Senior Director, Clinical Quality Assurance

4 weeks ago


San Diego, California, United States Avidity NanoMedicines Full time
Job Summary:

The Associate Director, GCP Quality Assurance, will play a key role in managing the clinical quality function by supporting and providing oversight of clinical trials and clinical activities. This individual will establish and manage clinical quality systems, ensuring GCP compliance and collaborating cross-functionally with various departments within the organization.

Responsibilities:

Develop, implement, and maintain GCP quality management systems, policies, and SOPs
Ensure GCP compliance of ongoing clinical trials
Conduct quality control reviews of clinical protocols, documents, and records, including regulatory filing
Identify compliance risks and implement risk mitigation, as applicable
Monitor, track, and trend GCP non-conformances, deviations, and CAPAs and communicate to management
Manage GCP audit activities, internal and external, including conducting clinical vendor qualifications and audits, conducting investigational site audits, and ensuring completion of corrective actions
Ensure clinical documentation in support of TMF is reviewed and archived appropriately
Support investigational product complaints and ensure compliance
Support inspection readiness of clinical programs

Requirements:

Minimum Bachelor's degree in a relevant scientific discipline or equivalent
Minimum of 6 years of pharmaceutical industry experience in GCP-QA
Extensive knowledge of GCP regulations, ICH Guidelines, FDA regulations and Guidance
Good working knowledge of GLP in support of non-clinical is recommended
Experience working with CROs, vendor selection, and management
QA experience in Phase 1-3 clinical trials
Proven ability to thrive and enable success in a cross-functional and collaborative environment
Strong communication and interpersonal skills
Ability to multi-task, shift priorities, and work in a fast-paced environment
Detail oriented and well organized
Team player, professional demeanor, enthusiastic, and self-motivated
Travel 10-20%, as required

Compensation Details:
We provide a reasonable range of compensation for this position. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location. The Pay Range for this position is $158,000- $182,000. It is possible that this position can be hired outside of this salary range based on experience.

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