Documentation & Training Manager

Vor 3 Tagen

Schaffhausen, Schweiz Johnson & Johnson Vollzeit

The Quality Systems Documentation and Training Manager is responsible for managing the GMP Documentation and Training process at the Janssen Supply Chain Site Schaffhausen. This individual leads the administration team and supports the development of new ways of training, leveraging a complete array of training solutions to enhance learners’ experience. Strong partnership with the broader training leaders and department heads for effective realization of identified strategy and supports major programs. This individual also serves as POC for enterprise COE teams or global deployments.

**Responsibilities**:

- Site Process Owner for GMP Documentation and Training Process
- Site System Owner for SUMMIT Training Learning Management System
- Site System Owner for TruVault Document Management System
- People Leader for Training and Doc Management personnel. Responsible for Performance and Development of these personnel
- Ensure that all aspects of the Document and Training Programs are compliant to all applicable regulations and standards
- Provide overview or detailed communications to Q&C and cross-functional leadership on status of key processes, initiatives and issues.
- Identifies, supports assessment and documentation of issues that might pose compliance risks, supporting investigation and solutions, actions, and recommendations
- Conduct, execute and document thorough investigations and CAPAs, Audit responses
- Ensure timeliness of results through independent, proactive intervention.
- Bring forward innovative process improvements to drive compliance and/or efficiency.
- Independently handle and prioritize highly complex and diverse workload ensuring deliverables are timely, accurate, and meet their intended objective.
- Review and approve compliance records, procedures and other documents as required

**Qualifications**
- A minimum of a Bachelor’s Degree is required, preferably in Pharma, Biology, Engineering, Chemistry, Biological or Food Sciences field.
- A minimum of six (6) years of GMP experience in either Pharmaceutical, Medical Device, OTC Drug, Cosmetic Production is required.
- Strong people leader skills
- Experience and demonstrated skills in navigating in a matrix environment, handling complexity, collaborating across boundaries, and influencing without authority required.
- Ability to work in a fast-paced environment with multiple, concurrent priorities many needing immediate resolution.
- Strong communication (verbal & written) and interpersonal skills, self-awareness and flexibility required.
- Demonstrated skills in Process Excellence preferred.

**Primary Location**
Switzerland-Schaffhausen-Schaffhausen
- **Organization**
Cilag AG (8562)
**Job Function**
Quality
**Requisition ID**
2206035609W

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