Quality Assurance Director

Established, Successful Pharmaceutical Manufacturers are Seeking to Add an Experienced Quality Assurance Director, (QAD), to the Leadership Team

The QAD will Report to the Chief Operating Officer and Will Work Closely with the Senior Management Team to Direct and Implement Strategies Across the Business to Ensure Compliance with Pharma Regulations

The QAD is Responsible for Overseeing the Qualified Persons and Operational Quality Assurance Activities to Ensure Timely and Compliant Product Release/Batch Release in Accordance with Current Good Manufacturing Practice (cGMP) and Good Distribution Practice (cGDP)

In Addition to the Batch Release Process, The QAD is Responsible for Ensuring Overall Site Compliance with the Established Quality Management Systems (QMS)

The QAD is Responsible for Managing All Quality Assurance Functions, and Working with Cross‐Departmental Leadership to Deliver High Quality Products, On Schedule and Promote a Quality Mind‐Set Across the Entire Company

ROLE (Key Responsibilities Include)

• Manage a Team of Qualified Persons, Responsible for Supporting the GMP‐Compliant Batch Certification and Release Process
• Ensure the Performance of Regular Product Quality Reviews is Carried Out by the QA and QP Groups
• Oversee and Manage the Operational Quality Assurance Team who Support Contract Manufacturing and Contract Laboratory Activities
• Facilitate Innovation and Continual Improvement of the Product Throughout its Lifecycle
• Ensure Effective Management and Continuous Improvement of the Quality Management System (QMS), Including Completing Management Reviews, CAPAs, Change Controls, Deviations, Internal/External Auditing and Project Management
• Represent QA in High‐Level Product Launch and Commercialisation Meetings
• Quality Authority and Point of Contact for Local and International Health Authorities
• Ensuring All Appropriate Calibration Maintenance and Validations are Conducted
• Author and Review Internal Company Reports and Regulatory Documentation
• Lead Audits and Represent the Company
• Advise the Senior Management Team on Relevant Quality Issues and Resource Needs

REQUIRED (Essential)

• Bachelors Degree, or Higher Scientific Qualification
• Demonstrable Industry Experience in a Regulated Environment within the Pharmaceutical Sector
• Proven History in Quality Assurance at a Senior Leadership Level
• Technical Expertise in the Virtual Release Process ie Experience Working with Contract Manufacturing Organisations (CMO) and Extensive Generic Pharmaceutical Industry Knowledge and Experience

REQUIRED (Desirable)

• Qualified Person Status QP – EU Directive 2001/83/EC, Beneficial but Not Essential

REMUNERATION

• £95K + Benefits Package

RESPOND

• Call Terry Blaney on +44 (0)1580 211221 to Learn More about this Career Opportunity or e-Mail terry@arxconsultancy.com with Your Application, Including Your Current CV