Site Quality Head

Siegfried; Barberà del Vallès; Sur place; EUR 110 000 - 160 000; Plein temps

Avantages offerts par ce poste

Annual Bonus

Company car

Free parking

Canteen on-site or restaurant ticket

Medical, life, and accident insurance

Club Siegfried

Résumé du poste

Siegfried is seeking a Site Quality Head to oversee QA and QC, ensuring GMP and ISO 13485 compliance across the site. You will lead quality strategies, budgets, and cross-functional collaborations to uphold patient safety and regulatory standards.

Ideal candidates have a Pharmacy degree, advanced regulatory knowledge, and experience in a CDMO environment with large teams. The role offers long-term growth and a pivotal position within Siegfried’s global quality network.

Qualifications

• Pharmacy degree required.
• MBA valued as a plus.
• Knowledge of FDA, MHRA, EMA, WHO, GxP and ICH regulations.

Responsabilités

• Lead and manage QA and QC functions.
• Ensure compliance with GMP, ISO 13485, ICH guidelines and Siegfried Quality requirements across site operations.
• Define, execute and monitor departmental budget and resource planning.
• Act as Medical Devices Management Representative per ISO 13485.
• Drive continuous improvement and quality culture across the site.

Connaissances

Quality leadership

GMP compliance

Regulatory knowledge

Budget management

Cross-functional collaboration

Formation

Pharmacy degree

MBA valued

Regulatory knowledge (FDA/MHRA/EMA)

Description du poste

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.

The Site Quality Head is responsible of managing the QA and QC departments, ensuring the compliance with the overall strategy of Quality. He/She is responsible of managing the department in terms of operations, projects, resources and policies.

Your Role:

Main responsibilities of the Site Quality Head are:

• Ensure compliance with GMP requirements, ISO 13485 standards, ICH guidelines, the Siegfried Quality Manual, and all applicable SOPs across site operations.
• Lead and manage the Quality Assurance (QA) and Quality Control (QC) functions.
• Ensure that all site products, projects, processes, strategies, and decisions comply with applicable GMP, ISO 13485, and Siegfried Quality requirements.
• Serve as the primary point of contact for Global Quality matters and ensure the effective implementation and ongoing adherence to Siegfried Quality policies and standards.
• Define, execute, and monitor the annual departmental budget. Ensure the effective allocation and utilization of human and financial resources to achieve departmental objectives efficiently.
• Foster a quality-first culture and continuous improvement mindset across the site.
• Provide overall leadership and accountability for product quality, patient safety, regulatory compliance, and quality performance.
• Lead the site's Quality Strategy and Quality Plan, ensuring continuous improvement and alignment with corporate objectives
• Act as the Medical Devices Management Representative, assuming the responsibilities and authority defined in ISO 13485.
• Ensure compliance with all applicable Safety, Health, and Environment (SHE) requirements and standards.
• Ensure sustained MRP II Class A performance through robust planning, governance, and cross-functional collaboration.

Your Profile:

Education:

• Pharmacy degree
• MBA will be valued
• Knowledge in FDA, MHRA, EMA, WHO, GxP and ICH regulations

Local language and English advanced.

Experience in pharmaceutical CDMO environment is strongly preferred.

Exposure to customer audits, regulatory inspections, technology transfers and multi-client management is required.

Experience in managing large teams.

Valued competencies:

• Strong communication skills
• Leadership and proactivity
• Customer and Quality Focus
• Results oriented

Your Benefits:

• Annual Bonus
• Company car
• Free parking
• Subsidized canteen on-site or restaurant ticket: to use when eating out or working from home
• Medical, life, and accident insurance
• Access to "Club Siegfried": an exclusive platform with discounts and offers on over 400 services.

If you’re excited by the idea of joining our group,we’d love to hear from you.

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents. With a team of more than 4,200 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.