Data Integrity Lead/QA-IT

Job description

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing 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 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 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. Data Integrity Lead (QA-IT) About the Role We are looking for an experienced and influential Data Integrity Lead (QA-IT) to drive and strengthen Data Integrity across our pharmaceutical manufacturing site. This is a highly visible leadership role for a senior QA and Data Integrity professional who combines deep compliance expertise with the ability to translate regulatory requirements into practical business solutions. As the site owner for Data Integrity governance, strategy,and compliance, you will define the roadmap, establish and lead the site's Data Integrity Team, and drive a culture where Data Integrity is embedded into daily operations. The ideal candidate brings extensive pharmaceutical industry experience, a strong Quality Assurance background, deep knowledge of Data Integrity regulations and expectations, and the leadership skills required to influence stakeholders across Quality, Manufacturing, Engineering, Automation, and IT. Key Responsibilities Data Integrity Governance & Strategy Own and continuously develop the site's Data Integrity framework, strategy, and roadmap. Define and drive the site's Data Integrity plan, including risk mitigation activities and continuous improvement initiatives. Establish and lead the site's Data Integrity Team. Ensure alignment with company policies, regulatory expectations, and global compliance strategies. Participate in and contribute to global Data Integrity and compliance initiatives. QA Compliance Computerised Systems Provide QA oversight of GxP computerized systems throughout their lifecycle. Review and approve key lifecycle documentation, including: User Requirements Specifications (URS) Risk Assessments Validation Documentation Change Controls Periodic Reviews Ensure compliance with applicable regulations and guidance, including: EU GMP Annex 11 21 CFR Part 11 ALCOA+ principles Risk-based validation approaches (GAMP 5) KPI Management & Reporting Define, monitor, and report Data Integrity KPIs and compliance metrics. Provide regular updates on risks, compliance gaps, trends, and mitigation plans to Site Quality Management and governance forums. Drive visibility and accountability for Data Integrity performance across the organization. Investigations, CAPA & Regulatory Inspections Lead and support investigations related to Data Integrity issues and compliance gaps. Drive robust root cause analysis and effective CAPA implementation. Act as a subject matter expert during regulatory inspections and audits. Support inspection readiness activities and ensure sustainable compliance improvements. Training & Culture Develop and deliver Data Integrity, Annex 11, Part 11, related training programs. Increase awareness and understanding of Data Integrity requirements across the site. Drive a strong Data Integrity culture focused on compliance, quality, and continuous improvement. Required Qualifications To succeed in this role, you bring: 8-10+ years of experience within Quality Assurance, QA-IT and Data Integrity in the pharmaceutical industry. Proven experience leading or driving Data Integrity programs and compliance initiatives within a GxP-regulated environment. Strong QA background within pharmaceutical manufacturing. Experience providing QA oversight of computerized systems and compliance processes. Strong leadership capabilities with the ability to influence and drive change across multiple functions. Excellent communication and stakeholder management skills. Ability to translate complex regulatory and compliance requirements into practical business solutions. Degree in Pharmacy, Life Sciences, Engineering, or a related field, or equivalent experience gained through extensive industry expertise. Fluency in both Swedish and English. Preferred Qualifications Experience working as a QA-IT professional or in a similar QA, Computerized Systems, CSV, or Data Integrity role. Hands-on experience with GxP systems such as MES/LIMS/CDS/eQMS and automation systems Experience implementing large-scale computerized systems or digital transformation programs. Who You Are You are a credible and highly collaborative leader who thrives at the intersection of Quality, Compliance, and Technology. You bring a strong sense of ownership, a proactive mindset, and the ability to create engagement across diverse stakeholder groups. You are equally comfortable discussing regulatory expectations , coaching teams on Data Integrity best practices, and partnering with business and technical functions to implement sustainable compliance solutions. Most importantly, you have the leadership, communication skills, and drive to elevate Data Integrity maturity and build a lasting culture of compliance. If you are a senior QA/Data Integrity professional with deep pharmaceutical expertise and a passion for driving compliance excellence through people, processes, and technology, we would love to hear from you.