QA Manager & QP

Location: Town of Belgium

### General job description

The QA Manager – Qualified Person (QP) assures quality products and processes by establishing and enforcing quality standards and systems. The QA Manager – Qualified Person (QP) assures the continuous improvement and maintenance of the Global Quality Management System (QMS) within and for all departments of the company. He/she ensures that all operations comply with international cGMP regulations and guidelines in general and Belgian laws and regulations in particular, as well as the company’s internal standards.

He/she assures the correct detection, reporting and closure of quality events, changes and other types of quality system related events and the timely release of the manufactured batches. The QP will be responsible for evaluation of execution and reporting of production and QC development activities for the manufacture of API/IMP batches in compliance with etherna procedures, IMPDs and EU GMP.He/she

reports as QA Manager into the Manufacturing Manager and as QP into the CEO and works in close collaboration with QA, QC production and project management departments.## Responsibilities and Duties The
** QA Manager - QP
** duties shall include, but not be limited to:
** GMP Batch Certification
*** Ensuring all manufacturing operations comply with GMP standards and regulations.
* Enforcing the highest quality standards within the QA team.
* Building strong relationships with internal stakeholders to address deviations, change controls, investigations, complaints, and product releases.
* Certifying each API/IMP mRNA batch and managing complaints, recalls, and returns.
* Authorizing retesting, rework, and reprocessing of finished products.
* Approving master batch records and product specification files.
* Reviewing and authorizing regulatory documents when necessary.
* Installing lean quality management system
** Global Quality Management System
*** Establishing, implementing, maintaining, and overseeing a robust Global Quality Management System.
** Product quality and release
*** Ensuring product quality by enforcing quality policies and procedures in line with government requirements and international guidelines.
* Efficiently preparing, reviewing, and releasing batches within agreed timelines.
* Leading the evaluation of production documentation up to QP release
** Personnel
* ** Managing and developing your team, ensuring they are well-equipped to meet quality operational requirements.
* Participating in the selection, orientation, and training of employees and consultants.
* Maintaining staff job results through coaching, supporting and performance appraisals
** Financial objectives
*** Preparing and managing the quality assurance budget as part of the manufacturing budget.
* Analyzing variances and initiating corrective actions as necessary
** Regulatory, audits, inspections and compliance
*** Leading efforts during regulatory inspections and customer audits, showcasing our commitment to compliance.
* Ensuring manufacturing aligns with IMPD or other regulatory documentation from customers or collaborators.
* Collaborating closely with Production, Product Development and QC teams to streamline operations and maintain efficiency.

Other duties as assigned### Job requirements## Education
* Master’s degree in Pharmaceutical Sciences
* License to fulfill Qualified Person services in Belgium## Experience
* Minimum of 5 years of relevant experience in pharma/biotech industry in a similar function.
* Registered Qualified Person in Belgium## Other Qualifications,

Skills and Abilities

* Qualifications:

Proactive, detail-oriented, excellent problem-solving skills, strong management and organizational abilities, exceptional interpersonal skills, knowledge of manufacturing methods, proficiency in process improvement, and detailed documentation practices
* Abilities:
Collaborative, result-focused, well-organized, and adaptable. Strong initiative, fluency in English, and expertise in MS Office tools (Excel, Word, PowerPoint, Outlook)
* A varied job with broad responsibilities within your domain and a central role within etherna's manufacturing services
* A dynamic, enterprising an innovative environment where you can learn a lot
* Employment contract of indefinite duration with a competitive salary package, including benefits
* Working in a fun team where collaboration, growth but above all fun are central### Attention required!
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