BioSpace
Director, Quality Vendor Management & Compliance
Profoundly Improve People’s lives by Revolutionizing the Delivery of RNA Therapeutics 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). 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. 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 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 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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Profoundly Improve People’s lives by Revolutionizing the Delivery of RNA Therapeutics 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). 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. 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 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 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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