Manager, Quality Assurance

Job Title:

Manager, Quality Assurance

Location:

Hybrid / Remote

Position type:

FLSA:

Full time

Exempt

Department:

Regulatory and Quality Assurance

Strive to Bring a Profound Difference to our Patients

At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people's lives by delivering a new class of RNA therapeutics. Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. If you are a committed, solution-oriented thinker, join us in making a difference and become part of our growing culture that is integrated, collaborative, agile and focused on the needs of patients.

Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs). Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare muscle diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Avidity is broadening the reach of AOCs with its advancing and expanding pipeline, including programs in cardiology and immunology through internal discovery efforts and key partnerships. Avidity is headquartered in San Diego, CA. For more information about our AOC platform, clinical development pipeline, and people, please visit www.aviditybiosciences.com and engage with us on LinkedIn and Twitter.

The Opportunity

The Manager, Quality Assurance, reporting to the Director, Quality Assurance, will be responsible for handling and managing QA oversight at Avidity's CMOs, quality systems, and batch disposition activities. This is a hands-on role and the candidate will be actively involved in providing QA oversight of Avidity cGMP activities at CMOs and ensuring compliance of established procedures and quality systems. The team member will collaborate cross-functionally with various departments within the organization and contract manufacturing organizations/CMOs and ensure effective communication and constructive working relationships with colleagues and business partners to enable global development of Avidity therapeutics.

What You Will Contribute

• Conduct review of manufacturing batch records and perform final product disposition

• Perform review and approval of Deviations, OOSs, Change Controls, CAPAs and any other related quality records

• Review and approve CMO documentation

• Support and review protocols and reports for Tech-Transfer, Qualification, and Validation activities

• Assist with implementation of QA process improvements

• Perform other duties as required

What We Seek

• Minimum Bachelor's degree in a relevant scientific discipline or equivalent

• Minimum of 5 years of pharmaceutical industry experience in QA

• Extensive knowledge of GMP regulations, ICH Guidelines, FDA regulations and Guidance

• Experience working with CMOs, vendor selection, and management

• Experience in monoclonal antibodies and/or biologics is a plus

• Good knowledge or experience in Aseptic processing

• Ability to work independently and in a cross-functional and collaborative environment

• Strong communication and interpersonal skills (maintain positive relationship and open communication)

• 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

• Team leadership experience within a cross-functional matrix environment

• Demonstrated excellent communication (oral and written), teamwork, organizational, interpersonal, and problem-solving skills

• Ability to travel as needed for up to 10% of the time

What We will Provide to You:

• The base salary range for this role is $132,100 - $146,100. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.

• Avidity offers competitive compensation and benefits which includes the opportunity for annual and spot bonuses, stock options and RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off.

• A commitment to learning and development which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.

Avidity Biosciences

10578 Science Center Dr. Suite 125

San Diego, CA

92121

O: 858-401-7900

F: 858-401-7901