Head of QA job in Crawley, England

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First Name*

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First Name*

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Job type: Permanent

Discipline: Senior/Director & VP

Location: United Kingdom

This vacancy has now expired. Please see similar roles below...

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.

Job Responsibilities

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.

To Apply

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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