Job Description
Adverum Biotechnologies, Inc., wholly owned subsidiary of Eli Lilly and Company is looking for a QA Compliance Manager to support ongoing GxP Quality Compliance activities such as Vendor Oversight, Internal Audits, Inspection Readiness, Operational Excellence and Regulatory Intelligence. This is a position within the Quality Assurance Team which requires collaboration with multiple internal and external stakeholders. Auditing experience is required. Strong problem solving, communication, and organizational skills are essential for an individual to be successful in this role. This position is hybrid with an expectation to be on-site at least 2 days a week.
Note to Recruiters and Agencies
All recruiter and agency inquiries must go through Adverum’s internal Talent Acquisition team. Unsolicited resumes sent to Adverum will be considered Adverum’s property. Adverum’s Talent Acquisition team must expressly engage agencies for any requisition. Direct contact with hiring managers by agencies will not be tolerated and may affect your ability to work with Adverum in the future.
What you’ll do:
- 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.
About you:
- 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
