RD QA Manager

EyeD Pharma; Luik; Sur place; EUR 90 000 - 140 000; Plein temps

Avantages offerts par ce poste

Permanent position

Full-time

Résumé du poste

EyeD Pharma is seeking an experienced R&D QA Manager to lead quality activities across development programs and registrations. The role requires ensuring compliance with EMA/FDA standards, ICH guidelines and ISO 13485/14971, while driving improvements in our QA processes.

Key responsibilities include leading QA activities, maintaining the QMS, managing audits and supplier collaborations, and ensuring effective communication with multiple stakeholders in a fast-paced environment.

Qualifications

• Master-level degree or equivalent in a relevant scientific field.
• Minimum 5 years in quality roles within pharmaceutical or medical device environments.
• Minimum 2 years in a leadership role.
• Knowledge of EMA/FDA requirements, ICH, ISO 13485 and ISO 14971.
• Fluent in French and professional English.
• Experience with developing and implementing quality systems and risk management.

Responsabilités

• Lead and direct R&D QA activities to meet goals and compliance.
• Promote Quality Culture and provide guidance across teams.
• Coordinate with other departments to ensure alignment and regulatory readiness.
• Oversee Quality Management System, CAPAs, changes, deviations, and documentation.
• Prepare and manage internal audits and inspections by authorities.

Connaissances

Leadership

Quality compliance

Risk management

Pharma/medical device QA

Documentation management

Audit readiness

Cross-functional communication

Bilingual French/English

Formation

Master of Sciences in Chemistry, Engineering, Pharmacy, Pharmaceutical and Biomedical Sciences

Outils

Veeva Vault

Description du poste

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.

EyeD Pharma headquarter is located in Liège.

To support its development, EyeD Pharma is hiring an R&D QA Manager. He or she provides leadership and direction for ensuring that development activities are conducted in accordance with relevant national and international 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

• Ensure the effective daily performance of the R&D QA activities to meet goals and objectives.
• Promote Quality Culture by providing guidance, support, direction and leadership through positive interactions with all personnel.
• Ensure strong alignment and coordination with other departments.
• Provides oversight and guidance on quality compliance to all departments and project teams.
• Oversee the business unit Quality Management System.
• 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.
• Ensure that complaints, deviations, CAPAs, change controls are written, reviewed and managed correctly and on time.
• 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.
• Develop appropriate internal audits plan and ensure execution.
• Manage 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.
• Represent QA department in any assigned meeting.
• Provide proactive quality assurance and risk assessment using FMEA and Quality by Design; and implement risk mitigation measures.
• Plan and support 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.
• Assume the role of PRRC for the Company.
• Adhere to EyeD’s safety procedures and guidelines.

Your profile

• Master of Sciences in Chemistry, Engineering, Pharmacy, Pharmaceutical and Biomedical Sciences or the like or equivalent by experience.
• Minimum 5 years in quality roles within a pharmaceutical and/or medical device environment.
• Minimum 2 years demonstrated experience in 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 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.
• Adhere to company’s values: team spirit, caring, integrity, efficiency, empowerment.
• Fluent in French and proficient in English at a professional level, both written and spoken.
• Knowledge of Veeva Vault is an asset.
• Prior clinical trial and/or clinical evaluation experience is an asset.

EyeD Pharma offers

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

Liège.