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Job description
Senior Manager, Safety, Medical & Regulatory Quality
AbbVie is dedicated to delivering a consistent stream of innovative, safe, and effective quality medicines and solutions that solve serious health issues and have a remarkable impact on people's lives. As a quality organization in research & development, R&D Quality Assurance (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.
Patient needs, stakeholder demands, industry innovation, regulatory landscape, and AbbVie's evolved business strategy are complex, rapid pace, and dynamic. Emphasizing and embedding quality in the execution of clinical trials, post market vigilance and post market studies, assures patient safety, maintains data integrity, fosters regulatory compliance, and contributes to the overall success of drug/device development programs.
Senior Manager, Safety, Medical & Regulatory Quality contributes to the management of a RDQA global Safety, Regulatory Affairs (RA) or Medical Affairs (MA) QA team which provides independent quality oversight of safety activities executed by AbbVie's R&D and non-R&D business functions, covering the AbbVie drug, device and cosmetic portfolio. The role contributes to quality excellence through successful business partner collaboration and provides expert technical quality support and consultation to R&D colleagues and business partners. May support Regulatory Agency inspections. The role reports to the Director Safety, Medical & Regulatory Quality. There is an expectation that in performance, leadership, and behaviors (AbbVie's Ways We Work), they serve as a role model to the organization at large.
Responsibilities:
Contribute to a state of continuous compliance with global regulations, AbbVie policies and procedures and regulatory preparedness for relevant Regulatory Authority Inspections and pharmacovigilance and safety inspections and deliver business results while positioning AbbVie for future success
Consistently demonstrate AbbVie's Ways of Working and Leadership Attributes including a collaborative mindset and people leadership manage innovation to reality.
Fulfil expectations and goals to ensure organizational success. Embody a culture of open and honest communication where all are encouraged to express their views, offer suggestions and experiment for improvement.
Support and execute a holistic quality assurance model for applicable GxP activities, inclusive of internal and vendor performed activities and ensure integration with interfacing GxPs and cross functional alignment. Support the delivery of innovative quality strategies and solutions through influence and collaboration with business partners to support effective and timely solutions/responses to compliance issues/questions including audit/inspection findings impacting safety, RA and MA.
Determine and evaluate risks impacting compliance with GxP requirements and proposing suitable mitigations.
Support business process owners directly to ensure quality is integrated at all stages of process development.
Actively participate in front and/or back-room Regulatory Authority inspection activities to enable successful inspections with safety, RA and MA topics in scope.
Is recognized as a partner for consultation regarding worldwide safety, regulations and corporate policies, especially for CAPA and associated Quality disciplines.
Generate, analyze and report metrics to demonstrate key aspects of compliance status, escalating issues in a timely manner for earliest resolution and ensuring the value of QA is recognized and acknowledged
Contribute to the development and implementation of systems and processes required to support implementation of global QA strategies. Contribute with applicable RDQA business functions to provide support, input and consultation to ensure an inclusive and effective RDQA audit program.
Drive necessary change and efficiency through the provision of effective feedback and recommendations; persists in pursuing and achieving organizational goals and objectives.
Create an impact by modeling the AbbVie Behaviors in a consistent and visible manner in the conduct of all responsibilities.
Qualifications:
Bachelor's degree preferably in Biology, Nursing, Pharmacy, or other science-based degree.
5 years of experience in the pharmaceutical industry in the fields of pharmacovigilance, regulatory affairs and/or quality assurance supporting those areas.
5 years of experience in Quality Assurance.
Strong analytical skills and the ability to organize work in a logical, thorough, and succinct manner. Ability to work and interact with RDQA business partners and external partners.
Extensive knowledge of quality standards, worldwide regulatory requirements and industry best practices relating to safety, RA or MA.
Flexibility to adapt to changing assignments and ability to effectively prioritize with minimal supervision. Ability to work in a fast-paced, high pressure and changing environment in an autonomous manner.
Project management, interpersonal, and communication skills with ability to influence.
Comfortable working independently or as part of a team.
Strong communication and interpersonal skills.
Where We Work:
Role is primarily site- or office-based but can occasionally be performed remotely. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.
Worksite address
waltham, MA, 02254, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.