Director, Quality Systems and Compliance

Company: Avidity Biosciences, Inc.
Location: San Diego
Posted on: November 16, 2024

Job Description:

Job Title: Director, Quality Systems and ComplianceLocation: San Diego, CA / Hybrid / RemotePosition type: Full timeFLSA: ExemptDepartment: Regulatory and Quality AssuranceStrive to Bring a Profound Difference to our PatientsAt 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.The OpportunityThe Director, Quality Systems and Compliance is a senior leader accountable for the quality oversight and compliance support of the GxP quality systems and ensuring continuous process improvement within the Quality Assurance department. This position will also be responsible for the management and support of inspection readiness program. The candidate will be hands-on and strategic for ensuring the quality systems, enable and facilitate compliance with applicable regulations (FDA, EU and other countries) and company's policies and procedures.What You Will Contribute

• Develop, improve, and implement risk-based and appropriate quality management systems, policies, and procedures in support of GxP work.
• Lead the quality systems changes, new initiatives, and process improvement to support evolving regulations and international standards.
• Ensure regulation compliance of quality systems across GxP activities including review and approval of quality documents and continuous improvement.
• Collaborate with cross-functional teams to ensure alignment on quality objectives and priorities.
• Establish and manage the performance and effectiveness of quality systems and processes; SOPs, deviations, CAPA, change control, investigations, audits, and training.
• Develop quality metrics, including trending and reporting data for Management Reviews.
• Collaborate with internal and external teams in addressing quality compliance events and proactively identify and mitigate issues.
• Support the implementation of electronic QMS.
• Identify compliance risks and implement risk mitigation plans to enable innovative solutions.
• Develop inspection readiness program, mock inspections, and support and participate in regulatory authority inspections.
• Establish or support Quality Agreements with applicable contractors.
• Support GxP vendor qualification activities and audit program.
• Perform other duties as required.What We Seek
  • Minimum a bachelor's degree in a relevant scientific discipline or equivalent.
  • Minimum of 10 years of pharmaceutical industry experience in QA with extensive knowledge of Quality Management Systems.
  • Exhibit leadership conduct with high standards, professionalism, and ethics.
  • Implementing phase appropriate and commercial quality systems.
  • In-depth knowledge of GxP regulations and Guidance (FDA, EU, ICH).
  • Experience in regulatory inspections and inspection readiness.
  • Experience working with Contract Service Organizations.
  • Proven ability to thrive and enable success in a cross-functional and collaborative environment.
  • Ability to multi-task, shift priorities, work in a fast-paced environment, and problem-solving.
  • Detail oriented, well organized, and strong project management skills.
  • 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 10%.What We will Provide to You:
    • The base salary range for this role is $196,900 - $217,500. 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.
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