QA Compliance Manager

Adverum(whollyownedsubsidiaryof

Eli Lillyand Company ) islookingfora

QA Compliance Managertosupportongoing Gx PQuality Complianceactivitiessuchas Vendor Oversight ,Internal Audits,Inspection Readiness,Operational Excellence and Regulatory Intelligence .Thisisapositionwithinthe Quality Assurance Teamwhichrequirescollaborationwithmultipleinternalandexternalstakeholders .Auditingexperienceisrequired.

Strong problem solving,communication,andorganizationalskillsareessentialforanindividualtobesuccessfulinthisrole.

Thispositionishybridwithanexpectationtobeon-siteatleast2daysaweek.

• 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.

• 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.

$60 - $69 an hour