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.
As a member of the globally integrated Elanco R&D Quality Assurance (ERDQA) Leadership Team, this position (Director Quality R&D – Americas Region) is accountable for the oversight, direction, and management of the Quality R&D Americas Region organization to ensure the regulated activities for Elanco R&D and Innovation Regulatory are consistently and appropriately handled within Americas Region. This role provides compliance oversight and business partnership to R&D and Regulatory leadership to ensure that appropriate quality systems, procedures and resources are in place for effective execution of the R&D quality management system.
Functions, Duties, Task:
The Director Quality R&D – Americas Region accountabilities include, but are not limited to:
- Responsible for the implementation of the global Quality Assurance and Compliance Strategy for Quality R&D and Innovation Regulatory including but not limited to external regulations, Elanco Global Quality Standards, and procedures.
- Responsible for ensuring Quality oversight of R&D and Innovation Regulatory for Americas Region organization together with qualified staff, efficient processes, governance and in partnership with R&D and Regulatory leaders and staff. Additionally, provision of guidance, support, and resources for globally integrated Quality R&D team.
- Ensures that trained and qualified Quality resources are available to support the business needs, including, but not limited to, Clinical Efficacy (GCP), Safety (GLP), CMC (GMP) and associated Regulatory Authority Inspections.
- Ensure robust development plans for ERDQA Americas Region talent to sustain local and global compliance and current state of industry and health authority positioning. This includes identifying individuals with leadership potential, providing mentoring and enrichment opportunities consistent with succession planning.
- Provide leadership to ensuring clear definition, execution and understanding of roles and responsibilities.
- Head of Quality Assurance Unit for Fort Dodge R&D FDA GLP Test Facility.
- Provide quality review of R&D Quality Management System (e.g., standards and procedures) and regulatory submission documentation.
- In partnership with R&D Leadership, drive quality culture within ERDQA Americas Region and global R&D and Innovation Regulatory.
- Identify and drive continuous quality process improvements as a consequence of audits, assessments, inspections, trends, metrics, and root cause analysis
- Drive implementation of Quality by Design principles
- Actively participate and make meaningful contributions
- Deliver independent expert support and propose solutions
- Provide input to the EGQCA audit plan based on utilization, identified signals/trends/risks
- Support successful Health Authority engagement
- Ensure efficient information flow and effective communication of all relevant quality matters within and across the Global Quality R&D and relevant R&D business partners, including but not limited to issue escalation.
- Comply with all company local and global policies and procedures including Quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety, and environment policies.
- Perform any other duties or serve in such other capacity as may be determined by Company management.
Minimum Qualification (education, experience and/or training, required certifications):
- Master’s Degree in Biology, Chemistry, Pharmacy, Science, Engineering, or related field.
- Certification from quality association (e.g., SQA RQAP-GLP, ASQ) a plus.
- Minimum 5+ years experience in Quality Assurance
- Demonstrated pharmaceutical drug and vaccine development experience, within an animal health and/or human health environment.
- Demonstrated ability to lead and develop teams
- Demonstrated expertise in GLP and GCP regulations in one or more global regulatory environments (e.g., EMA, EPA, FDA, USDA). GMP knowledge a plus.
- Demonstrated leadership experience operating within in matrix environment, including experience leading multi-cultural teams and influencing senior business partners and key stakeholders.
- Effective interpersonal and communication skills; must understand how to influence and diplomatically challenge when needed.
- Demonstrated ability to initiate and drive change within and across business functions, projects & the wider organization.
- Proven track record with inspection management (e.g., FDA, EPA, USDA).
- Strong understanding of risk assessment and risk management fundamentals/tools
- Expected Travel: Up to 15%
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