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.
The Associate Director, GCP Quality Assurance, reporting to the Director of Quality Assurance, will manage the clinical quality function by supporting and providing oversight of clinical trials and clinical activities, establish and manage clinical quality systems, and ensure GCP compliance. The candidate will be hands-on and actively involved in executing GCP QA strategy, and support GCP compliance 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 with colleagues and business partners to enable global development of Avidity therapeutics.
Essential Duties and 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
- Perform other duties as required
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 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
Salary Range: $158,000 - $182,000 salary commensurate with experience