Associate Director, Analytical Quality Assurance

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, Analytical Quality Assurance, reporting to the Head of Quality Assurance, will be responsible for the quality oversight and management of GMP analytical-related activities and contracted testing laboratories. The candidate will be hands-on in ensuring compliance to applicable regulations and company’s policies and procedures and will support analytical activities at test labs across multiple contract sites. The position will work closely with CMC, regulatory affairs,  and other functional teams.

• Collaborate with internal and external analytical team in reviewing and approving analytical documentation
• Provide quality review of method development, qualification, validation, verification, and method transfer protocols and reports, including stability protocols and reports, and product specifications.
• Ensure data integrity of analytical testing and stability studies
• Review product release and stability data, as appropriate
• Conduct review of and provide input to laboratory investigations, including OOS, OOT, OOE investigations
• Manage and track documentation of analytical activities
• Contribute to CMO/laboratory selection, qualification, and audit, as required
• Identify compliance risks and implement risk mitigation, as applicable
• Support inspection readiness program and participate as needed
• 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 6 years of pharmaceutical industry experience and in a QA role
• Experience in GMP analytical development or quality control lab
• In-depth knowledge of FDA, EU, ICH requirements for GMP and related regulations and Guidance
• Experience in reviewing specifications, stability studies, method assays, method qualification and validation activities, including protocols and reports
• Experience working with CMOs and with vendor selection and management
• Implementing phase appropriate GMP quality systems in Phase 1-3
• Proven ability to thrive and enable success in a cross-functional and collaborative environment
• Strong communication, written, and interpersonal skills

• Ability to multi-task, shift priorities, work in a fast-paced environment, and problem-solving
• Detail oriented and well organized
• Team player, professional demeanor, enthusiastic, and self-motivated
• Travel 10-20%, as required

 
Salary Range: $158,000 - $182,000