Quality Audit Lead

ProPharma Group

United Kingdom

The Quality Audit Lead is responsible for serving as the central regional point of control for Audit Management, and related Quality Management System activities. Develops, manages, and executes quality audit management processes to ensure quality standards are maintained and compliant with regulatory requirements. Drives positive change and process improvement in the assigned region. This role functions as an independent and objective entity and operates in a multifaceted function by working and supporting various operational teams. The Quality Lead performs quality activities as outlined in ProPharma’s Quality Policy and procedures.

Main Responsibilities:

Acts as host for client audits and regulatory inspections at ProPharma, and acts as SME for quality topics.
Supports clients with audits and inspections relating to the service provision. Maintains awareness of and ensure adherence to applicable SOP’s/ controlled documents, regulations, and all types of client agreements.
Serves as control point for Audit or Inspection related SOPs/ controlled documents and Quality Management System documents.
Contributes to the creation of controlled documents such as SOPs and Work Instructions.
Supports the delivery of the internal quality program including quality assurance and quality control.
Collaborates with Operational and Client Services Managers to prepare for client audits and regulatory inspections.
Develops responses to CAPAs arising from client audits and regulatory inspections at ProPharma, with support from Operations Managers, Client Services and Global Quality, and tracks to completion and closure.
Participates in relevant client operational meetings as directed by Management.
Supports the Quality Manager in the Regional Quality Committee and acts as a regional representative in the Global Quality Committee.
Proactively identifies improvement opportunities to support the continuing development of ProPharma as a leading provider of outsourced global Medical Information and Pharmacovigilance solutions.
Identifies any issues which could potentially impact services and escalates any areas of concern within the business to Management, with potential corrective actions.

Necessary Skills and Abilities:

Significant Quality experience in pharmaceutical or medical device industries or other regulated industries (i.e., healthcare)
Good understanding of quality assurance regulations and guidelines preferably related to GxP.
University/Bachelor’s degree and/or appropriate relevant work experience
Quality Assurance experience in internal and external audits, and maintaining regulated documents and training files, preferable related to GxP.
Previous experience of data mining, analysis, and presentation.
Previous audit experience required.
Excellent attention to detail and focus on quality.
Strong verbal and written communication skills.
Excellent workload management skills.
Ability to prioritize workload and meet deadlines.
Possesses a service-oriented approach.
Flexible and proactive toward changing needs.
Proficiency with use of MS Word, Excel, and PowerPoint.