CHC Distributor Quality Lead AMEA and China

Mission & Tasks:

• Support the Business Teams in charge of the management of Distributors by ensuring an appropriate quality oversight/level of control on those Distributors, during the selection phase throughout the routine operations of the contracted Distributors.
• Ensure that appropriate quality systems, processes and tools as well as communication channels are in place within CHC/Opella Healthcare organizations to efficiently manage internally quality matters reported by the local Distributors, in compliance with the Global Quality standards and applicable GxP regulatory requirements.
• Ensure that the CHC products distribution and all related post-marketing activities (when CHC/Opella Healthcare is Marketing Authorization Holder (MAH)) are executed by the local Distributors in compliance with the international and local regulatory requirements, to ensure patient/customer safety and to support business priorities.

Key Contributions & Activities:

• Assess the level of risk, from a quality standpoint, of the Distributor, based on the scope of contracted services:
  • Provide guidance/support (as needed) to the Distributor to complete the quality evaluation questionnaire.
  • Analyze the completed questionnaire and provide to the Business Teams in charge of the Distributor a conclusion in relation to the quality risk level.
  • Coordinate execution of audits, or perform audits.
• Manage/ensure the quality performance of the Distributors:
  • Establish and maintain the Quality Agreement with the distributors.
  • Coordinate the quality assessment, qualification process and/or the audits of the Distributor, during the selection process as well as routinely.
  • Follow-up the release of the audit reports, analyze the outcomes and ensure that efficient action plans are defined and followed-up until closure by the auditors.
  • Ensure timely update of the Global tool for Quality management of third parties with the relevant documentation (such as Quality Agreements, Audits reports, …)
  • Ensure regular adequate communication to CHC Distributors Business teams on the quality performance of the Distributors.
• Support the Distributor Markets Quality Head in the interface between the Distributor and the Opella Healthcare / Internal manufacturing / External manufacturing units supplying CHC products. Manage/ensure management internally of quality matters reported by the Distributors, with associated information sharing flows & communication channels.

When needed, organize and deliver training of the Distributor on CHC/Opella Healthcare quality processes.

Support the appropriate quality organization, systems, processes, tools, ways of working and governance to ensure an efficient & timely:

• Escalation of quality events and management of quality alerts
• Quality management of:
  • Product quality complaints
  • Recalls and destruction of returned goods.
  • Logistic incidents/damages with potential impact on the quality, safety and efficacy of the CHC products (such as temperature excursions).
  • Suspected cases of counterfeit or falsified CHC products
• When applicable:
  • Market Batch release
  • Importation QC testing
  • Redressing/Repackaging operations and corresponding release of the repacked batches

• Act as Quality support within CHC/Opella Healthcare to be informed by the Distributor:
  • Upfront of any inspection with CHC products and services in scope, as well as of inspection outcomes with potential impact on the quality services provided by the Distributor to CHC/Opella Healthcare
  • Of any intention to subcontract any quality activities or services in the scope of the contract, in order to get CHC/Opella Healthcare quality approval beforehand.

• When the Distributor, as the local Marketing Authorization Holder (MAH) of CHC products, supports requests to audit the “SANOFI/CHC manufacturing sites”, supports the coordination of this audit internally
• Support global Quality projects as per assignment from supervisor.
• Contribute to the design and continuous improvement of quality systems for Quality Management of Distributors.

Scope of Responsibility:

Management Responsibilities:

The role holder reports to the CHC Distributor Quality Head.

Latitude of Action:

The role holder is required to work autonomously and to take decisions in line with Global Quality Policy, Standards and Processes. The role holder has strong compliance mindset; Results-driven, can-do-attitude, solution-oriented, business-focused, change-agent, patient centric mindset, resourceful, and innovative.

Role Impact:

lt is a key role requiring coordination & constant interactions with the Business Teams in charge of the Distributors to ensure compliance by the Distributors with the quality requirements applicable to services & products in the scope of the Distribution agreement.

Scope:

The role holder provides operational / hands-on support of Quality topics to the Business Teams in charge of the Distributors, with CHC Science Hub functions, with Supply Chain Management at Global/regional/local levels and interacts as well as with other CHC Global Quality peers and colleagues from CHC Global Quality “Upstream” organizations.

Required skills and Experience:

Specific Working Experience: Practical and solid experience of minimum 3 years of Quality Management experience in health-regulated industry, ideally in the Distribution area. Basic knowledgein Regulatory Affairs, Medical, Pharmacovigilance domains. English Fluent. Cross-cultural interactions with teams in various countries. Experience as Project leader. Qualification and experience as GDP / GMP auditor preferred.

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