QA Manager + QP

The QA Manager – QP assures quality products and processes by establishing and enforcing quality standards and systems. The QA Manager - QP assures the continuous improvement and maintenance of the Global Quality Management System (QMS) within and for all departments of the company and 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 and 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 activities for the manufacture of API/IMP mRNA batches in compliance with eTheRNA procedures, IMPDs and EU GMP.

He/she reports into the Manufacturing Director and works in close collaboration with QA, QC and production 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

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 7 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)

Our offer

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

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