Business Process Expert for LIMS, focusing on implementation and support within Quality Control. Join a collaborative international team at Grünenthal to enhance our pharmaceutical manufacturing standards.
About the role
- Engineer IT Compliance responsible for compliance activities in regulated IT systems. Building partnerships with IT functions and ensuring regulatory alignment in pharmaceutical industry.
Responsibilities
- Execute compliance activities for systems, such as plans, reports, tests, changes, periodic reviews, and deviations
- Provide necessary support to meet regulatory and information security requirements for regulated systems projects
- Serve as the primary contact for CSV-related matters for GxP-computerized systems and act as a liaison between technology-based solutions and the IT Compliance on IT GRC unit
- Review and approve project-related documents for GxP relevant systems, including determining GxP-applicability for all GxP- and non-GxP relevant systems
- Establish a trusted partnership with the assigned IT technology-based function, understanding business drivers, and provide required day-to-day operational support
- Review and approve GxP-impacted deviations, ensuring appropriate CAPA implementation
- Contribute to the preparation of compliance strategies and execute plans for systems associated with respective functions
- Review and approve periodic review reports for GxP computerized systems and manage any gaps within the CAPA management system
- Provide audit support as assigned and offer necessary compliance support for any resulting CAPAs
Requirements
- University degree in Information Technology, Life Sciences, Pharmacy, Engineering or equivalent level
- A minimum of 3 years of overall IT experience
- A minimum of 5 years of relevant experience in the pharmaceutical industry and in particular within regulated functions such as IT quality and compliance
- Solid understanding of global regulations and health authorities’ expectations governing computerized systems (CSV, Part 11, etc.)
- Solid experience in the development, implementation and lifecycle management of computerized systems in regulated environments
- Experience in quality management of premises and cloud-based regulated environments
- Highly experienced in the operational management of GxP-solutions, including its related technologies to support the operation
- Good understanding in system application management, its quality support approach and industry best practices (ITIL, ITSM, etc.)
- Experience in the development, implementation and lifecycle management of key computerized systems in pharmaceutical development, manufacturing, quality, commercial and infrastructure space (e.g. ERP/SAP, MES, LIMS, CRM, IAM, etc.)
- Strong analytical and problem-solving mindset and the ability to think critically and strategically
- Proficient conflict management skills to mediate and resolve disagreements between stakeholders
- Excellent written and verbal communication skills for clear communication, content delivery, and stakeholder interaction.
Benefits
- flexible hours
- vacation account
- Digital Learning
- Performance & talent development
- leadership development
- Apprenticeships
- LinkedIn Learning
- Company bike
- Job ticket
- Deutschlandticket
- Employer-funded pension
- Childcare
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
Quality & Regulatory Specialist at SofMedica ensuring compliance with quality standards and managing quality management systems. Overseeing supplier qualifications and participating in audits.
Team Leader - Compliance Training responsible for designing and developing compliance training programs in financial services. Leading a team and managing training implementation activities in India.
Regulatory Toxicologist supporting clients on product registrations, toxicological evaluations, and risk assessments in the chemical sector. Join a leading sustainability consultancy with a focus on agrochemicals.
Consultant GRC confirmed assisting clients in strategic aspects of cybersecurity. Working on risk analysis and compliance with standards in a hybrid role in Courbevoie.
Solution Owner overseeing Trackwise systems for regulatory and quality solutions at Convatec. Balancing technical expertise with strategic vision to optimize processes and maintain system integrity.
Digital Communications Surveillance Analyst at S&P Global Ratings monitoring electronic communications for regulatory compliance. Collaborating with global teams and identifying potential compliance issues.
Senior Director overseeing Quality & Regulatory Strategy for innovative medical device company. Partnering with executives to drive compliance and operational excellence in a regulated environment.
Risk & Compliance Manager overseeing compliance frameworks at Plenti, a growing fintech lender. Bridging regulatory compliance and operational risk to support sustainable growth.
Compliance Testing Manager responsible for planning and executing compliance testing and validations. Leading specialist teams while ensuring regulatory compliance in the U.S. banking sector.