National Quality Manager
1 week ago
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- What you will be doing
World Courier
- Our commitment to People, Quality and Innovation means we deliver career opportunities that few others can match. From our beginnings 50 years ago couriering time sensitive high importance documents to today’s cutting edge logistics solutions for Cell & Gene Therapies that save lives, we now have over 3,000 employees at 140 offices in more than 50 countries worldwide and are part of Fortune 10 corporation AmerisourceBergen.
- #INDWC
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- Under general direction of the Global Quality Department and Country Manager, plays an important role to assure the local compliance with World Courier policies and procedures. Responsible for fulfillment of Quality related activities including final approval of local protocols and reports. The associate may provide support to other depots or offices in specific tasks under the supervision of the Regional Quality Management. Provides quality expertise to CSS depot team and transport team. And uses that expertise to monitor and improve quality. The Quality Manager may have regulatory responsibility in front of the local authorities.
- The Quality Manager will manage a team of the local quality associates.
- PRIMARY DUTIES AND RESPONSIBILITIES:
- To monitor and ensure that all Company Policies are followed by World Courier Depot and Transport Offices in the assigned countries
- To follow Quality Policies and Procedures, interpreting and implementing Quality Standards
- To manage the actions to be taken with other QA representatives belonging to in-country Quality department.
- Assist and permanently participate with regional / global QA Managers in ensuring and increasing Quality improvement at the Depot and Transport Offices (development and preparation of the depot and transport offices, operations and staff).
- To participate in the CAPA and Complaint process, including reporting to global QA any deviations or potential problems, participate in the investigation, support with the generation of reports, and tracking deviations and actions as described on the specific internal guidelines.
- To provide ongoing assistance to Depot and Transport personnel regarding External Quality Audits, Visits and Regulatory Inspections.
- To act as first line contact in order to inform the company about regulatory updates that might impact World Courier service.
- Assure that World Courier Depot License(s) as well any other regulatory documentation is/are properly in place and updated.
- To assist External QA Audits or Clients Prospects, keeping the audit and visit reports for each client and following requirements consistent.
- Manage the quality team to prepare all required documents and information to present during External Audits at the Depot and transport offices, ensuring that a World Courier Confidentiality Agreement has been signed.
- To ensure that clients are contacted by the Quality Department whenever required in order to communicate expansions, depot/transport office moving process, regulatory updates clarifications, etc.
- To manage the Self-Inspection Program in the countries.
- To overview that cleaning program is properly implemented and documented.
- Communicate to Management team and QA Department, along with Depot and /or Warehouse Manager and Depot Pharmacist, exceptional needs for the storage of products required by clients/ sponsors. To provide local regulation background to support Management and QA team decisions.
- To ensure that QA spot checks of the batch processing and final records related to the relabeling operation are conducted; document the Quality Department spot check appropriately.
- Ensure spot checks are performed (as described in WC internal guidelines) to other operative activities in order to monitor that WC procedures and protocol/program instructions are properly performed by depot staff.
- To support recalls and mock recalls conducted in the Depot In accordance with applicable internal guidelines.
- To act as witness during the destruction process for stored products, e.g. IMP/Clinical Trial Material or commercial products when required.
- Overview calibration, maintenance and qualification program at the Depot and/or transport office according to internal guidelines, supporting the facility representative and QA manager technical compliance.
- To review the information on the temperature periodic report for all temperature-controlled areas of the depot and Transport office.
- To become part of the Approval Team or Plan / implementation Team for any Change Control Management process in the country according to case specific requirements.
- Approve validation documentation (e.g. MARS, equipment, facility) and to assure that the validation is performed according to the Validation Master Plan.
- To clarify discrepancies and deviations from SOPs and study / client specific instructions, and implement Corrective and Preventative Action Plans in order to correct abnormal procedures (CAPA and Complaint Pr
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