Director, Data Integrity Qms Topic And Kn Owner, Digital And Data Quality

MSD

Carlow

Position Overview - Basic Functions & Responsibility. Essential function(s) includes, but is not limited to: The Director of Data Integrity (DI) supports Quality and GMP compliance activities relating to data integrity in the GMP and GDP areas for human health  products for firms in the internal network and external network.  Collaboration with development groups, the Merck Research Laboratories and external firm quality oversight groups will be required to ensure clear line of sight on DI requirements and deliverables. The Director will receive direction from the Director and Executive Director of DDQ.  Primary Activities. Primary activities include, but are not limited to: Owns the QMS topic for Data Integrity, including the maintenance of associated procedures, and development of new procedures as needed. Supports activities to ensure Quality Management System Standards reflect agency guidance and expectations on data integrity for GMP and GDP data processes. Supports the development of expertise in Laboratory, Manufacturing or other Quality Management System functions and systems related to DI requirements, controls, risk and risk mitigation by owning and running the Company’s-wide Knowledge Network for Data Integrity. Provides input to ensure computerized systems and paper systems to meet ALCOA / Data Integrity principles – including interim and long term controls. Supports / provides input into the internal audit program to identify and resolve potential data integrity gaps. Provides input to ensure that deviations related to DI are completely and comprehensively addressed. Provide support for on-site execution of DI assessment or remediation activities.                     Partners with relevant groups (e.g. MRL / Commercialization / external firm quality oversight groups) to ensure alignment of data integrity requirements.  Engages in data integrity investigations or initiatives to assure adherence to applicable regulations. Partners with relevant groups to ensure that quality systems are in place to enable effective data integrity controls (examples include assessment of systems and data processes, standard work, system standardization, training, playbooks and tools etc).   Support / lead risk assessments for data integrity controls and remediation. Assist with developing/overseeing development of Data Integrity Training for employees, including initial training, ongoing training and training to address identified gaps/enhancements.  Provides support to sites in preparation for, during, and in response to regulatory inspections that include data integrity focus. Ensures data integrity issues identified by sites or through agency inspections are assessed for network impact and effectively resolved. Note: activities are in support of internal or external firms generating GMP or GDP data. Required Education and Experience: BS degree in life science (e.g. Microbiology, Chemistry, Biochemistry), IT or engineering discipline. 12 years applied professional work experience in pharmaceutical quality, laboratory or manufacturing operations. Quality Assurance or Quality Control or IT or Operations experience. Strong working knowledge of computerized systems / IT and corresponding business processes. Understanding of Data Integrity regulations and requirements. Preferred Education/Skills. Demonstrated management/leadership skills. Strong skills at team facilitation, team organization and listening. Strong collaborative and communication skills to manage teams including ability to communicate effectively in multiple directions. Program/ project management skills. Strong in-depth understanding of Health Authorities regulatory requirements and compliance/quality requirements, especially as it pertains to data integrity. Comprehensive understanding of Quality activities and functions. Extensive experience in supporting regulatory inspections and/or performing audits. Experience executing Quality Risk Management Tools and principles. Training Material development and deployment. As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs. As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process. We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world. Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model. So, if you are ready to: Invent solutions to meet unmet healthcare needs, please apply today.

573 days ago