Associate Director, Affiliate PV Supplier QA & Training
Establish and oversee an effective quality management system for the CC call types/stakeholder requirements - Product quality, Medical Information, Adverse Event and Commercial. At a minimum this system must ensure compliance with US regulatory requirements and AbbVie standards. The scope extends to collaboration with VMT and spans all marketed products.
Key Responsibilities Include:
Key Responsibilities Include:
- Establish AbbVie quality management processes for external suppliers of affiliate pharmacovigilance services that meet applicable PPS, RDQA, and affiliate standards and ensure reproducible, controlled, and timely delivery of high quality outputs.
- Collaborate with suppliers and internal partners to implement vendor quality management processes which integrate with supplier and AbbVie processes wherever possible, setting clear accountabilities, responsibilities and expectations across all involved parties. Utilize risk-proportionate monitoring paradigms for in-line and retrospective evaluations.
- Maintain a forward-looking quality plan and lead proactive solution development for impactful changes, such as new AbbVie or regulatory requirements, additional service, technology updates, or other identified opportunities or deficiencies. Supports vendor change management.
- Designs, manages and approves training matrices for supplier staff and PPS supplier oversight team members, ensuring each role is properly trained for all job functions.
- Develops materials and delivers training sessions (through multiple modalities) in conjunction with supplier, including train-the-trainer, special-topics, refresher, and internal AbbVie trainings as needed.
- Tracks delivery of training to supplier staff, including certification of new hires/progression in-role. Provides consultation and guidance on supplier training model and materials. Ensures and audits training records for supplier staff.
- Monitors supplier performance via SLAs and other metrics, prepares routine and ad hoc reports, trends incidents, and escalates issues as appropriate. Facilitates integration of supplier performance into relevant stakeholder and management review processes, including PPS and GMA management, AbbVie QPPV, R&D QA, and supplier governance.
- Facilitates internal/third-party audits and health authority inspections of supplier services or AbbVie oversight. Works with supplier to ensure continual inspection readiness including procedural documentation, records, and inspection training.
- Ensure appropriate issue management systems (eg CAPA tracking) are in-place, leveraging and coordinating between established AbbVie and supplier systems. Responsible for communicating and collaborating across stakeholders for proactive identification and prioritization of issues, as well as timely, effective, and permanent remediation efforts.
- Participates in supplier management and governance meetings, and maintains strong working relationship with colleagues in PPS, RDQA, and Affiliate PV & Quality organizations.
- Bachelor's Degree or equivalent in related science field
- 5-7 years pharmaceutical industry experience; including a minimum of 5 years in pharmacovigilance, quality systems and/or training operations. Affiliate experience strongly preferred
- Strong knowledge of global pharmacovigilance requirements, including regulations and affiliate environment, with a firm understanding of related quality assurance systems (including audits/inspections) and adult professional training models
- Experience in health authority inspections and internal/third-party audits
- Skilled at technical writing and authoring, including SOPs/procedural documents, corrective actions plans, audit/health authority responses or submissions
- Influence across multiple stakeholders and manage within an affiliate matrix; seen as a collaborative partner at all levels of the organization
- Proactively identify, rapidly assess, and effectively manage business and compliance risks
- Strong knowledge of relevant outsourcing processes, project management