Qualified Person & Quality Unit Director

HUMAN VALUE S.R.L.; Unione di Comuni della Romagna Forlivese; In loco; EUR 60.000 - 100.000; Tempo pieno

Descrizione del lavoro

An established industry player in the pharmaceutical sector is seeking a Quality Director & Qualified Person to lead a pivotal transition. This role involves ensuring regulatory compliance, overseeing quality controls, and managing a dedicated team. The ideal candidate will possess a degree in a relevant field, strong leadership skills, and a deep understanding of GMP standards. This is a unique opportunity to contribute to a prestigious company during a significant growth phase, making a meaningful impact on quality assurance and compliance processes.

Competenze

• Degree in pharmaceutical chemistry, pharmacy, or related field.
• Licensed to practice and registered with the professional board.

Mansioni

• Ensure compliance with GMP and legal standards for product release.
• Oversee quality control and manage stability studies.

Conoscenze

Regulatory Compliance

Quality Control

Leadership

Problem Solving

Negotiation Skills

Formazione

Degree in Pharmaceutical Chemistry

Degree in Pharmacy

Degree in Biological Sciences

Strumenti

Office Software

Specialized Departmental Software

Descrizione del lavoro

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Qualified Person & Quality Unit Director, 03 - Italia/Toscana

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Other

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EU work permit required:

Yes

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Job Reference:

218088184

Job Views:

2

Posted:

27.04.2025

Expiry Date:

11.06.2025

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Job Description:

The Context

A renowned and historic production company in the pharmaceutical sector, known for its diversified product range and commitment to the highest international quality standards, is currently seeking a Quality Director & QP. This pivotal role will help navigate the company through a significant transition period.

The Role
We are looking for an exceptional candidate to take on the dual responsibilities of Qualified Person and Quality Director (QC and QA), overseeing a substantial team of direct and indirect reports. Key responsibilities include:

• Regulatory Compliance: Ensuring full adherence to legal requirements for the Qualified Person in interactions with local and European Authorities.
• Batch Release: Guaranteeing that each batch is analyzed and released for market distribution in compliance with GMP and relevant legal standards in Italy and destination countries. Ensuring the production facility maintains its manufacturing authorization and operates within regulatory guidelines.
• Development Support: Deciding on the introduction of new products and technologies, ensuring regulatory compliance, securing necessary authorizations, and adhering to legal provisions.
• Quality Control: Overseeing quality controls, chemical, and physicochemical analyses of finished products, raw materials, and packaging, as well as microbiological analyses in compliance with GMP standards. Supporting all validation activities.
• Stability Studies: Managing stability studies and documentation according to current regulations and ICH guidelines.
• Quality System Management: Leading the Quality System area with a team dedicated to the documentation and procedural aspects of Quality.

The Context

A renowned and historic production company in the pharmaceutical sector, known for its diversified product range and commitment to the highest international quality standards, is currently seeking a Quality Director & QP. This pivotal role will help navigate the company through a significant transition period.

The Role
We are looking for an exceptional candidate to take on the dual responsibilities of Qualified Person and Quality Director (QC and QA), overseeing a substantial team of direct and indirect reports. Key responsibilities include:

• Regulatory Compliance: Ensuring full adherence to legal requirements for the Qualified Person in interactions with local and European Authorities.
• Batch Release: Guaranteeing that each batch is analyzed and released for market distribution in compliance with GMP and relevant legal standards in Italy and destination countries. Ensuring the production facility maintains its manufacturing authorization and operates within regulatory guidelines.
• Development Support: Deciding on the introduction of new products and technologies, ensuring regulatory compliance, securing necessary authorizations, and adhering to legal provisions.
• Quality Control: Overseeing quality controls, chemical, and physicochemical analyses of finished products, raw materials, and packaging, as well as microbiological analyses in compliance with GMP standards. Supporting all validation activities.
• Stability Studies: Managing stability studies and documentation according to current regulations and ICH guidelines.
• Quality System Management: Leading the Quality System area with a team dedicated to the documentation and procedural aspects of Quality.

The Requirements

• Educational Background: Degree in pharmaceutical chemistry and technology, pharmacy, chemistry, industrial chemistry, biological sciences, medicine and surgery, or veterinary medicine.
• Professional Credentials: Licensed to practice and registered with the professional board.
• Language Skills: Advanced English proficiency (minimum level B2).
• Regulatory Knowledge: Deep understanding of GMP and industry regulations.
• Process Expertise: Extensive knowledge of internal and general production processes.
• Quality Systems: Thorough familiarity with the company's quality system and current procedures.
• Technical Skills: Proficiency in office and specialized departmental software.
• Safety Standards: Knowledge of laboratory safety regulations.
• Leadership and Collaboration: Strong decision-making, leadership, and team development skills.
• Problem Solving: Effective problem-solving abilities.
• Negotiation Skills: Proven negotiation capabilities.
• Strategic Vision: Ability to plan and maintain a comprehensive vision.
• Confidentiality: Commitment to maintaining confidentiality.

This is a unique opportunity to play a critical role in a prestigious company during a key phase of its growth and transformation. If you possess the expertise and drive to excel in this role, we would love to hear from you.