Site Quality Head, DS Huningue

Healthcare Businesswomen’s Association; Huningue; Sur place; EUR 70 000 - 100 000; Plein temps

Résumé du poste

A leading healthcare organization in Huningue is seeking a Site Quality Head responsible for managerial leadership in quality matters, ensuring compliance with regulatory requirements and corporate quality policies. The ideal candidate will have 12-15 years of experience in Quality Assurance, a relevant university degree, and fluency in English and French. This role emphasizes talent development, quality culture, and adherence to GMP standards while offering a supportive work-life balance and various employee benefits.

Prestations

Annual bonus

Career development focus

Work-life balance arrangements

Advanced social coverage

27 paid vacation days

Employee recognition programs

Qualifications

• 12-15 years’ experience in Quality Assurance and Quality Control in a pharmaceutical industry.
• Strong technical knowledge in Drug Substance Manufacturing Operations Management.
• Solid stakeholder management with labor unions and Health authorities.

Responsabilités

• Lead the Site Quality organization, ensuring quality oversight of GxP functions.
• Ensure product quality, regulatory compliance, and implementation of corporate quality standards.
• Promote and improve Safety and Quality cultures, ensuring inspection readiness.

Connaissances

Stakeholder management

GMP Quality Control

Drug Substance Manufacturing Operations

Fluent English

Fluent French

Formation

University degree in Pharmacy, Engineering, Chemistry, Biotechnology

Description du poste

Job Description Summary

The Site Quality Head is responsible to provide managerial leadership for the site in all quality related matters and to ensure that key aspects of the operational business comply with cGMP and regulatory requirements as well as the key Novartis corporate quality policies. The Site Quality Head develops and leads the quality teams at the site in line with the Novartis leadership framework and cultural aspirations.

Major accountabilities

• Lead the Site Quality organization, ensuring quality oversight of all GxP functions and acting as the site Technical Responsible Person (Qualified Person).
• Ensure product quality, regulatory compliance, and implementation of corporate quality standards, including maintenance of local HA registrations and preparation of the Site Master File.
• Govern and comply with the Novartis Manufacturing Manual, manage site quality risk assessments, and conduct Quality Management Reviews.
• Approve or reject raw materials, facilities, utilities, intermediates, finished products, stability samples, and PQR/APQR, while overseeing exception and complaint management.
• Ensure effective training execution, data integrity, eCompliance, and adherence to all cGxP, HSE guidelines, and local legal requirements, including business continuity management and collaboration with 3rd parties under appropriate Quality Agreements.
• Drive the talent agenda by recruiting, training, coaching, developing succession plans, promoting talent exchange, and fostering a high-engagement culture aligned with Curious, Inspired, and Un-bossed behaviors.
• Promote and improve Safety and Quality cultures, ensure inspection readiness, support crisis management and Business Continuity Plans, and oversee HSE incident reporting and follow-up.
• Ensure the quality management system conforms to ISO 9001, that processes deliver intended outputs, report performance and improvement opportunities to top management, promote customer focus, and maintain QMS integrity during changes.

Obligatory requirements

• Education : University degree in Pharmacy, Engineering, Chemistry, Biotechnology or equivalent.
• 12-15 years’ experience in the field of Quality Assurance and Quality Control in a pharmaceutical industry environment or equivalent.
• Strong technical knowledge in Drug Substance Manufacturing Operations Management and Execution.
• Solid stakeholder management - especially with labor unions and Health authorities.
• Knowledge of GMP Quality Control (QC) Testing, Manufacturing Process/Product Expertise.
• Fluent English and French (oral and written).

Desirable Requirements

• Additional specialist experience in QC is preferred.

You’ll receive

• Annual bonus
• Focus on career development
• Quality of Work Life approach allowing you to propose improvements for your daily life
• Emphasis on work-life balance with arrangements such as telecommuting, reduced annual working hours, or parental leave
• Advanced social coverage for you and your loved ones
• 27 paid vacation days and at least 14 JDR (days off) days per year
• Various employee recognition programs

Commitment to Diversity and Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.