Quality Assurance Manager
- Experience Level
My client, a growing Gene Therapy company in the King of Prussia area are currently looking to boost their Quality Assurance team with the appointment of a Quality Assurance Manager with a specialism in QMS, CAPA and Vendor Management.
Responsibilities and Experience required:
- Leading and managing QA’s day-to-day activities in support QMS with focus on the development, deployment, and management of the eQMS system (e.g., Deviations, CAPAs, Auditing, Change and Vendor Management, etc).
- Lead the QMS Program, specifically the deviation, CAPA, Audits, Vendor Management & change control programs.
- Develop, improve, and administer the QMS Program.
- Serve as Quality Events Champion. Monitor Quality Events, Deviations and CAPAs. Track and trend these and monitor CAPA effectiveness.
- Provide subject matter expertise to improve the QMS.
- Develop and improve Quality department procedures.
- Generate and monitor quality metrics to ensure on-time record closure and identify corrective actions. Development, implement, and report applicable quality metrics and KPIs.
- Develop and present QMS metrics to management, as required.
- Create best practices for authoring technical investigations, root cause analysis tools, and corrective and preventive actions.
- Deliver training to the whole organization on QMS topics, as needed.
- Support internal and external audits related to the QMS. Managing the internal audit schedule. This includes generation of reports and CAPAs and following up on all action items to ensure their timely closure.
- Monitor and schedule vendor qualifications. Ensure these are conducted according to schedule.
- Support the change management program by help drive change controls to completion
- Meet the minimum required years of experience in a related Biopharmaceutical QMS role
- Sr Manager – 10 years
- Assoc Director – 15 years
- Experience in Biopharmaceutical QA and/or Quality System improvement roles is preferred.
- A BA or BS is preferred though long-time experience in QA may be acceptable
- Gene therapy experience is a plus
- Strong organizational skills and attention to detail
- Strong interpersonal and communication skills
- Computer skills and previous experience with eQMS
- Ability to provide subject matter expertise regarding QMS implementation and administration
- Past experience managing complex projects is required.
- Ability to identify areas of improvement and provide solutions. Excellent technical writing and problem-solving skills.
- Ability to work effectively at a fast-paced environment with cross functional departments. This role requires the incumbent to be able to quickly adapt to changing priorities.
- Ability to work independently and with minimal supervision is required.
- Some travel may be required (~20%)
- MS Office proficiency
- Project Management experience
- Experience with Gene Therapy / Cell Therapy products
- Previous experience with MasterControl
- Entrepreneurial and results driven