Quality Assurance Project Manager
hace 2 semanas
With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries.
We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology.
Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals.
Because we understand that the skin we're in shapes our lives, we are advancing dermatology for every skin story.We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration.
Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day.
We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future.
Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world.
With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
Further supporting our growth and innovation momentum, we are establishing a new Global Capability Center in Barcelona to deploy new capabilities to effectively support its global commercial and functional teams.
Located in the upscale Eixample District in the heart of Barcelona, Galderma's Global Capability Center offers numerous possibilities for professional development such as exposure to global and cross-functional projects and access to global career opportunities.
Job Title:
Quality Assurance Project Manager
Location:
Hybrid, Barcelona
Job Description:
Ensure Galderma products meet the Company quality standards and comply with the relevant government regulations according to the product applicable classification: cGMP, GDP, ISO, ICH or any relevant regulations and guidance.
- Holding overall responsibility and ownership for the project results which includes strategy development, scoping, planning, execution, and budget/resource management, from initiation through implementation.
- Manage Analytical transfer or other specific projects to manufacturing sites
- Technical Transfer Lead Responsible for technology transfer activities at site level (within, inbound and outbound), including any scaleup or other process adaptations.
- Lead technical transfer project team at site and liaises efficiently with involved functions such external partners, Supply Chain, Production Unit, Quality Control, HSE, other sites.
- Track and report progress across projects by reviewing schedules and due dates, identifying risks and assisting teams with contingency plans.
- Maintain accurate and up to date record of Project activities, including project status, risk & issues
- Prepare reporting to Managing Committees (Project Committees, Technical Review, Project Review Board, Interfaces, Highlights, etc.).
- Assess manufacturing capability & capacity as part of new supplier selection or existing supplier gap analysis activity. Ensure technical excellence in operational startup for new manufacturing equipment and areas
- Assess and process supplier and company changes, ensuring product impact is appropriately considered.
- Supports CMO on technical activities during development and commercial manufacturing
- Bachelor's degree in Pharmacy, Biology, Biotechnology, Biochemistry, Chemistry, Engineering, Microbiology or another relevant scientific or engineering discipline; advanced degree is preferred.
- Six Sigma / Lean Manufacturing certification is a serious plus.
- At least 5 years of experience in a quality assurance role within the pharmaceutical or biopharmaceutical industry.
- Excellence operational knowledge of pharmaceutical manufacturing processes, including sterile production.
- Familiarity with regulatory requirements, including cGMP, FDA regulations, and international guidelines.
- Ability to work independently and collaboratively in a dynamic, fastpaced environment.
- Previous experience in leading or participating in regulatory inspections and audits.
- Excellent communication, problemsolving, and decisionmaking skills.
- Fluent in English
- You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.
- You will receive a competitive compensation packa
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