Digital Quality Systems Manager Job Description
The successful Digital Quality Systems Manager plays a crucial part in the Quality Systems and Standards Team, reporting directly to the Quality Digital and Data Lead.
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This key role is responsible for being the Subject Matter Expert for Quality systems such as SAP QM and Digital QMS. The primary responsibilities include:
* Supporting GMS on Manufacturing execution systems (MES) global quality alignment
* Standardizing global processes and translating them into SAP QM
* Leading workshops, developing & delivering training, protocols, and global procedures
* Partnering with Business owners/areas within Quality to ensure technology solutions are developed, validated, and implemented to meet requirements
The ideal candidate will be a career-driven professional with a strong sense of ownership and a proactive mindset. They will demonstrate exceptional problem-solving abilities and critical thinking skills, enabling them to navigate complex challenges and drive continuous improvement across quality systems and implementation new processes.
Key Responsibilities and Requirements
* Lead Validation Efforts: Oversee the validation processes for global electronic quality systems, ensuring all systems meet quality standards and regulatory requirements.
* Influence senior leadership across a broad group to train, use, and incorporate certain system changes to ensure compliance activities.
* Significant Operations and/or Quality experience in Animal Health/Human Health manufacturing
* Previous Quality Leadership experience
* Experience managing Global Processes and Operating in a Cross-Functional environment
* In-depth knowledge of validation processes, including computer system validation (CSV), and familiarity with relevant tools and software
* Thorough knowledge of FDA and EU regulations, Good Manufacturing Practices (GMPs), and Good Laboratory Practices (GLPs) requirements impacting manufacturing operations
* Advanced Technical knowledge and/or expertise in Computer System Validation including Electronic Records and Electronic Signatures
* Experience with configuration of SAP in Quality Management (QM) and global deployments of ERP within the Pharmaceutical Industry
* Ability to work with multicultural, cross-functional work teams and independently – setting clear direction and aligning team and others around common objectives
* Demonstrated Strong leadership Skills & broad experience that may include multifunctional, multi-site or other functional experience
* Demonstrated success in a Quality Operations/Compliance Role and who can Proactively propose solutions to improve the support of new and existing business processes and demonstrates a strong commitment to product quality, customer service, and continuous improvement
* Ability to analyze data and synthesize to make data driven decisions
* Ability to Develop and implement initiatives
* Broad knowledge of Quality Systems and Risk Management Project Management skills
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