Senior Director, Medical R&D Quality Assurance Drug, Device, and Combination Products
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
AbbVie is dedicated to delivering a consistent stream of innovative, safe, and effective quality medicines and products that solve serious health issues and have a remarkable impact on people’s lives. As a quality organization in research & development, RDQA is committed to driving quality excellence across all stages of discovery and development for the product’s lifecycle to achieve product realization and accelerate access to innovative therapies and products for our patients.
The integration of a new company has ensured a steady stream of therapeutic and aesthetic devices along with the device combination products and drugs, including those from AbbVie. The number, size, scope, and complexity of pharmaceutical investigational products have significantly grown. Devices bring a new set of complexities and require quality governance for specific regulations, separate from pharmaceuticals. For this reason, a new senior-level quality assurance position with physician training and health authority background in quality risk management for pharmaceutical products, devices/combo-device is being added to RDQA. This leader will drive, support, and provide medical consultation to achieve quality excellence especially in quality risk management for the lifecycle of devices/ combo-devices and pharmaceutical products beginning in the research & development space. Although organizations in R&D directly manage the safety and efficacy of the R&D products, there is increasing need to assess quality risk management, an element of the AbbVie Quality System, associated with products under investigation in R&D. The need for medical input within the quality risk management space in R&D has become paramount to allow a more comprehensive approach in R&D for the product/device/device-combo lifecycle that includes quality collaboration.
The Senior Director, Medical RDQA is accountable to ensure quality medical input through strategic, collaborative leadership including but not limited to:
- Developing and upgrading existing device/combo-device policies for AbbVie with a focus on future development under new governing regulations such as EU MDR.
- Enhancement of risk management policies and procedures for drug/device/device-combo in R&D.
- Participation in conducting evaluations in due diligence and post-close assessment of investigational devices/device-combo assets brought into AbbVie pipeline.
- Providing input, consultation and serving as subject matter expert related to device clinical and regulatory requirements worldwide.
- Supporting the creation of and leading/ participating in, high-performing teams focused on device/device-combo in support of building a world-class device organization.
- Instrumental in developing and setting device policy and as requested, combination product and drug policy which includes interacting internally and externally with other functional areas requiring negotiation of complex matters to influence policymaking bodies.
- Conducts evaluations of investigational devices, combination products, drugs, and companies, ensuring compliance with established company and regulatory body procedures, practices, and requirements.
- Builds strong collaborations across R&D and Operations functions, provides medical expert consultation to R&D leadership at all levels in interpreting governmental regulations, agency guidelines, safety and risk management expectations, and internal policies to assure compliance and patient safety in device space. May be required to serve as a liaison between the company and various government agencies.
- Consults on the enhancement of product (pharmaceutical and device, combo-device) risk assessment tools that are forward in design.
- Participates in developing the appropriate risk profile for investigation product in development with fit for purpose thresholds for risk management.
- Actively engages for medical assessment in review and approval of appropriate product complaints and potential safety issues.
- Key medical quality interface with Patient Safety (PPS), Clinical Development, and Global Medical Affairs if appropriate.
- Develops a sustainable process for Health Hazard Assessments, Medical Opinions, with designated safety and clinical teams for potential product issues in development in R&D.
- Participates in cross-industry initiatives with professional societies, regulatory agencies, and other industry-wide collaborations. Represent AbbVie externally to advocate for AbbVie position on evolving and emerging regulations.
- Initiates and conducts, facilitates, or supports special assignments to address emerging or significant needs. Advises, mentors, and trains medical staff and others across organizations to enhance quality of product development, safety, regulatory, clinical investigation, and risk management activities as appropriate.
- Physician (MD or DO) with minimum of 10+ years’ experience with in-depth development knowledge of pharmaceutical products, medical devices, and/or medical devices/combination products.
- Requisite skill working in a complex and matrix environment with multiple stakeholders. Proven success record in supporting products through device/device-combo life cycle management and product approvals.
- FDA or other Regulatory agency experience preferred.
- Expert knowledge of device global regulatory requirements. Demonstrated experience working with regulatory authorities worldwide.
- Demonstrated experience developing and setting device policies, developing, and writing processes and procedures for clinical aspects of regulated products pre-market and preferably post-market as well
- Strategic as well as tactile understanding of pharmaceutical/device quality and GxPs.
- Highly developed leadership skills, including the ability to influence and negotiate, including justification for positions clearly and logically on quality issues and standards.
- Well-developed leadership competencies, including motivation, cultural awareness, active engagement, relationship building, sound judgment, and the management of sensitive proprietary information.
- Excellent communication skills, including superior negotiation and influencing skills. Acute listening skills to gain understanding or to solve a problem and the ability to recognize the difference. Ability to manage difficult conversations and seek alignment.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 10 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.