Director, Gcp Quality Assurance

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Job Title:

Director, GCP Quality Assurance

Location:

San Diego, CA (or Remote)

Position type:

FLSA:

Full time

Exempt

Department:

Regulatory and Quality Assurance

Salary Range: 

$207K - $225K

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Company Overview

Avidity Biosciences is pioneering a new class of oligonucleotide-based therapies called AOCs designed to overcome the current limitations of oligonucleotide therapies in order to treat a wide range of serious diseases. We utilize our proprietary AOC platform to design, engineer and develop therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) and the precision of oligonucleotide-based therapies in order to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases. We are passionate about the impact of every employee in bringing these potentially transformative therapeutics to patients in need. Make a difference with us.

Job Summary

 

The Director, GCP Quality Assurance, reporting to the Head of Quality Assurance, will oversee and manage clinical quality systems and ensure compliance of clinical trials by providing support and oversight of clinical activities. The candidate will support and develop applicable SOPs in support of clinical trials, Phase 1-III global clinical studies. This is a hands-on and actively involved in executing GCP QA strategy, and support and alliance activities with vendors and business partners. The personnel will collaborate cross-functionally with various departments within the organization, and ensure effective communication and constructive working relationships to enable global development of Avidity therapeutics.

Essential Duties and Responsibilities

• Provide GCP QA support for clinical development and operation activities
• 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
• Compile and analyze audit metrics and generate data report
• 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
• Perform other duties as required

 

Qualifications

 

To perform this role successfully, the candidate must be able to perform each essential duty satisfactorily. The preferred requirements listed below are representative of the skills, knowledge, and/or abilities required.  Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

 

Preferred Education and/or Experience

 

• Minimum Bachelor’s degree in a relevant scientific discipline or equivalent
• Minimum of 10 years of pharmaceutical industry experience in GCP-QA
• Extensive knowledge of GCP regulations, ICH Guidelines, FDA regulations and Guidance
• Good working knowledge of GVP and GLP in support of non-clinical is recommended
• Experience working with CROs, vendor selection, and management
• Audit experience of CROs, central labs, vendors, and clinical study sites
• Experience with eTMF and eQMS
• QA experience in Phase 1-3 clinical trials
• Experience in regulatory inspection readiness and regulatory inspections
• Proven ability to thrive and enable success in a cross-functional and collaborative environment
• Strong communication and interpersonal skills
• Experience in developing and implementing quality systems and risk management tools
• Attention to detail and evaluate and troubleshoot problems
• Ability to multi-task, shift priorities, and work in a fast-paced environment
• Experience managing direct reports, coaching, and career development
• Team player, professional demeanor, enthusiastic, and self-motivated
• Travel 10-20%, as required