As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals’ lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco’s promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.
The purpose of this position is to provide administrative and technical direction to Quality Control personnel. Scope of Quality oversight includes Virology, Immunochemistry, Microbiology, Reference Qualification, Method optimization and Improvement, Stability, and Animal Testing. Supports testing for raw materials, in-process, finished product and stability samples, support R&D testing and investigational testing. Provides leadership and supervision to the Quality Control teams, ensure that staff receives appropriate training, coaching and professional development. Workforce planning and development – Ensure ongoing development to meet the changing work needs and technological advances. Strategic Focus – Work with teams to set departmental strategy and objectives. Ensure all direct reporting employees have a PM and Development plan and carry out the plans to meet objectives and responsibilities. Quality Control – Manage the quality control team to ensure that timely support to all relevant internal departments and external customers occurs. Ensure that all out of specification results are reported and investigated and adequately resolved. Maintain corporate and regulatory compliance as it relates to Quality Control. Compliance – Ensure that product testing complies with internal specifications and applicable regulatory requirements. Aid in audits and self inspections of quality control areas. Control and manage QC budget including preparation, monitoring and adherence. Director, Quality Control is responsible for identifying and implementing new quality initiatives, systems and strategies to drive continuous improvement and innovation to sustain compliance and competitive advantage. Director, Quality Control 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, sample control, laboratory systems and laboratory investigations.
- Responsible for providing technical guidance, training and oversight for the department and its members.
- Prepares annual expense budgets for QC 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 .
- Support R&D technical transfer activities.
- Effectively manage performance of QC Leaders and hold accountable for managing team performance
- 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, laboratory areas and personnel
- Clear performance expectations are set and team is held accountable to meet expectations.
- Oversee the maintenance and improvement of laboratory systems
- Provides system troubleshooting and leads in developing end user procedures and work instructions supporting the laboratory systems
- Ensures site users of the system are fully trained and qualified for the respective security roles.
- 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 laboratory operations.
Sample Control and Accountability
- Develop and maintain standard operating procedures (SOP) and training for sample control and accountability
- Compliance to applicable site procedures, EFPs and EGQS
- Proactively identifies risks and develops risk mitigation strategies
- Ensures maintenance of and improvement to the validated state of test methods
- Proactively identifies method improvements and implements improvements via change control.
- Fort Dodge quality control testing is executed in compliance with approved methods, specifications, outline of production, SOPs, Elanco functional procedures and Elanco Quality standards.
- Responsible for execution of training for the department
- Identifies required curricula for Quality Control and performs 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
- Ensures 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
Basic Minimum Qualifications:
- A BS/BA in Biology, Chemistry, Biochemistry, Biopharmaceuticals, or advanced degree is required with a minimum of 10 years in a regulated pharmaceutical /vaccine manufacturing environment.
- 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
- Well versed in all regulatory requirements, inclusive of cGMP/GLP and Elanco requirements.
- 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 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
- 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. Interacts with production, engineering, maintenance, planning.
- Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
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