Functional Business Relationship Manager Quality
vor 2 Wochen
With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology.
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 to promote their personal growth all the 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 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 unparalleled, direct impact.
**Job Description**:
Reporting to the Senior IT Director R&D, Functional Business Relationship Manager for Quality and Regulatory Affairs business at Galderma leads the following processes:
- for Quality Assurance - Design and maintenance of the EQMS that aligns with global regulations and company requirements for drug, medical device, and cosmetic products;
- for Quality Control
- Design and maintenance of LIMS that aligns with local business requirements covering drug, medical device, and cosmetic products;
- Quality document management system that consolidates applicable regulations and internal requirements in a harmonized approach through documents and computerized system;
- Audits;
- Submission to Health Authorities (Regulatory Affairs).
**Responsibilities**:
As BRM for Quality and Regulatory Affairs IT:
- Represent Global IT in front of business stakeholders: “One IT” mindset
- Build close relationships with global Business stakeholders, including Regulatory Affairs and Global Quality leaders
- Implement regular BRM meetings with key Business stakeholders
- Build Quality and RA IT roadmap, defining milestones, resources, and budget
- Propose opportunities for enhancements, efficiency improvements and simplification
- Build business cases for new ideas of projects in collaboration with Business and IT stakeholders: assess benefits/stakes/workload/resources/budget before submission to CAB (Change Advisory Board)/BRM committee
- Lead Quality and Regulatory Affairs IT roadmap execution
- Manage partners and external teams contribution to programs & projects
- Collaborate with team members and other IT teams to continually improve Service Levels (Incidents/Requests/Changes), Security Compliance and User Satisfaction of the systems that support Quality & Regulatory Affairs processes
- Is accountable for the services towards the business
As the IT guardian of the Quality & Regulatory Affairs core models:
- In collaboration with Business stakeholders, ensure IT documentation that supports the Quality and Regulatory Affairs core models is up to date
- Ensure ADMS teams are trained and coached so that Quality and Regulatory Affairs core model is fully understood and taken into account during incident/service/change processes
- Promote and implement Quality and Regulatory Affairs core model best practices, business models and processes
As member of the IT Extended Management Team:
- Contribute to set direction of the Global IT organization
**Requirements**:
- Business Degree in Life Sciences, Management and/or IT
- 15+ years of professional experience in a similar position, across multi functions and business processes including Regulatory Affairs or Quality function (operational) and consulting
- Alternatively, more than 15 years’ experience in a consulting role, particularly working with companies involved in transformation project
- Experience in a Pharmacy/Medical devices company is preferred
- Strong presence and outstanding written and verbal communication skills
- Ability to communicate with and influence senior leaders, as well as ability to establish new relationships quickly
- Business mindset/stakeholder management skills; strong executive presence
- Strong time and work management capabilities, with ability to prioritize initiatives and execute to completion
- Experience in a fast-paced environment: commitment to execution in a rapidly changing and evolving environment
- Experience in Agile project management methodology
- Collaborative, yet able to operate independently; self-motivated/driven yet able to lead and influence in a matrixed environment
- Mission-oriented and passionate about the delivery of quality customer care
- Enjoys working within a fast-paced, high-growth and rapidly changing environment
- International, multicultural work experience
- Fluency in English
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