Quality Assurance Director
Contract based role with fast growing biopharma based in Dublin
This individual will work as the EU Quality representative within the new business integration team on behalf of EU Quality Operations. The new business integration team will manage the integration of new business manufacturing (commercial & clinical), QP release, supply chain
operations and quality processes into the organisation.
You will have primary responsibility for the integration of the new business quality processes into the organization as well as supporting remediation of any associated compliance deficiencies. This leader will partner closely with other Technical Operation leaders especially External US QA Operations, QC, Validation, Compliance, Regulatory, PQM, and Supply Chain to ensure timely QP disposition of clinical and commercial products.
This individual will be responsibility for the execution and management of the local operating country (LOC) strategy in EU, Middle East, Africa, and Canada. This leader has responsibility for compliance to Good Distribution Practices and global standards for LOC's distributing small molecule, biologic and device Products.
This individual will be responsible for the successful and timely completion of goals and objectives associated with the integration of New business into the organization, LOC strategy and operations management, and implementation of license integration strategy. This position will have direct reports in EU and Canada in the LOC organization.
The position may require approximately up to 30% travel.
This position is responsible for the Integration of new business quality processes into the organisation and to ensure implementation of an effective process for Quality oversight of contact manufacturers, Packaging and labeling, QC testing, QP release and distribution of new business products which is consistent with established business processes and GMP/GDP standards.
Integration of new business quality processes and documentation into the organization batch records, specifications, deviations, complaints and change controls. Integration of new business batch release process into the operations. Oversight of the new business QP batch release to ensure continuity of supply. Approval of new business SOP's. Implementation and maintenance of Technical Quality Agreements. Implementation of remediation plans to address new business compliance deficiencies
Integration of New business manufacturing, testing and Distributor into the organisation .Supporting all cross functional integration team activities.
Ensure that there are appropriate new business QP/RP/QA resources to ensure systems and communications are in place and in operation. Designing, implementing and improving EU Quality metrics and quality systems. Participate in New business integrations meetings.
Facilitating technology transfer, process scale-up, and process improvement for New business products. Implementing strategy to enhance and maintain Quality functions in the LOC region including support strategy for new market entry, due diligence, vendor selection, and product launches. Review of LOC position to fully understand the responsibilities and workload completed within the group and the challenges and opportunities that are present within the team.
Establish how best to support work in each region and how to align to other functions to ensure that all new and existing markets and products are fully supported from both a technical,
logistical and cultural perspective. Host inspections of health authorities, internal audits, partner and third party audits and manage response management in LOC. Lead the LOC Team to manage and oversee all aspects of the LOC organization's performance, ongoing Quality initiatives and Operational Excellence. Supporting potential WDL license consolidations in EU.
To represent EU Quality for the integration of New business. Provide technical support to critical New business investigations to facilitate QP disposition. Access to senior management. Access to any documentation required to fulfil integration responsibilities . Keep Sr Management informed of progress of the integration of new business into the organisation. Approve Technical Quality Agreements and SOP's. Coordinate and attend authority inspections of New business as the Quality representative
Represent the LOC operations are quality management meetings.
- degree in chemistry, biology or a related discipline. 1O+ years’ experience working in Quality Assurance as a Qualified Person performing disposition of tablets, parenterals (biologics), and devices. Thorough understanding of quality systems, cGMPs and GDP's. Experience working directly with CMO's to resolve significant compliance deficiencies associated with downstream process ing of biological products. Interpersonal skills and professional skills to interact with contractors. Must be able to prioritize and multitask in a stressful environment. Must be able to read, understand, speak and write legibly in English
- Certified Quality Auditor
Cv to email@example.com 01 2302400