Elanco is a global animal health company that develops products and knowledge services to prevent and treat disease in food animals and pets in more than 90 countries. With a 64-year heritage, we rigorously innovate to improve the health of animals and benefit our customers, while fostering an inclusive, cause-driven culture for more than 5,800 employees. At Elanco, we’re driven by our vision of food and companionship enriching life – all to advance the health of animals, people and the planet. Learn more at www.elanco.com
The purpose of this position is to provide administrative and technical direction to Quality Compliance team at the Fort Dodge site. This position ensures that quality products are released to market through proper selection and training of staff, maintaining compliant status within the department and overall facility, ensuring all client commitments and regulatory commitments and adherence to EGQS standards are met. This role oversees training and complaint management systems, is the custodian of the Quality plan, Metrics/KPIs and Elanco Global Quality System gap assessments. This role is also the primary quality liaison for external parties, including clients and regulatory bodies. Manager, Quality Compliance is responsible for identifying and implementing new quality initiatives, systems and strategies to drive continuous improvement and innovation to sustain compliance and competitive advantage. Manager, Quality Compliance shares successful programs with other sites in Elanco network in order to build cross site processes. The role supports execution of quality oversight of biological products through all phases of manufacturing including starting materials, media prep, seed maintenance, fermentation, blending, filling, packaging, labeling, testing and shipping.
Serves as deputy to the Director of Quality in the event of their absence.
Is the primary inspection coordinator for regulatory, third party and internal inspections.
Interprets regulatory and Elanco corporate requirements for compliance
Creates, develops, and implements site programs to align with current regulations, Elanco Global Quality Standards and Elanco Functional Procedures.
Identifies and escalates quality issues per the notification to management system.
Provides quality oversight to the site regarding compliant documentation approaches involving deviations, CAPA and complaints.
Responsible for providing technical guidance, training and oversight for the department and its members.
Owner of site quality plan: identifies compliance risks, develops risk mitigation strategies and ensures commitments are tracked and met per the plan.
Prepares annual expense and capital budgets for QA Compliance and monitors to stay within prescribed limits.
Oversees metrics and KPI reporting requirements in alignment with local Elanco Quality system requirements. Presents at daily huddle meetings and at Site lead team meetings. Submits global metrics per procedural requirements.
Present escalation topics impacting the area of oversight at Elanco Assessment Committee (EAC) meetings
2) Complaints, Deviations and CAPA:
Responsible for overall investigation management system at the site.
Implements Elanco global standard and functional procedure requirements.
Conducts training of employees on complaint and investigation reporting requirements.
Reviews and approves investigations for compliance to procedural requirements.
Ensures cross functional team involvement for determination of appropriate root causes and CAPA.
Drives staff professional development with the compliance and quality teams
3) Regulatory Liaison and Client support
Serve as inspection coordinator for regulatory inspections, third party client audits and Elanco Global Quality Compliance audits
Coordinate with Regulatory Affairs in non routine regulatory communication
Submits escalation topics via Elanco Notification to Management System
Coordinates department leads and subject matter expert input in writing responses to audit and inspection findings.
Provides routine third party client support via adherence to client quality agreements.
Interfaces routinely with external parties and third party quality contacts.
Provides training to the department and site for inspection and audit hosting requirements.
Actively identifies and leads project teams in alignment with site quality strategic direction
Completes own assigned training by target due dates
Ensures training is completed prior to performing work
Identifies professional development opportunities for self and team.
Responsible for execution of training program at the site. Ensures compliance with Elanco quality system requirements for training.
Collaborates with department management in the development and review of employee curricula.
Bachelor’s Degree in Biology, Chemistry, Biochemistry, Biopharmaceuticals, Business Administration, Economics, Engineering or IS/IT. A BS/BA, or advanced degree is required. Ten years of experience or more in a regulated pharmaceutical /vaccine manufacturing environment is preferred.
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
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.
Ability to effectively manage a substantial number of people.
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.
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. Serves as liaison for APHIS Regulatory activities such as inspections, notifications or agency requests.
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