National Quality Manager - South Africa & Kenya at World Courier

POSITION SUMMARY:
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 Process).
• To lead the in-country Quality teams to review, support, and perform document control / filing of Local internal guidelines. To update local guidelines for quality related processes.
• To identify along with local team, the need of local procedures and implement Local internal guidelines in accordance with Depot or Transport operational and technical needs and local regulations respectively.
• To support relevant Line Managers in having all in-country World Courier personnel properly trained on time to perform their duties.
• To act as a first contact with regional / global QA Managers whenever required in order to revise and define Quality/ Technical Agreements with local Clients/ Sponsors.
• To provide training on GxP (Good Manufacturing, Clinical, Storage, Distribution and Documentation Practice) requirements, to all in-country World Courier staff.
• To lead the local quality team to carry out the Suppliers Evaluation Program in accordance with internal guidelines, including local suppliers approval / rejection.
• To review and authorize the change of product status following client instructions and within the scope of applicable Internal Guidelines.
• To act as a first contact for the Country Managers for quality related topics.
• To ensure that the different service lines, i.e. transport, clinical trial and commercial storage, are adequate represented during local and global meetings (e.g. local management review) as well as local and global projects and initiatives.
• To lead the in-country Quality Departments to support any changes/developments initiated by the Regional /Global Quality Management
• Any other quality responsibilities assigned by Regional/Global Quality Management.

What your background should look like
EXPERIENCE AND EDUCATIONAL REQUIREMENTS:

• Advanced student qualification (intermediate graduation, 1st state exam, or equivalent) in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology and related fields; or in the absence of such qualification evidence of adequate knowledge in the working field
• Detailed understanding of Quality Management processes (e.g. ISO 9001)
• Advanced GxP expertise (e.g. local GMP, GDP and regulatory aspects)
• 4 to 5 years working experience in Quality environment.
• Preferred - operational background in World Courier processes

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

• Fluency in local language and adequate English skills
• Excellent interpersonal and communication skills
• Able to take initiatives and responsibilities
• Ability to view different topics with an open mind and provide constructive suggestions
• Advance computer skills (i.e. Microsoft office suite)
• Excellent technical, organizational, planning and team working skills