Founded in 2012, EyeD Pharma is a pharmaceutical company dedicated to the development of innovative drug products in ophthalmology. EyeD Pharma is developing innovative products based on a new delivery pathway of well-known drugs with the aim of improving quality of life of patients in various ocular pathologies. 

In 2019, UniD Manufacturing was born, which brings together production activities. In parallel with its R&D and industrialization activities, EyeD Pharma started in 2017 a commercial activity of medical devices (equipment and consumables) for eye surgery.
EyeD Pharma and UniD Manufacturing headquarters are located in the Science Park of Liège.  This collaborative environment will allow a positive synergy between R&D activities, production, logistics and administration.  

To support its development, EyeD Pharma is hiring a R&D QA Manager. He or she is a member of the Quality Assurance Leadership Team reporting directly to the Quality Director. He or she provides leadership and direction for ensuring that development activities are conducted in accordance with relevant standards and regulations to support EyeD’s projects and product registration. He or she must fully support and drive R&D activities, communicate effectively with R&D team members, multiple levels of management, and other support departments.

Your responsibilities

In the Quality department at EyeD Pharma, the RD QA Manager will 

• Manage the RD QA Team through effective employee development, performance management, and recognition.
• Facilitate the daily R&D QA team performance to ensure goals and objectives are met.
• Promote Quality Culture by providing guidance, support, direction and leadership through positive interactions with all personnel.
• Ensure strong alignment and coordination with other business units and departments. 
• Provides oversight and guidance on quality compliance to all departments and project teams.
• Oversee the business unit Quality Management Systems.
• Lead or support the development and/or revision of quality processes, procedures and risk assessment tools, ensuring proactive compliance and adherence to regulations and standards.
• Ensure that documentation supporting development programs and associated registrations are maintained in compliance with company standards and global regulations. 
• Assist in establishing processes to ensure Data Integrity and communicate the principles of data integrity for all R&D activities, including GCP.
• Oversee investigations activities associated with complaints, deviations, CAPAs, etc. and collaborate cross-functionally to ensure risk-based solutions are implemented in a timely manner.
• Make decision regarding quality issues and ensure appropriate communication and/or escalation.
• Utilize knowledge to improve R&D operational efficiency. Work closely with others to identify opportunities for improvement and drive change. Lead teams in continuous improvement project activities.
• Support internal audits.
• Assist with inspection/audit readiness activities for regulatory authority inspections and notified body audits. Participate in and provide direct guidance during external audits and inspections. 
• Communicate audit results to stakeholders. 
• Provides metrics and analytics for Core Team meetings, Management Review, and R&D Leadership Team meetings.
• Provide proactive quality assurance and risk assessment using FMEA, HCCAP, and Quality by Design; and implement risk mitigation measures.
• Plan and lead suppliers’ audits, including clinical investigator site, CDMOs and CROs to determine compliance status and identify compliance risks.
• Participate in the evaluation and selection of suppliers and service providers and ensure appropriate agreements are in place.
• Manage QA budget.
• Practice safe work habits and adhere to EyeD’s safety procedures and guidelines.

Your profile :

• Master of Sciences in Chemistry, Engineering, Pharmacy or the like or equivalent by experience.
• Minimum 7-10 years in quality roles within a pharmaceutical and/or medical device environment.
• Minimum 2 years demonstrated experience in a management and/or leadership role.
• Detailed knowledge of worldwide healthcare product quality compliance regulations (EMA and FDA as a minimum), guidance (including ICH) and standards (including ISO 13485 and ISO 14971). 
• Thorough knowledge of the requirements associated with the development of drug product, medical devices and/or a combination of both.
• Effective leadership skills, including the ability to set goals and provide constructive feedback respectfully to build positive relationships and improve business results. 
• Strong organizational, planning, and follow-up skills and ability to hold others accountable. 
• Ability to multi-task and shift priorities quickly while working under tight deadlines.
• Demonstrated ability to resolve quality and quality system-related issues in a timely and effective manner. 
• Ability to work effectively alone or within a team, in a fast-paced changing environment. 
• Excellent verbal and written communications with ability to effectively communicate at multiple levels in the organization, to foster support and to positively influence all stakeholders.
• Proactive, risk-based approach with strong critical and tactical thinking skills. 
• Mental agility to handle a large quantity and broad scope of information and activities while keeping making sound decisions. 
•  Advanced computer skills in MSOffice applications and experience using enterprise systems (ERP/eDMS/eQMS/LMS, etc). 
• Integrity, team spirit and caring
• Fluent in French and proficient in English at a professional level, both written and spoken
• Prior clinical trial/and/or clinical evaluation experience is an asset.

EyeD Pharma offer 

• A permanent position in an innovative and dynamic and fast growing company;
• Full time ;
• Liège.

Please send your CV and cover letter in English to : job@eyedpharma.com