Director of Quality Systems and Compliance
1 week ago
At Avidity Biosciences, we are seeking a highly skilled and experienced Director, Quality Systems and Compliance to join our Regulatory and Quality Assurance team. As a key member of our organization, you will be responsible for ensuring the quality of our products and services, while also ensuring compliance with regulatory requirements.
Key Responsibilities:- Develop, implement, and maintain quality management systems, policies, and procedures to ensure compliance with regulatory requirements.
- Lead the quality systems changes, new initiatives, and process improvements 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, including 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.
- 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%.
- 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.
- 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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San Diego, California, United States Avidity Biosciences Full timeAbout Avidity BiosciencesAvidity Biosciences is a pioneering biotechnology company that is revolutionizing the field of oligonucleotide-based therapies. Our mission is to develop innovative treatments for a wide range of serious diseases, and we are passionate about the impact that every employee can make in bringing these potentially transformative...
