Ensure and support overall GxP conformity and compliance with the Novartis Quality Manual, the law and other policies / procedures in processes like e.g. document management, change control system, training, escalation management, risk management, qualification / validation and CSV
Job Description
Global QMS RDQ Specialist
About the Role:
As an experienced specialist drive efficiency and productivity gains through contributing to the implementation of new processes to administer a validated Global Learning Man-agement System (LMS) covering multiple GxP areas in full alignment with Development and QA business goals and strategic objectives.
Management of GDD GxP Training content in LMS achieving full regulatory training compliance.
Key Responsibilities:
- Manage user accounts for global Development Global Learning Management System (LMS)
- Release training assignments in the LMS based on applicability s in STAR
- Update STAR and LMS as per LF Request (Applicability s Change Request process)
- Training systems document maintenance
- New/Remove/Update Roles in STAR and LMS
- Provide technical or administrative support for users
- Maintain access to LFRC and LFAR upon request
- Adhere to the global LMS Admin guidelines
- Ensure harmonization of LMS usage in global Development
- Perform validation activities - Validation Report, QC of releases, etc
- Brings up in a timely manner any Level 2 issues related to the LMS
- Be a role model for the Novartis values and behaviors and support the journey towards an inspired, curious, unbossed and self-aware organization
- Seek and implement opportunities for improving efficiency and effectiveness in our training system.
Essential Requirements:
- Significant relevant work experience ( 5 years) in the pharmaceutical industry or public health sector, in the area of Quality, Human Resources or Training.
- Demonstrated knowledge in implementing/managing robust Document management systems and Learning Management Systems, setting global quality controls in a regulated area
- Sound understanding of regulated activities, health authority expectations, and GxP, paired with good business understanding.
- Role model for the Novartis values and behaviours and exemplary interpersonal skills
- Excellent leadership, interpersonal, communication, negotiation and problem solving skills
- Ability to innovative when faced with opportunities or challenges.
- Ability to influence and drive/facilitate change across the organization.
Desirable Requirements:
- Bachelor/Technical degree in Life Sciences or related fields. Advanced degree and/or MBA an advantage
Skills Desired
Compliance Requirements, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Quality Management Systems (QMS), Quality Standards, Risk Management, Self-Awareness, Technological Expertise, Waterfall Project Management
