Lead, QA Operations

Forge Biologics•Columbus, OH

10d•Onsite

About The Position

The Lead, Quality Assurance Operations is responsible for the supervision and development of junior members of the Quality Assurance team and helping oversee GMP manufacturing activities. The Lead will provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance. The Lead will supervise junior members of the Quality Assurance team in activities such as document control, review of laboratory data, deviation management, internal & external audits, and training.

Requirements

Bachelor’s Degree (B.A. or B.S.) in scientific-related field or engineering (or equivalent work experience).
6-8 years in a quality assurance 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.
Experience in supporting internal and external audits.
Thorough understanding of pharmaceutical cGMP requirements and strong working knowledge of FDA and EU requirements/guidance documents.
Direct experience in providing QA support for cGMP manufacturing operations.
Knowledge of drug development regulations such as the GCPs, GMPs and GLPs.
Proficiency in electronic quality management systems (eQMS) and document control software.
Strong analytical and problem-solving skills, with the ability to analyze complex quality-related data and propose effective solutions.
Ability to collaborate with diverse cross-functional technical groups to resolve issues, close gaps and ensure compliant outcomes which are efficient and robust.
Excellent communication skills, including the ability to effectively communicate quality issues to senior management.
Exceptional attention to detail and organizational skills to manage multiple priorities in a fast-paced environment.
Ability to work hours necessary to support production and/or product transfer activities.
Ability to work in confined spaces and near operating equipment.
Ability to work onsite (Columbus, Ohio) 5 days/week.
Ability to work in a cleanroom environment while wearing appropriate gowning and PPE.

Responsibilities

Serves as a quality resource for operations departments.
Responsible to make fact-based, scientifically and/or statistically sound, quality / regulatory compliant decisions regarding products.
Perform detailed review and approval of batch production records and associated documentation for AAV gene therapy manufacturing, ensuring adherence to established procedures and cGMP regulations.
Effectively communicate to management Quality issues that arise during the manufacturing of product.
Proactively identify and implement items to enhance quality through continuous improvement (CAPA).
Responsible for the leading, authoring, and reviewing of investigations, CAPAs and change controls to drive for resolution through root cause analysis.
Responsible for the review and approval of controlled documentation including Standard Operating Procedures (SOPs), Work Instructions, Forms, Methods, Batch Records, etc.
Develop and deliver comprehensive training programs to QA and manufacturing personnel on quality-related topics, ensuring proper understanding and adherence to AAV gene therapy manufacturing procedures and regulatory requirements.
Assist management in setting clear vision by ensuring goals and objectives are aligned with departmental goals and supervising each junior team member’s team support.
Oversee timecard reporting, task oversight, and scheduling as well as create and report metrics and internal KPIs.
Provide supervision for employee relations through effective communications, coaching, training and development and eliminate roadblocks for the team to move forward.
Supports regulatory audits as needed.

Benefits

Health from day one
Health, dental and vision insurance start your first day – with 90% of premiums covered for you and your family.
Time to recharge
A competitive paid time off plan – because rest fuels innovation.
12 weeks of fully paid parental leave so you can focus on family when it matters most.
Rewarding your impact
Annual bonus opportunities for all full-time team members.
401(k) with company match to help you plan for the future.
Special employee discounts, including childcare and dependent care savings.
Your wellness, supported
Onsite fitness facility at The Hearth.
Mental health counseling and financial planning services through our Employee Assistance Program.
Employer-paid short and long-term disability coverage to protect your peace of mind.
Fuel for your workday
A fully stocked kitchen with free snacks and beverages – we keep you energized and ready for what’s next.
Grow with us
Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.