Lead the Quality Assurance teams responsible for the Medical Franchise manufacturing outside the US, delivering the strategic, compliance and business objectives of the function, with primary responsibility for developing & leading quality within operations and other business functions.
·Identify opportunities for efficiencies, risk-based approaches, and competencies aligned with GQO and 1A customer strategies.
·Collaborate closely with partner areas including Procurement, AO, Operations, and other Quality Leadership to develop and implement an organizational vision, structure, and strategy to provide clear lines on communication accountability, and responsibility to support the growth of the business.
Work within the Manufacturing Quality Assurance structure, in a leadership capacity, having responsibility for quality related activities including, but not limited to the following:
Ensure that the organisation’s conformance and commitment to producing products meets or exceeds customer requirements and the relevant regulatory standards.
Accountable for recognizing opportunities to maximize and increase efficiencies through continuous improvement, manufacturing-related changes, lean activities, and leverage across the business.
Responsible for providing technical and scientific support including in the areas of site sterilization and microbiology execution, metrology technical expertise and process development, and laboratory testing as applicable.
Lead and / or partner in deployment of manufacturing & automation systems to optimize manufacturing processes, validation, supply chain, and business operations such as MES, CMMS, SPC, automation control and integration to key business systems such as ERP, PLM & PDM
Responsible for establishing and maintaining compliance with global quality system requirements.
Ensure the site(s) maintain continued certification to all regulatory bodies. Responsible for interfacing with regulatory agencies in internal and external audit programmes such as Corporate, notified body & FDA audits.
Responsible for quality control processes including acceptance activities, in-process controls and monitoring, final inspection and verification, final product release, and clean room and laboratory environmental control.
Ensure effective management and control of product / process deviations for all released product and for the implementation of effective corrective action when non-conformances arise. Leadership over operations at site(s) in managing product & patient risk.
Responsible for supporting the execution of product transfers.
Build a high performing QA team and wider community to maximise value from current QA processes. Shape an optimum operating model to standardise business processes, leveraging SMEs while driving consistent & sustainable QA processes.
Champion a positive employee environment by promoting open communication, engagement and development of team members. Promote a culture of trust, flexibility, teamwork and inclusiveness, ensuring all relevant Quality functions (e.g., Shared Services Quality, Supplier Quality) are included in decision making processes as part of continuous improvement, problem solving and projects.
Demonstrate expertise in leading organizational change and cultivating innovation for the successful execution of large-scale operational transformations within a global context.
Engage in plant network strategy evaluation and deployment. Develop a QA PT roadmap aligned with GQO strategy for sustaining growth by identifying future opportunities for leverage, capacity/capability, and future business benefits.
Responsible for ensuring site(s) maintain adherence to Quality KPI performance indicators, taking timely action to address adverse trends and deviations, and continuously monitoring and partaking in global forums to assess opportunities for improvement.
With global alignment, develop a quality planning pipeline of quality improvement activities including initiatives to increase product quality, NCR & CAPA resolution, reduce cost, decrease in-efficiencies and improve risk management.
Has a track record of building high performing teams that deliver tangible results and achieving key performance indicators. Has strong people leadership skills to inspire and guide teams through operational transformation.
Has the ability to adapt to changing business environments and technological landscapes, supported by strong influencing and negotiation skills. Is highly attentive to customer needs and oriented towards delivering exceptional service.
Education
Bachelor’s degree (Engineering or Science). Master’s degree preferred.
Successful, 10+ year track record in a GMP organization with 5+ years leading teams
Experience in multiple areas / sites/ positions in the quality organization is advantageous