Location: Remote #LI-Remote
About this role:
The Senior Development Quality Assurance Associate Director is responsible for leading complex investigation, major health authority inspections and novel projects (e.g. developing quality risk management strategies in novel situations) for assuring the quality and compliance of Global Drug Development (GDD), Global and local Medical Affairs (MA) & Commercial patient-facing projects, products and programs.
Forward-thinking candidates are invited to apply to facilitate and support our Global and Local business partners to assure the Development portfolio is delivered with excellent quality.
Key Responsibilities:
•Drive Clinical/Pharmacovigilance QA investigation activities for Quality Issue/Incident Management at the country level as appropriate and ensure implementation of robust Corrective Action and Preventative Action (CAPA) plans where applicable. Take accountability for escalation of GCP/GPvP process non-compliance as needed.
•Support a culture of proactive, risk-based behavior. Monitor local Quality System, processes and Key Quality Indicators (KQIs) to proactively identify potential quality risk. Collaborate with business partners to ensure that risks are reviewed for root cause, impact, and recurrence and assure that relevant line function owners put in place mitigation plans to address any compliance gaps and implement strategic process improvement, including review of procedural updates, training and effectiveness checks, etc.
•Provide leadership and/or support for Inspection Management as needed for GCP and GPvP HA inspections of activities. Assure support prior to (e.g., inspection readiness activities, including participation in regulatory inspection preparation, etc.), during and post inspection for the country organization, investigational sites and/or external service providers, as applicable, in collaboration with the assigned inspection lead.
•Partner with local and global Development teams and other internal stakeholders in audit execution, and follow-up of Audits on clinical development and PV activities (including external service providers who support these activities). Collaborate with the business, and auditees as appropriate to determine root cause for identified audit and verify robust and sustainable corrective and preventive actions (CAPAs) are implemented. Act as local approver for the documentation and management of local CAPAs to support appropriate review and closure of each corrective and preventive action.
•Lead/co-lead local quality operations meetings and ensure any identified trends/risks related to PV or GCP are communicated and addressed in a timely manner. Ensure a process is in place to update local functions on the possible impact of changes to local and/or global requirements and regulations. Ensure there is an appropriate interface with internal/external stakeholders for any GCP/PV related activity (e.g., local Health Authority, clinical and PV related changes/initiatives). Partner with local country quality team to ensure the analysis, assessment and resolution of issues with common interfaces (including CAPAs).
This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 10% travel.
Minimum requirements
Essential Requirements:
•Education: Bachelors’ Degree, preferably in Life Sciences, chemistry or related relevant degree
•At least 7 years’ experience in the pharmaceutical industry in a relevant field such as quality assurance, regulatory affairs, pharmacovigilance or a directly related area, preferably with a minimum of 3 years’ experience in clinical development.
•Experience in leading projects
The pay range for this position at commencement of employment is expected to be between $144,000 and $216,000 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook: https://www.novartis.com/careers/benefits-rewards
Accessibility and Reasonable Accommodations:
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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