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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.
Responsible for the oversight, direction and management of the Affiliate Quality Team and all Affiliate Quality activities within Canada. Collaborate with Affiliate leaders to ensure that appropriate systems, procedures and resources are in place for effective execution of the Affiliate Quality System. Ensure that all aspects of the regulated activities in Canada are consistently and appropriately handled.
Functions, Duties, Task:
Implement & maintain the Canadian Affiliate quality system - consisting of competent staff, appropriate standards, efficient processes, and effective governance and in partnership with the Affiliate / Regional leaders.
Drive quality culture initiatives across the Canadian affiliate to prevent significant quality issues or regulatory non-compliance, which could lead to product stock-out or withdrawal, product approval delays or other actions, which would negatively impact the customer, the financial performance and/or reputation of the company.
Ensure efficient information flow and effective communication of all relevant quality matters within and across the Canadian affiliate organizations, from the country to the Global QA organization and vice-versa.
Act as the Quality representation on behalf of Elanco Canada with Canadian Regulatory Authorities.
Partner with the Regulatory organization to ensure that coordinated contact is maintained with the local Regulatory Authorities and roles and responsibilities between the two functions are clearly defined and executed.
Implement an effective complaint reporting system to ensure the affiliate meets applicable regulatory requirements, including quality oversight of call centers. Collaborate closely with Pharmacovigilance organization to ensure appropriate coordination/alignment with AE investigation and reporting.
Escalate quality and/or regulatory issues through the Notification to Management process, ensure adequate assessment of issues are completed locally and CAPA are addressed.
Coordinate and host both internal (EGQCA) and external Regulatory audits.
Ensure that all marketed products are dispositioned in accordance with local/international regulations and ensure that change management processes are adhered to for new product launches.
Ensure quality oversight processes are in place for collaborations such as warehouses, distributors, secondary packaging operations etc. and ensure that they are qualified to perform their activities in compliance with local requirements.
Ensure quality oversight processes are in place as dictated per Quality Agreements with distribution agreements for products where Elanco does not hold the registration.
Provide quality requirements for regional/local business development agreements.
Ensure Quality Systems are in place at the Canadian Affiliate, which cover GxP training, self-inspections, product returns, recalls (including mock recalls), APQR approvals, stability review, Quality Manual and oversight of supplier/service provider management.
Implement quality management review and governance processes to ensure the efficient and compliant operation of Canadian Affiliate quality systems
Provide leadership for Quality employees in the Canadian Affiliates, ensuring clear definition, execution and understanding of roles and responsibilities, supervision and coaching.
Collaborate with regional quality network to identify and implement global processes and report local quality metrics.
Develop talent to sustain Elanco’s competitiveness. This includes identifying 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 Quality management.
Minimum Qualification (education, experience and/or training, required certifications):
Minimum Bachelor’s degree in chemistry, microbiology, pharmacy, or physical or biological sciences, engineering or other technical areas of study.
Experience / competences:
Demonstrated experience in the pharmaceutical industry, with direct experience with Pharmaceutical products. Experience in QA Affiliate Operations, Manufacturing, QC and/or other relevant operational areas, but must include Quality leadership and / or project management experience.
Thorough knowledge of cGMP / cGDP requirements.
Demonstrated understanding of regulatory requirements for commercial products
Proven track record with inspection management; both internal & external
Strong understanding of risk assessment and risk management fundamentals/tools
Technical understanding of manufacturing/testing & product release processes
Fluent in speaking / writing English
Problem solving skills and the ability to deal with ambiguity
Demonstrated effective business partnering
Resilience / adaptability to a dynamic environment with constant changes
Positive attitude / enthusiastic
Interpersonal savvy / builds network
Optimize work process
Quality decision maker
Promote team building
Knowledge of Continuous Improvement Six Sigma and Lean Principles
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