Associate Director, Global Patient Safety Compliance/Alliance Management
- Remote, Home Office, United States
- Department: Global Patient Safety
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 Associate Director will be empowered to manage all aspects of inspection and audit-related activities within Global Patient Safety (GPS) for assigned audits/inspections, under the guidance and oversight of the VP, Global Patient Safety. Additionally, this role includes primary responsibility for alliance management from the Global Patient Safety perspective including assuring the successful oversight of collaboration agreements and metrics.
- Provide input to current and future alliance structure, governance, operational and business provisions etc,
- Operational best practices to set the stage for an effective and functional working relationship.
- Understand and manage the contractual agreement, strategic intent, obligations, including potential changes in partnership agreements. Identifies issues, conflict resolution, risk mitigation action plans, oversight of the relationship with the alliance partner
- Organise alliance meetings as required either internal or joint meetings with the partner including providing agendas, minutes and distribution of relevant material prior to and post meetings. Facilitate effective functioning of the Alliance Governance structure.
- Monitor and report on the progress of the Alliance against expectations. Analyse root cause, develop and implement action plans to address areas of concern.
- Provide support to pro-actively identify issues and solutions to problems / roadblocks.
- Focus on risk management to identify ‘out of scope’ and ‘out of budget’ situations.
GPS Compliance and Inspection Readiness
- Interfaces and collaborates with various stakeholders including but not limited to the GPS Subject Matter Experts (SMEs), GPS, GPS Vendors, and R&D PV Quality , pre-, during, and post- audits and inspections, to support preparation activities, fulfillment of audits and inspection requests for GPS, and responses to observations.
- Supports compliance-related activities, as needed such as the coordination of Quality Events (QEs), Corrective and Preventive Actions (CAPAs), Effectiveness Checks (ECs), and the monitoring of GPS compliance metrics.
- Maintains current knowledge of relevant PV regulations, including evolving changes in the regulations that may impact compliance.
- Manages special compliance-related projects, as assigned
- Leads audit/inspection activities within GPS for assigned audits/inspections
- Serves as the primary representative within GPS for the preparation and coordination of audits and inspections.
- Coordinates and manages audit and inspection requests within GPS and ensures that appropriate responses and requested documents are provided in a timely manner.
- Coordinates and manages the development and review of responses to GPS audit findings and inspections.
- Collaborates with other inspection management leads outside of GPS and quality/compliance/inspection readiness colleagues for activities related to audits and inspection preparation.
- Evaluates inspection reports from various sources and monitors trends in health authority inspection activities to proactively identify potential gaps and/or areas of risks to be addressed within GPS.
- Supports compliance-related activities, as needed
- Coordination of Quality Events (QEs), Corrective and Preventive Actions (CAPAs), Effectiveness Checks (ECs)
- Monitoring of GPS compliance metrics
- Development of quality and compliance strategies
- Partner closely with members of GPS and the QPPV to support the successful and compliant execution of Aurinia PV activities.
- Review and provide input into the quality sections of the PSMF
- Provide input into the issue management program to ensure early detection of issues, development of appropriate and robust corrective and preventative actions (CAPA), tracking of CAPA completion, and assessment of effectiveness is attained.
- Designs and implements a process for late case investigation.
- Collaborates with GPS, partners, vendors and cross-functional leadership to ensure compliance with all aspects of the PV system.
- Leads training activities, including setting training requirements and training compliance for GPS.
- Elevates a quality mindset across GPS.
- Bachelor of Science degree required; medical or science related field preferred; post-graduate degree or equivalent a plus.
- Strong knowledge of relevant FDA, EU, ICH GCP guidelines, and applicable GVP regulations, guidelines and local legislation.
- Experience working with CROs, vendors, and relationship management.
- Highly motivated with the ability to be flexible in a fast-paced environment
- Experience in Alliance Management, working directly with alliance partners and as part of an alliance team
- Experience with quality management systems, experience with Veeva an asset
- Knowledge of pharmacovigilance regulations and guidelines
- Ability to stay organized, manage both time and priority constraints, and multiple priorities simultaneously, with strong attention to detail in establishing priorities and meeting deadlines.
- Strong execution and drive for results
- Ability to lead teleconferences and meetings.
- Ability to work independently, take initiative while staying within strategic direction set forth by GPS Head.
- Self-starter, pro-active, motivates with diplomacy, a team player with leadership skills
- Good analytical/judgment capabilities to understand/analyze/synthesize and summarize in writing and verbally
- Ability to identify and resolve conflicts with direction from management
- Excellent interpersonal and communication skills, with the ability to interact and collaborate effectively with all levels within the organization
- A strategic thinker. Ability to solve complex problems taking a broad perspective to identify innovative solutions.
- Cultural awareness, experience and agility working across cross-cultural differences
All candidate information will be kept confidential according to EEO guidelines.