Global Labeling Compliance Manager
il y a 2 semaines
Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for a Global Labeling Compliance Manager to be located in Wayne, PA; Spring House, PA; Raritan, NJ; Titusville, NJ; Toronto, Ontario (CA); UK (High Wycombe); Netherlands (Leiden); Belgium (Beerse); Allschwil, Bern, Zug (Switzerland). Remote work options may be considered, on a case-by-case basis and if approved by the Company.
Our company thrives on diverse company culture, celebrating the uniqueness of our employees, and is committed to inclusion. Janssen is proud to be an equal opportunity employer. Our culture is interconnected by the shared values of Our Credo. It is a culture that celebrates diversity and diverse perspectives and helps its employees achieve an effective balance between work and home life and supports their efforts to have a positive impact on their communities.
The Global Labeling Compliance Manager is a member of the Global Labeling Centre of Excellence. This position will work within a collaborative and dynamic team where process improvement is considered a daily way of working. This role is responsible for global active monitoring, oversight, and continuous improvement of the end-to-end labeling process, including provision of reports and metrics to stakeholders to drive timely execution of labeling changes. This position partners with various Quality organizations to ensure labeling-related audit and inspection readiness for local operating companies (LOCs) and the Global Labeling Centre of Excellence (GL CoE). This role manages the quality event and deviation process in accordance with Company procedures. The manager ensures compliant, timely procedural documentation and contributes to resolution of issues.
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**Key Responsibilities**:
- Participates and/or facilitates the creation or revision, review and implementation of GL CoE procedural documents and training.
- Ensures timely completion of labeling-related investigations, CAPAs and associated efficiency checks within the GL CoE.
- Partners with GL CoE staff to ensure support for the GL CoE during audits and inspections and the management of labeling CAPAs. Contributes to support for LOCs during audits and inspections, as needed.
- Liaises and partners with stakeholders to ensure the end-to-end global labeling process is maintained and/or improved.
- Supports or manages labeling-related improvement projects of moderate size, complexity, and business impact.
- Ensures training of relevant partners on the end-to-end global labeling process.
- Participates in review of emerging new labeling guidance and guidance changes; ensures consistent implementation via procedure changes, as needed.
- Provides guidance for local labeling process, including alignment with global process, where applicable.
**Qualifications** Education**:
- Bachelor's degree or higher required, preferably in a scientific or business field.
**Experience and Skills**:
**Required**:
- 5-8 years of relevant experience (including 5+ years of pharmaceutical or health care industry experience) is required.
- An understanding of the end-to-end global labeling processes and experience associated with product labeling/packaging is required.
- Experience with global labeling guidance and regional/regulatory requirements is required.
- Working knowledge of management of change, document management, and training processes is required.
- Experience in the delivery of quality procedural documents or appropriate equivalent departmental standards is required.
- Understanding of complex labeling issues and the ability to translate them into required documentation in accordance with Company procedures (e.g., event, deviation, escalation, CAPA and efficiency checks) is required.
- Experience leading a team within a matrix environment to achieve shared goals in a time sensitive environment is required.
- Strong interpersonal, verbal and written communication, negotiation and partnering skills is required.
- Experience with business systems that support labeling processes, including but not limited to document management, event tracking, and change management systems is required.
**Preferred**:
- Knowledge of designing training and business aids to support business tools and processes is preferred.
- Experience in developing and crafting data analyses methodology and interpretation is preferred.
- Knowledge of process excellence, process improvement methodology is preferred.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
The base pay range for this position is $106,500 to $160,000. The Company maintains highly competitive, performance-based compensation programs. Under curren
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