Associate Director, Medical Affairs Quality Assurance
Associate Director, Medical Affairs Quality Assurance
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Job Description
Purpose
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 peoples 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 products 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 AbbVies 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.
Associate Director Safety Medical & Regulatory Quality is part of the R&D Quality Medical Affairs (MA) QA team which provides independent quality oversight of AbbVies Medical Affairs and Health Impact (MHI) function and other functions engaged in Real-World Evidence (RWE) generating activities. The role covers AbbVies entire portfolio of drug device and cosmetics. The role ensures 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 (AbbVies 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 to deliver business results while positioning AbbVie for future success.
- Develop support and execute a holistic quality assurance model for regulated Medical Affairs and RWE generating activities inclusive of internal and vendor performed activities and ensure integration with interfacing business functions
- Consistently demonstrate AbbVies Ways of Working and Leadership Attributes including a collaborative mindset risk-based thinking and people leadership to support innovation whilst maintaining high levels of compliance.
- 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.
- Lead and contribute to the delivery of innovative quality strategies and solutions through influence and collaboration with MHI and other interfacing functions to support effective and timely solutions/responses to compliance issues/questions including audit/inspection findings.
- Determine and evaluate risks impacting compliance with regulated activities and propose and support the implementation of 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.
- A recognized partner for consultation regarding worldwide 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 R&D Quality business functions to provide support input and consultation to ensure an inclusive and effective R&D 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
This role can be remote within the US.
Qualifications :
- Bachelors degree preferably in Biology Nursing Pharmacy or other science-based degree.
- 5 years of experience in the pharmaceutical industry in the fields of Medical Affairs RWE generation epidemiology 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 R&D Quality business partners and external partners.
- Extensive knowledge of quality standards worldwide regulatory requirements and industry best practices relating to Medical Affairs and RWE generating activities.
- 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 at all levels.
- Comfortable working independently or as part of a team.
- Strong communication and interpersonal skills
Additional Information :
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
Yes
Employment Type :
Full-time
Employment Type
Remote
