Director, Quality Vendor Management & Compliance

Avidity Biosciences, Inc.; United States; On-site; USD 200,550 - 231,000; Full time

Benefits offered by this job

Annual and spot bonuses

Stock options and RSUs

401(k) with employer match

Education reimbursement program

Job summary

A biopharmaceutical company is seeking a Director of Quality Vendor Management & Compliance to oversee GxP vendor compliance and quality oversight. The ideal candidate will have over 10 years of experience in quality assurance and strong knowledge of regulatory standards. This position includes establishing vendor management metrics and conducting audits. A competitive salary and comprehensive benefits, including bonuses and stock options, will be offered.

Qualifications

• Minimum 10+ years of experience in biopharmaceutical quality assurance.
• Experience in conducting audits of contract service providers.
• Proven leadership in vendor quality responsibilities.

Responsibilities

• Oversee and manage quality and compliance of GxP vendors.
• Ensure vendors comply with regulatory requirements.
• Conduct and manage vendor qualification and audits.

Skills

Biopharmaceutical quality assurance

Leadership

Regulatory knowledge (FDA, EU, ICH)

Analytical thinking

Negotiation skills

Education

Bachelor’s degree in a scientific field

Advanced degree (MBA, MS preferred)

Job description

Director, Quality Vendor Management & Compliance

Avidity Biosciences, Inc. is 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 the company.

The successful candidate will be responsible for providing quality oversight, vendor management compliance processes, and continuous improvement initiatives. 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
• 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

Avidity Biosciences, Inc. is an equal opportunity employer and welcomes applications from diverse candidates.