Quality Assurance Manager

at  CNX Therapeutics Ltd

BACKGROUND, SKILLS AND EXPERIENCE

• Background in pharmaceutical GMP and Quality Assurance with focus on remote management of third party contract manufacturing vendors and service providers; knowledge of GMP requirements; management and maintenance of a Quality Management System and all associated activities (Deviations, Change Controls, Customer Complaints etc.).
• Experience of working in GMP QA at a manufacturing site and/or managing third party vendors essential; internal and external audit experience preferred; experience of interactions with global Health Authorities; history of continual improvement initiatives; due diligence for acquisitions and subsequent integrations.
• Skills – Root cause analysis; problem solving; risk assessment; critical thinking; process development and improvement; effective interactions with key partner groups (PV, Regulatory, Technical, Supply Chain); Communicating with and managing third party relationships.
• Role will involve approx. 10% travel

THE ROLE:

Leading the QA department and managing internal and external customers to achieve a common goal and ensure GxP activities e.g., GDP, GMP, GVP conducted by CNX are implemented and controlled.
A varied role requiring leadership and management of selected tasks and priorities to ensure that CNX systems and procedures comply with relevant standards, guidelines and regulations, primarily European Directive 2003/94/EC for Good Manufacturing Practice, and European Union Guidance on Good Manufacturing Practice Part 1: Basic Requirements for Medicinal Products, Guidelines, but also Good Distribution Practice of Medicinal Products for Humans 2013/C 343/01.

CORE TASKS & RESPONBILITIES:

Live the CNX Values. Maintain high standards of ethics, and support the company in its efforts to have a pioneering approach to environmental, social and governance (ESG).