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.

Competencies:

• Highly independent with compliance mindset.
• Pragmatic, strong common sense, reactivity and ability to act quickly.
• Open-minded & result-oriented team player.

• Basic understanding of Health Authority regulations.
• Ability to collaborate in a rapidly evolving environment.
• Excellent organizational, analytical and collaborative skills.
• Ability to clearly communicate in English (oral, written).

Qualification:

Pharmacists, holds a degree in life science-related field, PhD, PharmD.

Experience:

7-15 years of experience in pharmaceuticals or biologics or a related industry in areas of Good Manufacturing Principles (GMP) and Good Distribution Practices (GDP).

At least 3 years of quality experience in Good Distribution Practice (GDP) including recall management, alerts and complaints.

Basic understanding of Medical, pharmacovigilance and regulatory affairs activities.