At a Glance
- Tasks: Lead quality management for external suppliers and ensure compliance with industry regulations.
- Company: Galderma, a leader in dermatology with a focus on innovation and quality.
- Benefits: Empowering work environment, opportunities for personal development, and commitment to diversity.
- Other info: Join a dynamic team dedicated to advancing dermatology and improving lives globally.
- Why this job: Make a meaningful impact in the dermatology field while working with a passionate team.
- Qualifications: Bachelor’s degree in a relevant field and 8+ years of quality experience in the industry.
The predicted salary is between 98550 - 120450 $ per year.
Avec un héritage unique en dermatologie ainsi que des décennies d'innovation de pointe, Galderma est le leader émergent de sa catégorie dédié entièrement à la dermatologie, présent dans environ 90 pays. Nous proposons un portefeuille innovant, basé sur la science, de marques phares haut de gamme et de services qui couvrent l'ensemble du spectre du marché de la dermatologie en pleine croissance grâce à l'esthétique injectable, les soins dermo-cosmétiques et la dermatologie thérapeutique.
Nous recherchons des personnes qui se concentrent sur l'obtention de résultats, ont envie d'apprendre et apportent une énergie positive. Ils doivent allier initiative, esprit d'équipe et de collaboration. Avant tout, ils doivent être passionnés par l'accomplissement de quelque chose de significatif pour les consommateurs, les patients et les professionnels de la santé que nous servons chaque jour.
Main accountabilities:
- Initiates continuous improvements actions and develop business excellence approach across Galderma Manufacturing sites or external partner.
- 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.
Regulatory and compliance oversight:
- Ensure alignment with ICH guidelines and other applicable referential.
- Provide technical support to comply with local regulatory requirements and support industrial transfers.
- Review and approve regulatory documents and associated documentation.
- Support inspection readiness for launches and PAI, and oversee major/critical quality issues arising from audits, inspections, or complaints.
Critical skills/competencies:
- 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.
- Experience working with CMOs/external suppliers is highly preferred.
- Certification in quality management is a plus; Six Sigma / Lean Manufacturing certification valuable.
- Experience managing remote teams valuable.
ESO Quality Americas Leader in Winnipeg employer: Galderma
Galderma is an exceptional employer that fosters a collaborative and innovative work culture, making it an ideal place for a Responsable Technique – Packaging. With a strong focus on employee growth and development, you will have access to international projects and the opportunity to work alongside talented professionals in a dynamic environment. Located in a vibrant setting, Galderma offers competitive benefits and a commitment to quality and safety, ensuring that your contributions are valued and impactful.
