QA Compliance Manager – Contract
Adverum Biotechnologies
contract
Posted on:
Location Type: Hybrid
Location: Redwood City • California • United States
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Salary
💰 $60 - $69 per hour
About the role
- Support a wide variety of GxP activities to support Adverum’s quality compliance initiatives.
- Provide risk-based quality oversight to vendor qualification activities and ensure compliance with internal procedures and documentation.
- Create and manage vendor audit schedules. Conduct audits and interact with vendors to ensure compliance with internal requirements. Ensure vendor packages are complete and inspection ready.
- Assist with executing internal audits and maintaining the internal audit program and ensure compliance with quality objectives and regulatory requirements.
- Assist with regulatory inspections and oversee the inspection readiness plan. Support inspection readiness activities, as directed by QA management.
- Works closely with other functions to assure consistency and implementation of best practices.
- Foster a quality culture and compliance within the team, promoting teamwork, accountability, and continuous learning.
- Perform other responsibilities as assigned by QA management.
Requirements
- Direct auditing experience is required. Certified Quality Auditor certification is preferred.
- Bachelor’s degree in biological sciences or related field; Master’s degree preferred.
- 5-7 years progressive Quality Assurance and GxP compliance experience in pharmaceutical, biologics or advanced therapies;
- Extensive working knowledge and understanding of ICH, US FDA, EU and other relevant regulations.
- Ability to work and communicate effectively in a team environment with great organizational skills that enables risk-based quality management and a culture of quality and open dialogue.
- Possess effective interpersonal, verbal, and listening skills.
- Must be an individual with proven initiative, demonstrated accountability, and ability to manage multiple priorities in a fast-paced environment with high degree of flexibility.
- Ability to travel.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
auditingquality assuranceGxP compliancerisk-based quality managementvendor qualificationinternal auditsregulatory inspectionsinspection readinessdocumentation managementquality compliance
Soft Skills
teamworkaccountabilityorganizational skillsinterpersonal skillsverbal communicationlistening skillsinitiativeflexibilityopen dialoguecontinuous learning
Certifications
Certified Quality Auditor