Vice President, Quality
- Remote, Home Office, Home Office, United States
- Employees can work remotely
- Department: Quality
Aurinia exists to make a difference in transforming people’s lives by delivering innovative treatments to patients living with serious, rare autoimmune and inflammatory diseases. From the earliest days of the company, we’ve applied an inventive, thoughtful, and responsible approach to developing therapies for people in need. Through our dedication, we relentlessly preserve and execute with integrity to reach our main objective, to improve patients’ health.
In addition to driving adoption of our approved therapy, LUPKYNIS™, for appropriate people with lupus nephritis, we are also actively pursuing a broader portfolio of innovative drugs for autoimmune disease.
Our strategy leverages the skills and knowledge of our incredible team and our deep experience in principled drug development and commercialization. Aurinia provides a working environment where individuals can thrive in a professional, creative, and inspirational atmosphere. Together, we are driven to make an impact for our patient communities as advocates and partners in innovation.
The Vice President, Quality oversees the global quality function at Aurinia. The objectives of the position are to develop a GxP compliant Quality strategy in alignment with company objectives, implement Quality standards and improve efficiency. A leader with vision and strategic influence, this position leads a dispersed Quality team.
Responsible for developing, implementing and oversight of the Quality Management System that is suitable for clinical and commercial operations. The VP, Quality will develop and sustain successful close collaboration with all other departments within Aurinia and externally with all GxP vendors, external experts, collaborators, and strategic partners. Integral for this role is to maintain a high-level understanding of global quality requirements and anticipate the impact of the changing environment.
- Sets the vision and direction for Quality at Aurinia, developing a strategic plan to ensure successful implementation of objectives of the Quality team.
- Oversees the quality function within Aurinia to deliver all projects within time and budget with a goal to lead continuous improvement and ensure the effectiveness of quality systems
- Responsible for the inspection readiness program
- Accountable for all quality activities for development and commercial projects.
- Oversees the planning, preparation and technical review of quality documentation.
- Supports the development and production of Aurinia drug products through implementation of phase appropriate quality systems.
- Ensures that quality guidance is provided to global development teams.
- Provides leadership that ensures successful inspection outcomes for all Aurinia products, both internally and with external partners.
- Reviews regulatory submission documents in connection with health authority interactions, be they written responses or face to face meetings
- Ensures quality staff work closely with cross-functional team members and external providers to ensure timely and effective support of product progression
- Maintains a high-level understanding of global (ICH, FDA, EMA) quality requirements including those applicable to both investigational and commercial products.
- Provides quality support for due diligence activities associated with the assessment of business opportunities as necessary.
- Builds and maintains capacity within the quality team and actively supports the development of individuals within the teams.
- Develops the technical and leadership skills of direct reports, actively supporting career progression.
- BS/BA Chemistry or Biology or Pharmaceutical Science, advanced degree preferred
- 25 years’ pharmaceutical drug development experience including GMP, GCP, GLP, GVP, GDP, and CSV .
- 10 or more years in a senior management role with increasing levels of responsibility
- Relevant industry accreditations will be considered an asset
- Comprehensive working knowledge of US and international quality (development and commercialization of pharmaceuticals) requirements/processes and the ability to apply knowledge both strategically and operationally to development projects and commercial product issues
- Experience preparing for and hosting regulatory inspections
- Strong hands-on experience in development of Quality Management Systems
- Knowledge of quality systems including, change control, vendor qualification, investigations, deviations/CAPA, complaint handling, and recalls
- Experience supporting and conducting due diligence activities
- Proven ability to consistently achieve results, even under tough circumstances
- Actively learns through experimentation when tackling new situations and learns from both success and failures.
- Excellent skills in planning, organizing, decision-making, attention to detail and problem-solving
- Excellent communication (verbal, writing and presentation) skills and the ability to work collaboratively
- Ability to gain the confidence and trust of the Quality team through honesty, integrity and authenticity
- Ability to effectively delegate tasks and hold others and oneself accountable
- Proficiency in MS Office, Sharepoint and Teams
- Ability to consistently exhibit Aurinia’s We Care values of creating opportunity, acting responsibly, relentlessly persevering and executing with integrity
All candidate information will be kept confidential according to EEO guidelines