Distribution Operations EMEA/ APAC Manager

Great opportunity of 12 months for a leader in the pharmaceutical industry as Distribution Operations EMEA/ APAC.

Responsibilities:

• Responsible for supporting the maintenance of the Quality Management System for EMEA/APAC.
• Hold role as interface with In-Market Quality and Global Supply Chain Compliance colleagues.
• Prepare, update, and approve procedures in accordance with GMP/ GDP and company requirements.
• Change control, non-conformance investigation, supporting internal/ corporate and health authority inspections, supply chain projects, compilation of metrics and document management.
• Manage all documents in accordance with records management procedures and data integrity requirements.
• Serve as the Local Process Owner in the execution of QMS activities, compliance initiatives, best practices, and industry standards per implementation strategy.
• Monitor deviations, internal and external change controls and CAPAs, standalone actions to ensure progression and timely closure.
• Develop responses to internal audits and ensure appropriate implementation of corrective actions as required.
• Support and participate in local initiatives or projects to increase compliance and reduce costs/ non-conformance.
• To review executed forms (destruction, redeployment) and ensure GDP requirements are met.
• Management of complaints, ensuring they are dealt with effectively.
• Escalate any complaints, reported defects, reported falsified medicinal product.
• Lead technical or risk assessment exercises where needed including contracted activities which may impact on GDP.
• Execute ad-hoc reviews of processes and procedures and provide support in collaborating with Compliance Excellence on executing the self-inspections per defined intervals) and implement corrective actions as necessary.
• Ensure that the quality,safety and traceability of medical products are maintained within the supply chain.

Qualifications:

• Bachelor’s Degree in a Scientific/ Technical discipline required
• A minimum of 5-8 years’ experience in a Quality or compliance role within the Pharmaceutical industry, most specifically in relation GDP.
• Formal certified GDP Training on Good Distribution Practice of Medicinal Products for Human Use
• Up to date knowledge of relevant pharmaceutical legislation and GDP.
• Ability to apply GDP regulations and international guidelines to all aspects of the position.
• Demonstrated knowledge and application of industry regulations as they apply to quality, including those of HPRA, EMEA, FDA and other authorities.
• Excellent interpersonal and Innovative skills
• Ability to operate as part of a team is critical.
• Excellent communication skills both written and verbal
• Attention to detail, adaptable and flexible, results and performance driven
• High customer orientation, excellent interpersonal, communication and teamwork skills
• Ability to build trustful relationships, engage and influence stakeholders at all levels, including market and GPS leadership
• Excellent analytical, organizational, and problem-solving skills