Describe the primary goals, objectives or functions or outputs of this position.
The foundational requirements for our products are that they meet the highest standards of quality, safety and efficacy. The role of Quality Assurance is to ensure that our products are consistently produced, controlled and supplied to these highest quality standards, to meet our patients’ needs. Product Safety and Efficacy are inherently linked with product Quality and it is paramount that key quality decisions with potential impact on patient safety are underpinned by solid medical expertise.
As Abbvie continues to expand its global footprint and launch new products, the quality assurance function needs to continuously evolve. The Director of Medical Quality Assurance is the leader and key medical advisor within QA supporting AbbVie’s current products and pipeline portfolio.
The Director of Medical Quality Assurance is responsible for ensuring that the Quality System is robust and incorporates medical input at key stages of the product lifecycle.
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
- Design of product life cycle strategy, where key Quality System areas are underpinned by medical knowledge commensurate with the potential risk to patient safety e.g. risk assessment, manufacturing / distribution events, product complaints & product discontinuation
- Support the development and maintenance of device / combination products (e.g.- Design History Files, Risk Management Files, product benefit-risk assessments)
- Support the design of ‘product-use’ risk assessment tools, ensuring that the product risk/benefit profile for HCP/patient usage is appropriate
- Review of significant product changes, including specification changes, ensuring appropriate assessment of the proposed changes on patient safety
- Support the design of robust ‘alert’ and ‘action’ thresholds for product complaints, to enable effective signal monitoring, detection and action
- Review and approval of appropriate product complaints providing medical assessment of the potential risk to patient safety
- Review and approval of appropriate product labelling issues providing medical assessment of the potential risk to patient safety
- Review and approval of appropriate manufacturing / distribution events providing medical assessment of the potential risk to patient safety (Member of Triage Committee)
- Approval of Health Hazard Assessments & Medical Opinions, with Product Safety Team partnership, to support potential product related issues
- Support ‘in-field’ activities to better understand product performance with HCPs
- Key medical quality interface with Pharmacovigilance & Patient Safety (PPS), Global Medical Affairs (GMA) and Clinical Development on high impact quality issues potentially affecting product safety & efficacy, including supporting construction of DHCP communications
- Key medical quality interface with AREA and Affiliate Medical Directors on product issues requiring assessment and potential reporting to regulatory agencies e.g. quality defects & drug shortages
- Ability to effectively write, review and provide input on technical/regulatory documents
- Lead and implement risk management strategy for assigned products
- Support inspection readiness and inspections by regulatory agencies.
- MD/DO with 2+ years of residency with patient management experience and Master Public Health is preferred in addition to MD/DO but not required
- 2-4 years of Pharmacovigilance experience in the pharmaceutical industry
- 2-4 years of Quality, Regulatory Compliance experience in pharmaceutical industry, preferred
- Strong understanding of quality and GxP
- Experience in managing complex quality events in a strongly regulated environment
- Sound decisions-making and analytical skills contributing to high levels of competence, confidence and credibility
- Role can be based Remotely in the US
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced