As a Reagents Validation & Process Compliance Senior Manager you will develop, implement and ensure practical, innovative, sustainable, efficient quality / regulatory compliance (International Standards Organization (ISO), Food and Drug Administration (FDA), End User (EU) for Reagents Manufacturing (Industrialization, Engineering / Maintenance, Media Production and Card Production) to meet local / global requirements.
- Manages, coaches, develops, trains, directs and supports team of approximately 4 direct reports.
- Corrective and Preventative Action (CAPA) ownership for Reagent Manufacturing; other CAPA roles such as but not limited to lead CAPA investigator for Reagents Manufacturing, as required, to ensure CAPA’s are completed on time, are effective.
- Validation – develop and implement a robust, efficient and compliant risk based validation lifecycle program for Reagents Manufacturing. This includes but is not limited to developing, approving and executing risk based, compliant, efficient and robust process, equipment and computer system validations on time/schedule.
- Risk Management – ownership for updating and maintaining process risk assessments for Reagents Manufacturing to ensure horizontal and vertical alignment with Critical Process Parameters / Critical Quality Attributes (CPP/CQA) documentation as well as other related documents such as but not limited to drawings / specifications.
- Investigations – completion of root cause analysis investigations which may include but not be limited to customer complaints and/or material discrepancies, as required.
- Change control – develop and implement a robust change management program for changes in Reagents Manufacturing; additionally, develop and/or review scientific rationale for changes made in Reagents Manufacturing, as required.
- Procedures – develop, implement and own streamlined procedure development and maintenance, as required, using effective procedure development writing methods and aids.
- SME, liaison and coordinator across all of Reagents Manufacturing for operational quality / compliance items in support of daily operations and projects, including identifying and driving continuous improvement.
Scope and Resources Accountability, Typical Performance Indicators:
- Scope and Resources Accountability: approximately 4 direct reports
- Financial Indicators (revenue, budget, etc.).
- Key Performance Indicators (KPIs): on time validations and Corrective and Preventative Action (CAPA)’s, CAPA effectiveness rate, number of customer complaints, number of audit observations; conformity with quality standards and procedures.
- Key Contacts (internal/external) and Interfaces: Director, Reagents Manufacturing; Director, Industrialization; Senior Manager Maintenance and Engineering; Production Manager Media Production; Production Manager Card Production; Trainers; Senior Manager Quality Assurance; Senior Manager Quality Control.