Director Quality , Augusta
Company Overview ?? ?Elanco is a global research-based company that develops and delivers product and services to enhance animal health and production. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 6,500 employees in more than 70 countries. Founded in 1954, Elanco is a division of Eli Lilly and Company.Responsibilities ??? Lead the Quality Assurance and Quality Control teams at the Augusta site. Assure appropriate Q oversight of site manufacture, testing, and distribution, including the assessment and mitigation of risk to quality practices and supply, and ensuring all aspects of the quality and the management thereof, are in compliance with cGMP and regulatory requirements, applicable Elanco/Lilly Quality Policies, and industry practices.Ensures all aspects of Quality Management at Augusta is carried out according to the GMP standards defined, and is regularly reported and assessed for adequacy of performance including Batch Release, Quality Control, Training, Self-Inspection, Deviation and OOS investigations, Customer Complaints, PQR, Document Management and Stability Oversight activities.Manage/support the resolution of quality and technical problems in alignment with global standards.Ensure that the all critical and major issues which may have an adverse effect on the quality of the product are escalated as per standard procedures to management and are resolved within stated timelines.Serve as a member to the Site Leadership Team (SLT), and actively participate in site strategic planning.Support Development of the Quality Strategy and the Quality Planning for the site. Assure that all critical issues are incorporated with clear and timely actions within the Site Quality Plan.Drive Internal Site readiness for HA inspections (PAI, directed, other).Assure that there is appropriate interaction between the Site and the regulatory authorities where required.Ensure that GMP follow up actions for audit/inspection observations are available. Ensures implementation, maintenance and review of same.Establish and monitor Key Performance Indicators and ensure that all parts of the site organization are working in a consistent manner against harmonized expectations. Together with the SLT, initiate corrective actions when necessary and perform follow-up on resulting measures.Assure the appropriate resourcing, at the site to support the quality assurance and QC testing processes.? Provides oversight and resourcing where applicable for projects (site upgrade projects, launches, other).Conduct management reviews of process performance and product quality and of the quality system.Support deployment of operational excellence strategies within Augusta.Assure accurate, reliable, efficient and timely QC testing of raw materials and finished products.Together with the Site Leadership Team develop a continuous improvement RFT quality cultureMange and develop the Quality Operations Budget on an annual basis. Assure that adequate facilities and resources are available to the QA/QC teams to assure compliance and meet Plant Business Objectives.Monitors internal site KPI laboratory performance to assure delivery in alignment with business requirements ? RFT rate, Cycle Time and Budget performance.Work closely with the SLT to assure business and quality objectives are achieved at the site and that a business partnership culture is maintained with Q and other cross functional partners.Recruit and develop talent to sustain local and global competitiveness. This includes identifying individuals with leadership potential, providing mentoring and enrichment opportunities consistent with succession planning.Ensures deployment of the EQS at the Augusta and contribute to the development of these standardsDeploys Quality Risk Management Techniques for quality oversight and problem resolution at Augusta when required.? Mitigate unacceptable risk in conjunction with the SLT and Elanco EMPC/Quality Management.Ensures the Quality Assurance Agreements for Suppliers are created and maintained according to Elanco requirements, that they are regularly reviewed and followed, and that they address the respective roles, responsibilities and requirements for all parties involved in the supply of the product.?Basic Qualifications ?? ?Minimum Bachelor?s degree in chemistry, microbiology, pharmacy, or physical or biological sciences, engineering or other technical areas of study.5 years experience in QA,10 years of management and or project management experience.??5 years experience in the pharmaceutical industry, with direct experience with Pharmaceutical/API products.5 years experience in QA Operations, Manufacturing, QC and/or other relevant operational areasAdditional Skills/Preferences ?? ?Desired, Masters or PhD in Life Sciences or ManagementKnowledge of Continuous Improvement Six SigmaThorough knowledge of global cGMP requirements.Strong understanding of regulatory requirements for commercial global DP/API processes, with knowledge of parenteral/sterile operations.Proven track record with inspection management FDA, EMEA, and othersStrong understanding of risk assessment and risk management fundamentals/toolsTechnical understanding of DP/API manufacturing/testing processesStrong ability to effect change management of people, process and procedures.Fluent in speaking / writing EnglishProblem solving skills and the ability to deal with ambiguity?Additional Information ?? ?Position supports a 24/7 operation so some night and weekend support will be requiredSome travel may be requiredRequired to carry a cell phoneLilly 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.?Removal Date ?? ?14-Jun-2017?Apply for this job.