Operational Excellence Coordinator
Operational Excellence Coordinator
Posted on :
06-04-2025
Employer Active
1 Vacancy
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Job Description
Description
Job Description
Title:
Operational Excellence Coordinator
Department:
Cell & Gene Therapies
Site:
Global
Reportable to:
Senior Manager Operational Excellence Cell & Gene Therapies
Line Management Responsibilities:
No
Main Purpose:
In this role the candidate is responsible for investigating CGT Issues and tracking compliance of the CGT function at Marken. This role will also provide support to other roles within Marken such as our Senior Manager of Operational Excellence and all the CGT. Leads as required and will interface with other members of the wider Marken family to ensure consistency in our accountability to our CGT clients.
Main Duties and Responsibilities
- Act as a lead investigator. Perform root cause analysis close deviations and effectiveness checks.
- Provide guidance on investigations to coinvestigators and operational staff.
- Issue escalation and mitigation. Identify trends within the investigations team and report findings to CGT management and quality CGT staff.
- Create and expedite Client Incident Report (CIRs) Investigation summary reports for the clients. Actively participate in calls with customers if required.
- Identify and suggest robust Corrective and Preventative Actions. Analyze and highlight issue and CAPA trends. Support assignment of proper corrective actions.
- Collaborate with Marken Vendor and Logistics Service Provides to complete investigation and CAPAs.
- Track and communicate process improvements in the region including Standard Operating Procedures.
- Lead and/or support and facilitate regional continuous improvement events
- Perform calculation data collection in support of Marken operations global initiatives and management reviews.
- Identify inconsistencies and/or deficiencies in the QMS and report them to CGT management and quality CGT Staff
- Identify any process gaps that were observed in Markens procedures during the investigation.
- Work closely with local quality coordinators Quality Managers and Directors.
- Support other Operational Excellence activities as needed.
- Perform weekly metrics on CAPA system (number of issues and CAPAs completed per week number of issues completed overdue issues effective versus ineffective).
- To do weekly follow up of the issues and CAPAs.
- Support QA/QC activities as needed.
- Additional responsibilities may be required to support the CGT Driver Excellence Program
General
- To adhere to all company Policies at all times.
- To undertake any other reasonable duties at the request of the Line Manager.
- Travel as required for the job function.
Qualifications:
- University degree in science or supply chain preferred or equivalent practical experience.
- At least 35 years of experience in pharmaceutical logistics
- Knowledge in Pharma Medicine or Logistics.
- Excellent communication and cross functional collaboration skills
- Experience in Training other teams and external vendors
- Comprehensive knowledge of pharma industry specializing in Cell & Gene therapy.
- Comprehensive knowledge of regulatory requirements concerning cryogenic transportation and commercial .
- Excellent interpersonal verbal and written communication skills.
- Knowledge of cold chain supplies and logistics in healthcare settings
- Knowledge of cryogenic storage and transportation of Cell & Gene products in both clinical and commercial stages.
- Ability to manage multiple and varied tasks.
- Must have an eye for detail and the ability to think on their feet.
- Organized and skilled in tracking with the ability to multitask and problem solve.
- Fluent in English
- PC and Microsoft products experience a must.
Physical Requirements:
None
Required Experience:
IC
Employment Type
Full-Time
Key Skills
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