and aligned with evolving regulatory expectations.
- Serve as Clinical QA lead for regulatory inspections, including preparation, hosting, and post-inspection response management.
- Support NDA/BLA/MAA submission activities from a quality perspective.
- Influence and embed quality principles across the clinical development lifecycle.
- Develop and deliver annual GCP training programs and quality-related trainings.
- Communicate regulatory changes, best practices and compliance expectations to internal stakeholders.
- Collaborate closely with the broader Quality team to execute Quality objectives and ensure alignment across GxP areas.
- Foster a culture of inspection readiness and continuous improvement across the organization
Pay and benefits
ADARx Pharmaceuticals didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
- This is a full-time position, Monday-Friday, occasional overtime.
- Pay is commensurate with experience.
- Equity-based compensation
- Performance-based bonuses
- 401(k) with Company Match
- Medical, Dental, Vision
- Flexible Spending Account
- Life Insurance
- Employee Assistance Program
- Employee Discounts
- Gym Membership
- Paid Vacation
- Paid Holidays
- Paid Sick, Jury Duty, Bereavement
Equity-based compensation
Performance-based bonuses
401(k) with company match
Medical, dental, vision
Paid vacation and holidays
Gym membership
Where you'll work
San Diego, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in San Diego, CAWorking conditions
Work Authorization
- United States (Required)
- Background Check
- As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check.
ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
From the posting
About ADARx Pharmaceuticals
ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system.
Equal opportunity, accessibility and legal noticesADARx Pharmaceuticals's statements, word for word
Disclosure Statement
- The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
- Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
- The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law.
- Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses.
- Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.
Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
Director roles in California26 roles publishing pay
Director roles in the US102 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| California (middle half) | $197,500 | $213,500 | $241,000 |
| All US (middle half) | $186,500 | $209,250 | $231,375 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not ADARx Pharmaceuticals's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 34 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance20
- Collaboration and leadership11
- Regulatory submissions5
- Investigations and CAPA4
- Documentation and SOPs3
- Quality systems and risk3
- Lab testing and methods2
- Validation and qualification1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
- FDAFDA BLA(official source, opens in a new tab)Biologics License Applications
Company hiring pulse
ADARx Pharmaceuticals on Regulatory Jobs
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- Open roles
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Director, Clinical Quality Assurance at ADARx Pharmaceuticals
Open until filled.