Cosmetic Product Development Jobs in Quebec (NOW HIRING)

Avec un heritage unique en dermatologie ainsi que des decennies d'innovation de pointe, Galderma est le leader emergent de sa categorie dedie entierement a la dermatologie, present dans environ 90 pays. Nous proposons un portefeuille innovant, base sur la science, de marques phares haut de gamme et de services qui couvrent l'ensemble du spectre du marche de la dermatologie en pleine croissance grace a l'esthetique injectable, les soins dermo-cosmetiques et la dermatologie therapeutique. Depuis notre creation en 1981, nous avons consacre notre attention et notre passion a l'organe le plus grand du corps humain - la peau - en repondant aux besoins individuels des consommateurs et des patients avec des resultats superieurs, en partenariat avec les professionnels de la sante. Parce que nous savons que notre peau faconne l'histoire de notre vie, nous faisons progresser la dermatologie pour chaque histoire de peau.
Nous recherchons des personnes qui se concentrent sur l'obtention de resultats, ont envie d'apprendre et apportent une energie positive. Ils doivent allier initiative, esprit d'equipe et de collaboration. Avant tout, ils doivent etre passionnes par l'accomplissement de quelque chose de significatif pour les consommateurs, les patients et les professionnels de la sante que nous servons chaque jour. Nous visons a responsabiliser chaque employe et a favoriser leur developpement personnel tout en veillant a ce que les besoins de l'entreprise soient satisfaits maintenant et a l'avenir. Dans notre entreprise, nous encourageons la diversite et respectons la dignite, la vie privee et les droits personnels de chaque employe.
Chez Galderma, nous donnons activement a nos equipes des raisons de croire en notre ambition affirmee de devenir la premiere entreprise de dermatologie au monde. Avec nous, vous avez l'opportunite exceptionnelle d'acquerir de nouvelles experiences professionnelles enrichissantes et de creer un impact direct et sans precedent.

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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.

Main accountabilities

External supplier (ESO/CMO) quality management

• 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

Regulatory and compliance oversight

• 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.

Regulatory documentation and inspection readiness

• 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.

Critical skills/competencies

• Technical knowledge: 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

Required education/experience

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