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
This position is the Regional Quality Leader (RQL) for R&D the Americas, and is accountable for the oversight, direction and management of R&D Quality site operations and projects within the Americas. This role provides business partnership to R&D leaders to ensure that appropriate systems, procedures and resources are in place for effective execution of the R&D quality system. In addition the role assures that all aspects of the regulated activities in the region comply with Health Authority requirements and are appropriately handled
Functions, Duties, Task:
Responsible for the execution of the global Quality Assurance and Compliance Strategy for R&D Organization through appropriate application of GxP & other relevant external standards & regulations including Elanco Quality standards within the Americas Region.
Lead quality oversight activities of all functions within the regional R&D organization together in partnership with R&D leadership.
Provide, or ensure the provision, of expert opinion for GCP, GLP or GMP issues and ensure quality compliance.
Drive quality culture initiatives across the R&D America’s team to prevent significant quality issues or regulatory non-compliance which could lead to product approval delays or other actions which would negatively impact the customer, the financial performance and/or reputation of the company.
Ensures that adequate Quality resources are available to support business needs, including, but not limited to, Clinical (GCP), Safety (GLP), Research (GRP), Pharmaceutical Science & Technology (GMP), and Stage Gate reviews.
Provides leadership for QA staff supporting R&D operational units located in the Americas. Responsible for goal setting, performance management, compensational decisions, and other supervisory duties for the team reporting to the position.
Responsible for ensuring monthly/quarterly metrics are compiled and presented to management.
Provide quality oversight of regulatory submission documentation for technical development, safety, and efficacy operations in R&D.
Assure audit readiness of auditable units within R&D Areas of responsibility.
Ensure appropriate information flow and effective communication of all relevant quality matters within the Global R&D organization/the Global Quality organization including issue escalation as appropriate.
Lead quality oversight of third parties such as contract research organizations, contract research laboratories etc. and ensure that they are qualified to perform their activities in compliance with internal & external frameworks.
Develop quality talent to sustain local and global competitiveness. This includes development of individuals with leadership potential, providing mentoring and enrichment opportunities consistent with succession planning.
Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety and environment (HSE) policies. Perform any other duties or serve in such other capacity as may be determined by Company management
Bachelor’s Degree (minimum) in Pharmacy, Science, Engineering, or related field
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
Demonstrated pharmaceutical drug or vaccine development experience, within an animal health or human health environment.
Demonstrated technical leadership across areas including, but not limited to, technical development, product manufacturing, biologics manufacturing, microbiology, efficacy and safety, pharmacovigilance and/or regulatory submissions.
Demonstrated knowledge in GLP and/or GCP and GMP compliance in one or more global regulatory environments (FDA, USDA, and EMEA).
Demonstrated leadership experience within in matrix environment, including experience leading multi-cultural teams and influencing senior technical and business leaders
Effective interpersonal and communication skills, must understand how to influence and diplomatically challenge when needed.
Demonstrated ability to initiate and drive change across sites; projects & the wider organization.
Proven track record with inspection management: FDA, USDA, and others
Strong understanding of risk assessment and risk management fundamentals/tools
Desired, Masters or PhD in Life Sciences or Management
Expected Travel : Up to 25%
Member of the AH/EEM, R&D Q Lead Team, of ERDQA Leadership team and other governance bodies as required.
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