Quality Manager

 

Quality Manager works under Quality Operations team for the region (Europe and MEA) is responsible for the following:

*To manage and monitor the quality oversight of our product portfolio; ensuring the necessary quality activities, assessments, and monitoring are effectively conducted by our network of warehousing and distribution partners and GxP local service providers

* To work with warehousing and distribution partners and GxP local service providers in support of the implementation of established continuous improvement programs.

* To collaborate across functions (Commercial, Supply Chain, Regulatory Affairs, Medical Affairs etc), creating a more collaborative quality function, and drive a quality mindset throughout the organization.

* Provide GxP quality operations advice and support MEA commercial entities to ensure its compliance to market regulations and achievements of its business objectives, including the following areas:

• Quality oversight of Contract/External Manufacturers (CMO/EMO)/3rd party logistics providers/Distributors to ensure the relevant quality processes have been conducted and are not duplicated by iNova
• To write, review &/or authorize Quality documents and procedures as defined e.g., SOPs, WIs, forms, PQR, Deviation and Quality investigation reports in accordance to Documentation and Record requirement.
• To maintain and manage Quality Management System (QMS) e.g., Change Control, Deviations & CAPA, Customer Complaints, including associated Metrics as part of performance monitoring
• To support due diligence checks for new external contract manufacturers, new products and support external audits as required
• To support the maintenance and improvement of the quality system.
• To ensure the implementation of Self inspection and support audit conducted by external party (Health Authority).

 

Key Accountabilities & Performance Indicators

The following outlines the accountabilities and deliverables of the Quality Manager in the Quality Operations team:

1- Quality Oversight 

• Work in collaboration with contract/ external manufacturer, and internal functions to ensure EMO partners conduct the required quality oversight, through OOS/NCR/ Deviation and CAPA, Change Control and routine stability testing monitoring, on time and in compliance to GMP and applicable standards
• Work in collaboration with Logistic Service Providers, GxP Service Providers and internal functions to ensure consistent quality oversight and on time compliance record closure on Deviations investigations, CAPA and Change management.
• Ensure customer complaints from Customers and Logistic Service Providers are managed within the SOP agreed timeframes.
• Perform oversight of market release process with Logistic service providers as per required to ensure batch right first time in accordance to agreed timeline (< 3 days) including for the returned to saleable product when required.

 

• Manage all logistic deviations with Logistic Service providers to ensure compliance to markets’ requirements.
• Overseas, review and approves all Secondary repacking operations with Third Party Repackers to ensure it complies with GMP requirements prior to release.
• Monitor the quality performance of logistic services providers and GxP service providers as per agreed KPIs metrics and escalate to senior management on any adverse trend.
• Support internal and external audit activities to ensure audit findings are closed within the agreed timeframes.
• Support recall management with the local commercial entities’ stakeholders and logistic service providers.
• Support training program to ensure personnel related to GxP process obtained the GDP and required training they required including to provide training to Logistic services providers if required to ensure iNova QMS requirements is understood

 2-Collaboration and stakeholder management

• Ensure implementation of iNova Quality Management System and GMP requirements at country level driving a quality mindset across operations.
• Ensure effective, overall quality management and continuous improvement of supply chain activities in MEA Commercial entities.
• Ensure timely and effective escalation or quality incidents and provide the necessary analysis to understand and escalate issues which have the potential to impact supply or iNova's reputation as a Marketing Authorization Holder (MAH) and distributor of quality products and when necessary direct Commercial entities to manage incidents via the Critical Action Committee (CAC) process.
• Collaborates closely with the wider iNova organization to ensure quality activities are completed and in compliance to regulation requirements and SOPs.
• Takes initiative to support other functions in quality operations activities where relevant.
• Functions as an integral part of the Quality Ops team.
• Coordinate with local/regional Regulatory teams and Distribution Center site readiness for Health Authority inspections and proactively manage interactions and commitments to Health Authority (HA).

 

 Qualifications, Skills, and Experience

• Minimum requirement is a tertiary qualification (BSc or equivalent) in chemistry, pharmacy or a related Science or Engineering discipline.
• Min. 5 years in the pharmaceutical/ medical device industry with at least 3 years of QA experience in the pharmaceutical or medical device industry. Experience in supply chain quality, manufacturing quality or quality organization in a commercial business
• Working knowledge of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), deviation management, CAPA, change control and documentation management in a pharmaceutical / medical device industry
• Good understanding of the Quality Management System (QMS)

 

Personal Attributes

• Strong customer focus (with respect to internal and external ‘customers')
• Experience in leading change with good communication skills.
• Continuous improvement mindset
• Ambiguity tolerance