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.
BS in Chemistry, Biology, Biochemistry or Chemical Engineering
10 years Industry Experience to include:
Developing validation programs, including protocol development and execution in process, equipment and computer system validations using a risk based approach.
Developing streamlined compliant change control processes including engineering drawing control
Strong knowledge of automated systems such as but not limited to Distributed Control System (DCS) , Programmable Logic Controllers (PLC), Manufacturing Execution Systems (MES) along with record retention and electronic signature.
Extensive knowledge of domestic and international regulations and industry standards.
Surveillance of industry trends and guidance for industry.
5 years Management Experience /Skills and Qualifications:
Project management skills including use of Microsoft Project.
Ability to work cross functionally inside (engineering, Industrialization, manufacturing) and outside (quality, R&D, etc.) of organization.
Ability to transfer knowledge through documented systems and/or training.
Lean / Six Sigma
bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity.
A world leader in the field of in vitro diagnostics for 50 years, bioMérieux is present in more than 150 countries through 42 subsidiaries and a large network of distributors. In 2014, revenues reached €1.698 billion with 88% of sales outside of France. bioMérieux provides diagnostic solutions (reagents, instruments, software) which determine the source of disease and contamination to improve pati...ent health and ensure consumer safety. Its products are used for diagnosing infectious diseases and providing high medical value results for cancer screening and monitoring and cardiovascular emergencies. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.