eQMS BPO Quality System Manager
eQMS BPO Quality System Manager
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Job Description
Galderma is the emerging pureplay dermatology category leader present in approximately 90 countries. We deliver an innovative sciencebased portfolio of premium flagship brands and services that span the full spectrum of the fastgrowing dermatology market through Injectable Aesthetics Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981 we have dedicated our focus and passion to the human bodys 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 are 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 Galdermas Global Capability Center offers numerous possibilities for professional development such as exposure to global and crossfunctional projects and access to global career opportunities.
At Galderma were unique and we embrace difference.
Whether its the unique breadth of our integrated offering that covers Aesthetics Consumer and Prescription products; or our commitment to recognising and rewarding people for the contribution they make working here isnt like anywhere else.
At Galderma we actively give our teams reasons to believe in our 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.
We established a new Global Capability Center in Barcelona supporting our global commercial and functional teams. Located in the upscale Eixample District in the heart of Barcelona Galdermas Global Capability Center offers the possibility for professional development through exposure to global and crossfunctional projects and access to global career opportunities.
Job Title: eQMSBPO Quality System Manager
Location: Barcelona Spain. Hybrid
Job Description
You will be responsible for maintaining and developing Galdermas key quality management processes such as Deviation Change Control CAPAs and Complaints. You will drive the electronic Quality Management System (eQMS) associated with these processes ensuring that this tools and documentation remain compliant with relevant government regulations including cGMP GDP ISO and Medical Devices regulations. Your role will involve ensuring that appropriate personnel are properly and efficiently trained according to the requirements. You will also be tasked with regulatory surveillance on those processes interpreting evolving regulations including best practices and updating processes accordingly to maintain compliance and support continuous improvement..
Key Responsibilities
- Manage the Global Quality Processes for Galderma in collaboration with his/her Manager on the following responsibilities :
- The Global Business Process Owner (BPO) for the Quality processes such as Deviation Change Control CAPAs Complaints and for the electronic Quality Management System (eQMS)
- Provides guidance ongoing support and leadership to internal stakeholders and external partners for the Quality Processes and implementation/improvements of the eQMS
- Designs and maintains the Quality Processes and the eQMS to remain compliant with global regulations and company requirements for drug medical device and cosmetic products.
- Partners with the Quality and IT organizations to ensure strategic Quality System initiatives are implemented including integration harmonization continuous improvement and Quality Systems technology advancements.
- Collaborate with GxP business partners in eQMS incident evaluations investigations risk assessments validation deliverables and change management.
- Develop and maintain a network of local first line owners for the eQMS ensuring local user support
- Update the appropriate documentation (SOPs INS) and training plan for the users. Ensure an efficient training is deployed and delivered as appropriate.
Skills & Qualifications
- At least 10 years of relevant experience in the Medical Device pharmaceutical or biopharmaceutical industry.
- A prior 5 years experience as Quality System Manager (or equivalent) for in an international company is required. Practical knowledge on training programs is required.
- A sound knowledge of the applicable regulations and regulation surveillance tools for (including biologics) and/or medical devices. Further knowledge of the cosmetic industry regulations is a plus.
- A demonstrated knowledge and of Quality System Management (including the regular use of electronic systems such as eQMS eDMS etc.
- A demonstrated knowledge of interpretation of regulations into a companys documentation
- A knowledge of electronic learning management systems (LMS)
- Technically skilled to work with electronic systems developing reports or tools (such as Power BI)
- Medical Device applicable regulations GMP (FDA EU ICH PICs regulations cGMPs related to all major territories)
- The applicant shall hold as a minimum a Bachelors degree preferably in Life Science.
- Written and oral Business English. Any other language is a plus.
What we offer in return
You will be working for an organization that embraces diversity and inclusion believing that better outcomes are achieved by reflecting the perspectives of our diverse customer base. The role will focus on improving the global quality processes and the global eQMS while developing a long term plan to evolve ways of working including technologies. The role will be based in Barcelona within a very dynamic team which includes quality team mates but also a lot of other functions.
Next Steps
- If your application is successful and your profile is a match we will invite you for a first virtual conversation with the recruiter.
- The next step is a virtual conversation with the hiring manager
- The final step is a panel conversation with the extended team
Our people make a difference
At Galderma youll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism collaboration and a friendly supportive ethos is the perfect environment for people to thrive and excel in what they do.
Required Experience:
Manager
Employment Type
Full-Time
