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The purpose of this position is to provide administrative and technical direction to Quality Assurance Product Release, Document Control and Learning & Development groups.
Scope of Quality oversight includes the approval, control and security of master data, procedures, records and reports at the Fort Dodge site. The position oversees the program of document retention and archival and manages the Learning and Development Success Factors Team. This position is the site master data steward for all controlled quality documents including product and material specifications, batch records, outlines of production, SOPs, electronic system records including inspection plans and item master documents. This position is also responsible for Batch Release (in-process and finished product).
Manager, Quality Assurance is responsible for identifying and implementing new quality initiatives, systems and strategies to drive continuous improvement and innovation to sustain compliance and competitive advantage.
The Quality Manager shares successful programs with other sites in Elanco network in order to build cross site processes.
- Implements SOPs to align with current regulations, Elanco Global Quality Standards and Elanco Functional Procedures.
- Provides quality oversight to the department and site regarding compliant documentation approaches involving change management, good documentation practices and records retention.
- Responsible for providing technical guidance, training and oversight for the department and its members.
- Prepares annual expense budgets for QA Document Control and monitors to stay within prescribed limits.
- Present escalation topics impacting the area of oversight at Elanco Assessment Committee (EAC) meetings
- Assist with internal, regulatory or Corporate audits to ensure compliance with domestic and international regulations, quality requirements and guidance documents.
- Assist with audit responses and completion of assigned CAPAs by target due dates.
- Provides input into the development of the Site Quality Plan.
- Overall Department operates in an efficient manner, generating quality and timely data within an atmosphere which promotes staff development and growth.
- New or upgraded procedures and policies are created and implemented in a timely manner.
- Successful regulatory, third party and EGQCA audits/inspections
- Budgets are appropriately set to ensure company resources are used efficiently and appropriately.
- Successful execution of the Quality management system to identify and respond to product, compliance and quality system risks.
- Routine inspection readiness of documentation, records and reports
- Oversee the creation, maintenance and approval of inspection plans and specifications within the site electronic resource planning system (ERP, SAP or other)
- Provides ERP system troubleshooting and leads in developing end user procedures and work instructions supporting the ERP system.
- Ensures site users of the system are fully trained and qualified for the respective security role.
- Ensures that only quality personnel have system access to perform lot status changes.
- Ensures the accuracy and compliance of controlled records against the approved registered outline of production
- Effective and agile change management of documents and systems.
- Ensures availability and accuracy of quality records to support production and laboratory operations.
Document Change Management
- Champions electronic system master changes (new versions, rollovers, cut-overs)
- Serves as quality custodian for any changes to approved electronic records
- Maintain site controlled document systems,
- Develop and maintain standard operating procedures (SOP) and training operations on quality principles.
- Support strategic direction of site document management systems and process flow incorporating into Elanco quality system structure.
- Provide training and guidance to site on identification, reporting and implementing controlled change management.
- Compliance to applicable site procedures, EFPs and EGQS
- Effectively implements changes impacting approved documentation and records both manual and electronic.
- Proactively identifies risks and develops risk mitigation strategies
- Designs, manages and implements compliant documentation and records retention practices.
- Maintains contracts and quality agreements with third party records retention services.
- Fort Dodge operations are executed in compliance with site SOPs, Elanco functional procedures and Elanco Quality standards.
- Efficient retrieval of documentation during investigations, audits and inspections
- Design of system ensures efficient retrieval of quality data from system for metrics reporting purposes and quality trending.
- Manages, trains and qualifies employees performing critical in-process or finished product release functions.
- Proactively identifies areas of improvement with Good Documentation practices and leads site initiatives to improve compliance of manufacturing records
- Demonstrated improvement in right first time releases, minimizing number of times documents go back to production for corrections
- Responsible for oversight of training program for the site
- Coordinates with department management to identify required curricula and coordinates annual reviews of training curricula
- Ensures compliance with Elanco quality system requirements for training at the site.
- Completes own assigned training by target due dates
- Identifies professional development opportunities for self and team.
- Routinely monitors assignments in learning system to assure training is up to date.
- Employee training curricula is compliant with requirements per the job descriptions
- On time completion of training for the department
- Training sessions are effective and consistent with adult learning methodologies
- Training is completed on time and by due dates.
- Proactively identifies training opportunities and leads classroom facilitated training for the department and the site.
- Required training is completed prior to performing work
Deviations and CAPA:
- Conducts training of employees on investigation reporting requirements.
- Reviews department investigations for compliance to procedural requirements.
- Ensures cross functional team involvement for determination of appropriate root causes and CAPA
- Quality Issues are resolved promptly and thoroughly.
- Network collaboration and alignment with regulatory is achieved during the escalation, investigation and reporting of quality events
- On time completion of quality reports reflected in metrics; reports are clearly written and include the key elements required in investigations per the quality standard.
- Critical issues are reported and escalated within 1 business day of discovery.
- CAPAs are completed by target due dates.
- Actively identifies and leads project teams in alignment with site quality strategic direction
- Champions idea generation and solution development/process improvement.
- Provides data to support implementation and suggests new ways to apply existing knowledge.
- Displays respect and appreciation for individual differences; values contributions of others
- Significant working and theoretical knowledge is required in order to objectively assess procedures and determine the level of compliance, apply appropriate risk assessment and recommend improvements to improve compliance levels.
- Thorough and technical correct decision-making skills are required and in constant use in this position.
- Experience in department oversight (organizational, budgeting, strategy) required
- Good knowledge of statistics, databases, and quality principles.
- Ability to plan, schedule, organize, prioritize, and coordinate project activities.
- Makes routine decisions with limited guidance from supervisor.
- Recognizes and reacts to the significance of data/results.
- Written and verbal communication with cross-functional groups.
- Must be self-motivated and of high integrity
- Ability to use technical knowledge to solve problems.
- Ability to lead teams and manage performance to achieve results.
- Actively engaged in leadership and professional development of team members
- Demonstrated high ethical and professional standards with all business contacts in order to maintain Elanco’s excellent reputation in the community.
- Proficiency in relevant computer software programs associated with the area
- Demonstrates proficiency in lean/5S/six sigma methodologies
- Bachelor’s Degree in Biology, Chemistry, Biochemistry, Biopharmaceuticals, Business Administration, Economics, Engineering or IS/IT.
- Minimum of 10 years in a regulated pharmaceutical /vaccine manufacturing environment.
- Must demonstrate ability to work and communicate with diverse groups across the organization at all levels on a routine basis, locally and globally.
- Well versed in all regulatory requirements, inclusive of cGMP/GLP and BI requirements.
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status