Job
Description
As the Head of Global Quality at our company, you will play a crucial role in leading the development and execution of quality assurance strategies aligned with our long-term goals. You will partner closely with the Chief Technical Officer (CTO) and the Leadership Team to ensure robust quality management systems, regulatory compliance, and continuous improvement in operational performance. **Key Responsibilities:** - Establish best-in-class quality goals, perform quality metrics trending, apply problem solving, system improvements to meet these target levels of quality. - Lead and manage the quality teams with oversight in operations at all manufacturing facilities with a continuous improvement focus. - Build and inspire a team of QA professionals through training, mentoring, and management in the adoption of new processes and tools. - Collaborate with business units to develop quality targets for new and existing products. - Manage quality projects and activities resulting from site consolidations and acquisitions. - Collaborate with the Quality Management System group on simplification, harmonization of quality systems, and implementation across Operating Companies. - Ensure the effectiveness of the Quality System across all manufacturing sites and Contract Manufacturing site. - Implement and follow an effective Vendor/Supplier development process. - Drive recruitment activity and assure the ongoing professional development of direct reports and the overall company quality organization. - Establish standards/metrics to facilitate exponential growth while adhering to quality standards and regulatory guidelines. - Participate and contribute to regular functional meetings such as Supply Chain, Operational Excellence, and Sourcing, R&D. - Lead QA teams in global sites responsible for Audit management, Document control, Deviation, Change Control, CAPAs, Complaints, Adverse event reporting, final product release, and other QA related activities. - Promote customer-centric initiatives to improve customer satisfaction. - Use CAPA system to systematically improve processes and organization capabilities. - Ensure sites are prepared for Regulatory Agency Inspections and participate in the planning, review, and approval of GMP/GDP related issues of new or remodeled facility layouts. - Provide and participate in training efforts of Shalina sites on a need basis. - Provide advice and support to alliance partners, service providers, and the central distribution center to ensure compliance with Quality requirements. - Give immediate support in the form of possible corrective actions during audits and Compliance. **Qualifications Required:** - M.Pharm / B.Pharm / Master's in Science preferred. - 15+ years of leadership experience in Quality Assurance, preferably within the pharmaceutical or life sciences industry. - Strong understanding of Regulatory landscapes in semi-regulated markets and international quality standards. - Exceptional commercial acumen and strategic business insight. - Excellent consulting and communication skills (oral, written, interpersonal, presentation) with the ability to influence senior stakeholders. - Strong personal credibility and interpersonal skills with the ability to build trusted relationships with senior business leaders and teams alike. - High level of integrity and dependability with a strong sense of urgency and results-orientation. - Experience working cross-culturally and cross-functionally with diverse colleagues. As the Head of Global Quality at our company, you will play a crucial role in leading the development and execution of quality assurance strategies aligned with our long-term goals. You will partner closely with the Chief Technical Officer (CTO) and the Leadership Team to ensure robust quality management systems, regulatory compliance, and continuous improvement in operational performance. **Key Responsibilities:** - Establish best-in-class quality goals, perform quality metrics trending, apply problem solving, system improvements to meet these target levels of quality. - Lead and manage the quality teams with oversight in operations at all manufacturing facilities with a continuous improvement focus. - Build and inspire a team of QA professionals through training, mentoring, and management in the adoption of new processes and tools. - Collaborate with business units to develop quality targets for new and existing products. - Manage quality projects and activities resulting from site consolidations and acquisitions. - Collaborate with the Quality Management System group on simplification, harmonization of quality systems, and implementation across Operating Companies. - Ensure the effectiveness of the Quality System across all manufacturing sites and Contract Manufacturing site. - Implement and follow an effective Vendor/Supplier development process. - Drive recruitment activity and assure the ongoing professional development of direct reports and the overall company
