ESO Quality Americas Leader

Galderma•Baie-D'Urfé, QC

About The Position

The ESO SRT Quality Lead ensures that all sterile Galderma products produced by Contract Manufacturing Organizations (CMOs) meet the highest quality standards and comply with relevant government regulations. This includes adherence to cGMP, GDP, ISO, ICH, and other applicable regulations and guidance. The role leverages regulatory, industry, and technical expertise to oversee quality at CMOs, support company markets and distributors, and ensure compliance during product development and manufacturing. Products in scope are: semi-solid (majority) and oral products, with drug product status (pharmaceutical/OTC) and cosmetic product status (majority), including products manufactured by Galderma entities and/or subcontracted to external suppliers/partners. He/she Initiates continuous improvements actions and develop business excellence approach across Galderma Manufacturing sites or external partner.

Requirements

Bachelor’s degree in Biology, Biotechnology, Biochemistry, Chemistry, Engineering, Microbiology or another relevant scientific or engineering discipline.
8+ years proven experience in Quality in the pharmaceutical/biopharmaceutical/cosmetic/medical care industry; with at least 5 years supporting worldwide semi-solid production/development (per product scope).
Experience working with CMOs/external suppliers is highly preferred; experience in global lifecycle management and external partner oversight is highly preferred.
In-depth knowledge of cGMP, GDP, ISO, ICH, and other relevant regulatory requirements for sterile products.
Strong Communication and interpersonal skills
Problem-solving skills
Analytical skills
Ability to manage multiple projects and priorities simultaneously
Leadership skills
Ability to work in a global and complex environment

Nice To Haves

Certification in quality management (e.g., ASQ Certified Quality Auditor) is a plus
Six Sigma / Lean Manufacturing certification valuable.
Experience managing remote teams valuable.

Responsibilities

Act as the primary QA contact for external suppliers and provide ongoing quality support.
Lead the approval and renewal of Technical Quality Agreements.
Lead and coordinate Quality Management reviews of external suppliers, defining performance and regulatory compliance-related goals, objectives, and KPIs.
Support investigations, trends, complaints, CAPA, validation support, product release related issues; new product launches/technical transfer to external suppliers.
Resolve critical/major quality issues and discrepancies found through audits, inspections, or complaints and their related investigations, and notify management of significant issues that may impact product quality or regulatory compliance or business continuity.
Ensure alignment with ICH guidelines and other applicable referential (examples listed: ICH Q1, Q3, Q8–Q14, FDA, EU, ISO) and data integrity expectations.
Ensure compliance with GMP/GDP activities related to medicinal products according to EU-GMP and other guidelines, and ensure the team is compliant with all applicable regulations.
Provide technical support to comply with local regulatory requirements and support industrial transfers (production and analytical), particularly for routine products.
Review and approve (if applicable) regulatory documents (CMC sections for pharmaceutical products, PIF for cosmetic products) and associated documentation (INDs, CTAs, IMPDs, BLAs, technical files, etc.).
Support inspection readiness for launches and PAI, and oversee major/critical quality issues arising from audits, inspections, or complaints.