Four Pharmaceuticals is currently looking to fill the position of Quality Leader to strengthen our Quality Team.

Description of Duties:

*Ensure implementation of Four Pharmaceuticals quality practices and to ensure compliance with cGxP and local regulations.
*Maintain compliant GxP systems, assist in the identification and mitigation of issues and risks, highlight improvement opportunities and facilitate the development of solutions.
*Ensure all regional QA deliverables are achieved in a timely manner and have oversight of the QP activities.
*Establish a Quality Plan and Quality Manual, and key KPI.
*Have oversight on activities related to review, certification and release of marketed products, including Drug Substance, Drug Product, Marketed Products imported from Third Countries and labelled product as appropriate, in compliance with the site licence and duties and responsibilities of the QP.
*Lead and coordinate the Management Review of Quality Systems and procedures for consistency and compliance with all regulations and within the Four Pharmaceuticals standards.
*Monitoring and assessing quality systems by means of audit and self-inspection, and other forms of evaluation against Four Pharmaceuticals and regulatory standards.
*Ensure management of Quality system, eg. complaints, change control, deviations, recalls, counterfeits, product tampering and quality-related problems according to the Four Pharmaceuticals SOPs and local written procedures.
*Define, review and participate in investigations or corrective and preventive actions (CAPA).
*Review and approve deviations, change controls, stabilities, audit follow-up, APRs, QA indicators, validation protocols and reports, variations implementation and GMP agreement updates and enforcement.

Requirements:

*Experience in the pharmaceutical regulated environment primarily in Quality Assurance.
*Be knowledgeable in regulatory and technical requirements of the pharmaceutical industry, have interacted directly with regulatory agencies, and have a strong management background.
*A team player with pertinent people management skills, able to operate and lead in a matrix environment.
*A comprehensive understanding of current regulatory requirements and ability to interpret current and expected new regulations (resulting from BREXIT).
*Experience in preparing for and hosting audits and regulatory inspections.
*QA/compliance experience in quality systems. Areas of expertise should include manufacture and testing of medicinal products (preferably on solid forms), vendor management, regulatory affairs and compliance, validation and technical services.

Four Pharmaceuticals offers employees a comprehensive benefits package that includes competitive salaries, comprehensive medical, dental and vision benefits, paid time off and volunteer hours, education assistance and much more.