Digital Quality Applications Manager

Insud Pharma; Deutschland; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A global pharmaceutical company is seeking a Digital Quality Applications Manager (LIMS) to lead digital transformation across their Quality organization. The role demands expertise in LabWare LIMS and overseeing global laboratory operations, ensuring data integrity and implementing effective training programs. Ideal candidates should have extensive experience in LIMS management and strong project management skills. This position offers an opportunity to make a significant impact in the pharmaceutical sector.

Qualifikationen

• 7-10 years of experience with LabWare LIMS in a multi-site, global environment.
• Proven success in full lifecycle LIMS implementations or major upgrades.
• Strong understanding of laboratory operations, workflows, and data management.

Aufgaben

• Develop and execute a global LabWare LIMS strategy and roadmap.
• Oversee day-to-day operations of the LIMS system.
• Lead new LIMS implementations, expansions, and module deployments.

Kenntnisse

Fluent in Spanish and English

Strong SQL skills (Oracle, SQL Server)

Excellent project management skills

Ability to work independently and collaboratively in a global team

Attention to detail and commitment to quality

Ausbildung

Bachelor's degree in Computer Science, IT, Chemistry, Biology, or related field

Master's preferred

Tools

LabWare LIMS

Web services

APIs

Middleware

Jobbeschreibung

Position: Digital Quality Applications Manager (LIMS)

Experience:

Minimum 7 years' experience managing and supporting LabWare LIMS in a global, multi-site environment.

Role Overview:

Insud Pharma is hiring a Digital Quality Applications Manager (LIMS) to lead our digital transformation across a global Quality organization. The Global LabWare LIMS Manager will be responsible for strategic planning, implementation, maintenance, and optimization of LabWare LIMS across all laboratory operations worldwide. This role requires deep expertise in LabWare LIMS, laboratory processes, IT systems, and project management, with a proven track record in managing complex LIMS initiatives globally.

Key Responsibilities:

1. Develop and execute a global LabWare LIMS strategy and roadmap aligned with business goals, laboratory needs, and IT architecture.
2. System Management & Support: Oversee day-to-day operations, configuration, and administration of the LIMS system, manage user access, and coordinate system upgrades with IT infrastructure teams.
3. Implementation & Deployment: Lead new LIMS implementations, expansions, and module deployments, including requirements gathering, system design, testing, validation, and go-live activities.
4. Data Management & Integration: Ensure data integrity, oversee data migration, and develop strategies for data archiving and retention, ensuring seamless integration with ERP, ELN, CDS, QMS systems.
5. User Training & Adoption: Develop training programs for users, promote best practices, and maintain detailed documentation of configurations and validations.
6. Project & Vendor Management: Manage LIMS projects from conception to completion, including scope, resources, timelines, and budgets. Implement workflow and data management enhancements.

Qualifications:

• Bachelor's degree in Computer Science, IT, Chemistry, Biology, or related field; Master’s preferred.
• Fluent in Spanish and English; additional languages are a plus.
• 7-10 years of experience with LabWare LIMS in a multi-site, global environment.
• Proven success in full lifecycle LIMS implementations or major upgrades.
• Strong understanding of laboratory operations, workflows, and data management in pharmaceutical, biotech, medical device, or chemical sectors, with knowledge of GxP, ISO 17025, and 21 CFR Part 11 regulations.
• Expertise in LIMS configuration, master data management, instrument interfacing, and reporting.
• Strong SQL skills (Oracle, SQL Server), web services, APIs, middleware.
• Excellent project management skills, capable of managing multiple priorities.
• Ability to work independently and collaboratively in a global team.
• Attention to detail and commitment to quality.

Preferred Qualifications:

• Project Management Professional (PMP) certification.
• Experience with emerging technologies like AI and data analytics in the quality domain.
• Familiarity with agile methodologies and digital transformation frameworks.

Additional Information:

Join Insud Pharma to shape the future of healthcare through innovative digital initiatives. The interview process may include in-person or virtual interviews, possibly with assessments. We are committed to equal opportunity employment and do not discriminate based on ethnicity, religion, age, gender, or other personal circumstances.