BioSpace
Director, Quality Vendor Management & Compliance
Profoundly Improve People’s Lives by Revolutionizing the Delivery of RNA Therapeutics
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 X.
The Opportunity
We are seeking a dynamic and experienced Director of Quality Vendor Management & Compliance to lead and oversee compliance of GxP vendors in providing services and products to Avidity Biosciences, Inc. This role is critical in ensuring vendors comply with applicable regulations, regulatory requirements, and established service and quality agreements. The role is responsible for providing quality oversight, vendor management compliance processes, and continuous improvement initiatives. The candidate will be tactical and provide strategic leadership plans for highest quality standards. The position requires effective cross‑functional communication and strong professional presence interfacing with internal and external stakeholders.
What You Will Contribute
Oversee and manage the quality and compliance of GxP vendors
Establish vendor monitoring and management compliance metrics / KPIs and scorecards
Assign and maintain vendor risk classification
Establish vendor audit schedule and maintain Approved Vendor List
Conduct and manage vendor qualification and audits, maintain audit records and certificates, and update audit logs and files
Identify gaps and compliance issues and establish risk assessment and mitigation plans for high‑risk vendors
Support continuous improvement initiatives for the supplier management program
Contribute to vendor selection process and performance governance.
Manage vendor quality agreements including review, negotiate, and approve contract service provider agreements and implementing initiatives to improve quality agreements and vendor management processes
Establish and update SOPs in support of vendor management and compliance quality systems
Support other tasks or assignments as needed
What We Seek
Bachelor’s degree in a scientific field; advanced degree (MBA, MS or equivalent preferred)
Minimum 10+ years of experience in biopharmaceutical quality assurance
Experience in conducting audits of contract service providers
Experience in managing and reviewing quality and service agreements, including strong skills in identifying gaps and achieving alignment
Proven leadership in leading vendor quality responsibilities and ensuring compliance
Strong understanding and knowledge of global regulatory and quality standards and regulations (e.g., FDA, EU, ICH)
Ability to work collaboratively, team building, and drive strategic initiatives
Excellent leadership, communication, attention to detail, well organized, and negotiation skills
Analytical thinking, effective decision‑making with data‑driven approach, and problem‑solving skills
Flexible to work in a fast‑paced, dynamic environment, and evolving priorities
Open to travel 25% as needed
What We Will Provide To You
The base salary range for this role is $200,550 - $231,000. 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 include 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.
Additional Details
Title: Director, Quality Vendor Management & Compliance
Location: Hybrid
Position Type: Full time / Exempt
Department: Quality Assurance
ID: 8300-Q224-18
#J-18808-Ljbffr
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 X.
The Opportunity
We are seeking a dynamic and experienced Director of Quality Vendor Management & Compliance to lead and oversee compliance of GxP vendors in providing services and products to Avidity Biosciences, Inc. This role is critical in ensuring vendors comply with applicable regulations, regulatory requirements, and established service and quality agreements. The role is responsible for providing quality oversight, vendor management compliance processes, and continuous improvement initiatives. The candidate will be tactical and provide strategic leadership plans for highest quality standards. The position requires effective cross‑functional communication and strong professional presence interfacing with internal and external stakeholders.
What You Will Contribute
Oversee and manage the quality and compliance of GxP vendors
Establish vendor monitoring and management compliance metrics / KPIs and scorecards
Assign and maintain vendor risk classification
Establish vendor audit schedule and maintain Approved Vendor List
Conduct and manage vendor qualification and audits, maintain audit records and certificates, and update audit logs and files
Identify gaps and compliance issues and establish risk assessment and mitigation plans for high‑risk vendors
Support continuous improvement initiatives for the supplier management program
Contribute to vendor selection process and performance governance.
Manage vendor quality agreements including review, negotiate, and approve contract service provider agreements and implementing initiatives to improve quality agreements and vendor management processes
Establish and update SOPs in support of vendor management and compliance quality systems
Support other tasks or assignments as needed
What We Seek
Bachelor’s degree in a scientific field; advanced degree (MBA, MS or equivalent preferred)
Minimum 10+ years of experience in biopharmaceutical quality assurance
Experience in conducting audits of contract service providers
Experience in managing and reviewing quality and service agreements, including strong skills in identifying gaps and achieving alignment
Proven leadership in leading vendor quality responsibilities and ensuring compliance
Strong understanding and knowledge of global regulatory and quality standards and regulations (e.g., FDA, EU, ICH)
Ability to work collaboratively, team building, and drive strategic initiatives
Excellent leadership, communication, attention to detail, well organized, and negotiation skills
Analytical thinking, effective decision‑making with data‑driven approach, and problem‑solving skills
Flexible to work in a fast‑paced, dynamic environment, and evolving priorities
Open to travel 25% as needed
What We Will Provide To You
The base salary range for this role is $200,550 - $231,000. 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 include 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.
Additional Details
Title: Director, Quality Vendor Management & Compliance
Location: Hybrid
Position Type: Full time / Exempt
Department: Quality Assurance
ID: 8300-Q224-18
#J-18808-Ljbffr