Associate Manager, QA Operations - AAV Manufacturing (2nd Shift)

The Associate Manager, Quality Assurance - AAV Manufacturing is responsible for the supervision and development of junior members of the Quality Assurance team and helping oversee AAV GMP manufacturing activities. The Associate Manager will provide expertise and guidance, ensuring compliance with regulatory requirements and maintaining the highest quality standards. The Associate Manager will supervise junior members of the Quality Assurance team in activities such as document control, batch record review, and maintaining a QA presence in AAV gene therapy manufacturing areas. The team works out of The Hearth, a 200,000-square-foot cGMP facility in Columbus, Ohio.

Responsibilities

Supervise and develop junior members of the Quality Assurance team; Help oversee AAV GMP manufacturing activities; Serve as a quality resource for the GMP AAV Manufacturing department, providing guidance and communication of Quality issues in the cleanroom manufacturing environment; Provide supervision for employee relations through communication, coaching, training and development; Assist management in setting clear vision and aligning goals with departmental objectives; Oversee timecard reporting, task oversight, and scheduling; Perform detailed review and approval of batch records, logbooks, and other controlled documentation; Collaborate with cross-functional teams including Process Development, Analytical Development, and Manufacturing to support continuous process improvement; Support documentation control, including creation, revision, review, and approval of batch records, SOPs, work instructions, and forms; Support deviations and continuous improvements, including root cause analysis and CAPA identification; Assist in preparation for external audits and inspections

Requirements

Bachelor's Degree (B.A. or B.S.) in scientific-related field or engineering (or equivalent work experience); 6+ years in a Quality Assurance or related role within the pharmaceutical or biotechnology industry; Experience mentoring and developing junior team members, including providing guidance on QA best practices and fostering professional growth; Thorough understanding of pharmaceutical cGMP requirements and strong working knowledge of FDA and EU requirements/guidance documents; Experience using an Electronic Quality Management System, preferably Veeva Vault or a comparable document management platform; Ability to collaborate with cross-functional technical groups to resolve issues, close gaps, and ensure compliant outcomes which are efficient and robust; Ability to manage competing priorities in a fast-paced, deadline-driven environment while maintaining accuracy, completeness, and compliance; Proficiency with Microsoft Office applications, including Outlook, Teams, Word, Excel, and PowerPoint; Ability to work the hours necessary to support production and participate in an on-call rotation providing off-hours support for AAV manufacturing needs and issues; Ability to work in a GMP cleanroom environment as needed, including wearing required PPE such as gowns, gloves, masks, and safety glasses

Nice to have

Direct experience in providing QA support for cGMP manufacturing operations in a cleanroom environment; Experience working in the production of biologics (ex. gene therapies); Familiarity with CDMO operations and client-driven project timelines; Experience supporting internal audits and participating in external audits or inspections

Benefits

Health, dental and vision insurance from day one with 90% of premiums covered for employee and family; Competitive paid time off plan; 12 weeks of fully paid parental leave; Annual bonus opportunities for full-time team members; 401(k) with company match; Special employee discounts, including childcare and dependent care savings; Onsite fitness facility at The Hearth; Mental health counseling and financial planning through Employee Assistance Program; Employer-paid short and long-term disability coverage; Fully stocked kitchen with free snacks and beverages; Ongoing professional development resources, training, and mentorship programs