Quality Manager

Job Description The Role: The Quality Manager will ensure that the site meets GMP, compliance and regulatory standards. You will maintain the site in compliance with IS0 9001 standard are manufactured under GMP regulations and all shipped pharma products are of good quality. How You Will Make an Impact: Ensure EHS compliance and continuous improvement in EHS performance Ensure department goals and KPIs are aligned with site objectives Develop budget plans following a zero-based approach and manage Quality costs Provide site strategy for quality management Be the Management Representative for obtaining and maintaining quality certifications (ISO 9001 etc.) Oversee execution of raw material and finished good testing and COA generation Provide site strategy and procedures for maintenance of analytical data and document control Provide strategy for in-process quality control Oversee laboratory, analytical equipment and facilities Review customer specifications and ensure that processes are capable Analyze and lead improvement efforts related to process capabilities (CpK) of production processes to eliminate product defects Focal point for site customer complaint investigation and response processes Ensure EHS compliance and continuous improvement in EHS performance Assure a compliant quality operation (incl. e.g. Responsible Care, ISO 9001/14001) Manage QA aspects of the site MOC process for pharma and non-pharma operations. Create and improve customer engagement touchpoints for matters related to product quality and regulatory compliance Assess and evaluate supplier quality processes to ensure alignment with SI quality standards; apply corrective action accordingly Oversee audit and investigation processes related to quality and for