Head of QA
A large full service Contract Research Organisation is in search of a QA Manager to direct and lead the entire Quality Assurance program in both US and UK locations.
- Partners with internal and global external clients to manage a best-in-class GCP Quality Assurance (QA) program which enhances the organization's capabilities and continued growth.
- Oversees Quality Assurance team by providing guidance and direction to ensure departmental and client/project goals are met; coaches and develops team members.
- Manages the global GXP QA process and implements QA initiatives/audit programs, including IT QA projects, all of which lead to continuous improvement.
- Manages the corrective/preventive action plan (CAPA) process to ensure timely implementation of CAPAs, and escalation, as applicable.
- Conducts GXP audits of company systems, CRAs, clinical sites, external vendors and GMP audits as needed and ensures appropriate follow-up.
- Develops and leads audit /inspection readiness activities to ensure staff members are prepared to proactively participate in regulatory inspections and audits, and appropriately address outcomes.
- Assists in facilitation of client audits and regulatory inspections.
- Oversees quality system which provides guidance, tracking, and metrics of compliance.
- Oversees the SOP development process and compliance.
- Leads all training programs & initiatives while also administrating electronic training database
Skills and Requirements
- Minimum of a BA/BS in Science required.
- Advanced degree preferred.Prior experience leading GCP Quality Assurance programs and interfacing with the FDA & EMA.
- International and oncology experience preferred.
- Management experience, 7+ years in a CRO/pharmaceutical environment, is required.
- Effective ability to meet short- and long-term goals.
- Effective ability to anticipate challenges and to develop and implement solutions.
- Effective knowledge of MS Office computer skills.
- The ability and willingness to travel as required in the US and Internationally.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.