Senior Quality Assurance Professional

beBeeQuality; Barcelona; Presencial; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

A leading company in the pharmaceutical industry seeks a QA Contract Manufacturing Senior Manager to oversee quality assurance for Contract Manufacturing Organizations. The role requires substantial experience in external quality management within the pharmaceutical sector, ensuring adherence to regulations while promoting continuous improvement initiatives.

Servicios

Competitive salary and benefits package

Opportunities for career development

Training and mentorship programs

Dynamic and innovative work environment

Talented and diverse team

Formación

• 8-10+ years of external quality management experience.
• Deep knowledge of QA/QC processes in Biologics.
• Proficiency in GXP and international regulatory requirements.

Responsabilidades

• Lead the quality management of Contract Manufacturing Organizations.
• Plan and execute GMP audits as Lead Auditor.
• Drive continuous improvement initiatives related to QA processes.

Conocimientos

Quality Assurance Management

Manufacturing

Quality Control

Change Management

Communication Skills

Negotiation

Regulatory Requirements

Educación

University degree in Life Science

Biotechnology background

Descripción del empleo

Job Title : QA Contract Manufacturing Senior Manager

We are seeking an experienced Quality Assurance professional to lead our Commercial & External Sites Quality Assurance area.

• Ensure excellence in Quality Assurance (QA) management of Contract Manufacturing Organizations (CMOs) and the associated Quality Management System (QMS).
• Leadership of the management and improvement of QMS for external operations on commercial pharma and biopharma products ensuring that needs of commercial production are met and aligns with applicable regulatory standards.
• Provide technical expertise to solve complex quality issues, support manufacturing, QC & QA processes in CMOs and drive continuous improvement initiatives.
• Plan and execute audits acting as Lead Auditor for GMP audits to CMOs, including Biologics manufacturing sites and related supplies / services.
• Involved and manage QA aspects of transfer projects for Pharmaceutical and Biologics and ensure integration into the existing QMS.

Required Skills and Qualifications :

• University degree in Life Science related field.
• Biotechnology background or additional training in biotechnology highly valuable.
• 8-10+ years related experience in external quality management of pharmaceutical / biopharmaceutical products.
• Deep knowledge and direct expertise on Manufacturing / QC / QA & Change Management of commercial Biologics (Drug Substance & Drug Product) is essential.
• Technical working proficiency in quality systems with strong knowledge of GXP and international Regulatory requirements.
• Oral and written communication skills in English are essential.
• Global business environment knowledge and expertise in dealing and negotiation in complex business situations are essential.

Benefits :

This role offers a unique opportunity to work in a dynamic and innovative environment, where you will have the chance to make a real impact on the company's success.

We offer a range of opportunities for career development and growth, including training and mentorship programs, as well as opportunities for advancement within the company.

What We Offer :

• A competitive salary and benefits package.
• The opportunity to work with a talented and diverse team of professionals.
• A dynamic and innovative work environment.
• Opportunities for career development and growth.