Senior Director of Risk Management
2 weeks ago
If you find science, speed, and success exhilarating, you have come to the right place.
Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world’s most pressing infectious diseases. We have more than a decade of experience contending with some of the world’s most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.
Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic. We are seeking a Director, Clinical Quality Assurance to join our Clinical Quality Assurance department and provide leadership in collaboration with required functional areas to ensure compliance with applicable Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP) and Good Clinical Laboratory Practices (GCLP) regulations, and any other applicable regulatory requirements. The incumbent is expected to build and maintain cross-functional relationships with key functional areas including but not limited to: Clinical Operations, Pharmacovigilance, and Regulatory Affairs.
Serve as support for strategic and operational management, contributing to direction, oversight, and management of all clinical quality assurance activities.
Contribute to the design, analysis, and oversight of global, phase-appropriate clinical Quality Management System (QMS) policies and procedures to ensure compliance to applicable regulations, including U.Support the management of quality oversight of GCP, GVP and GCLP activities (including SOP/policy development and maintenance, vendor management, internal and external audit functions, and clinical batch release program) to ensure patient safety and data integrity.
Provide consultation and mentorship across the organization to ensure quality assurance strategies are implemented.
Keep senior leadership apprised of changes to the clinical quality compliance landscape affecting business performance.
Support the development and administration of budgets, plans, and performance requirements linked to the clinical quality assurance department.
Serve as a QA contact for oversight of Clinical Studies in US, EU, and ROW regions to ensure compliance with all applicable GCP, GLP, GCLP/ regulatory regional requirements.
Liaise with partners in Clinical, Medical Affairs, Regulatory Affairs, Pharmacovigilance, and Information Technology as needed to support clinical studies.
Support the establishment/assurance/remediation as needed for current quality processes, systems and procedures associated with clinical studies.
Collaborate with cross-functional management to drive clinical process improvements and alignments.
Serve as a contact for all regulatory or third-party inspections related to Novavax sponsored clinical and pharmacovigilance activities. This includes on site at Novavax and remote sites.
Maintain in depth understanding of business principles, industry dynamics, regulatory environment, market trends, and specific operational details related to GCP, GLP, GCLP and GVP QA activities.
Experience with Quality Management Systems implementation and management
Experience with senior level interactions and influence with Clinical, Regulatory, Pharmacovigilance and Medical Affairs functions.
Knowledge of global regulatory expectations (including FDA and EMA).
Strong understanding of GCP, GLP, GCLP for pre-clinical and clinical stage work, and PV Quality for marketed product.
Direct experience in successfully managing Health Authority Inspections and multiple projects and responsibilities concurrently.
Experienced and fully capable to implement and ensure quality in a GxP-regulated environment (eg, GCP oversight, auditing, electronic systems management, laboratory management, PAI inspection readiness)
Team player willing to roll up sleeves ad hoc to get the right result; Ability to make rationale, scientific, timely, and compliant risk-based decisions.
Bachelor’s degree in a scientific discipline
~8+ years of experience in pharmaceutical, biologics and/or vaccine life sciences in GCP/GCLP/GVP/GLP functions and/or QA.
Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.
Except where prohibited by applicable state law, this position requires that you be fully vaccinated against COVID-19 unless you need a reasonable accommodation or qualify for an exemption. Think future-forward and help solve some of the world's most pressing global health challenges. If you find science, speed, and success exhilarating, you have come to the right place.
Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world’s most pressing infectious diseases. We have more than a decade of experience contending with some of the world’s most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.
Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic. #
-
Senior Consultant/Director
2 weeks ago
United Kingdom Trascent Management Consulting Full timeTrascent, a leading global management consulting firm, focuses on delivering quantifiable, lasting performance improvements in all facets of corporate real estate, including facilities management, real estate, corporate and project services, to global Fortune 500 corporations. POSITION SUMMARY We are seeking a Senior Consultant/Director to support our...
-
Associate Director, Network Risk Management
1 week ago
United Kingdom RSM UK Full timeAssociate Director - Technology Risk Assurance We are searching for an experienced Associate Director - Technology Risk Assurance Are you passionate about emerging technology, cyber, change, and risk management in the financial services sector? Our world is ever more complex, interconnected, and reliant on technology and data to do business. While the...
-
Senior Sales Director
2 weeks ago
United Kingdom Talentee Full timeSenior Sales Executive | Third-Party Risk Management As a Senior Sales Executive, you will play a key role in managing inbound leads generated by our BDRs. With a dedicated Pre-sales person at your side, you will focus on discovery and engagement with potential clients. Your primary responsibility will be to understand the specific risk management needs of...
-
Senior Sales Director
Found in: Jooble UK C2 - 2 weeks ago
United Kingdom Talentee Full timeSenior Sales Executive | Third-Party Risk Management As a Senior Sales Executive, you will play a key role in managing inbound leads generated by our BDRs. With a dedicated Pre-sales person at your side, you will focus on discovery and engagement with potential clients. Your primary responsibility will be to understand the specific risk management needs of...
-
Risk Management
7 days ago
United Kingdom Association for Project Management Full timeProject Director - NEC 4 Highways Scheme We are seeking a highly skilled and experienced Project Director to lead a major NEC 4 Highways Scheme. The successful candidate will play a pivotal role in controlling early contractor involvement and managing work streams to ensure the successful delivery of the project. Strategic Planning : Develop...
-
Director Risk and Policy Legal
Found in: Jooble UK C2 - 6 days ago
United Kingdom Reward Gateway Full timeEdenred is a leading digital platform for services and payments for people at work, connecting 52 million users and 2 million partner merchants in 45 countries via close to 1 million corporate clients. With our shared missions of ‘Making the World a Better Place to Work” and ‘Enriching connections, For good’ , you’ll be contributing to improving...
-
Director Risk and Policy Legal
6 days ago
United Kingdom Reward Gateway Full timeEdenred is a leading digital platform for services and payments for people at work, connecting 52 million users and 2 million partner merchants in 45 countries via close to 1 million corporate clients. With our shared missions of ‘Making the World a Better Place to Work” and ‘Enriching connections, For good’ , you’ll be contributing to improving...
-
Medical Director for Community Health Services
2 weeks ago
United Kingdom Highgate Senior Living Full timecommunity, not a facility. we take a positive, holistic approach to senior care and encourage opportunity will allow you to positively impact the quality of life for over 700 seniors and their families. REGISTERED NURSE/HEALTHCARE DIRECTOR are looking for the right person to partner with our team to oversee and help implement the day-to-day nursing...
-
Director - Risk Management & Transformation
1 week ago
United Kingdom Bestman Solutions Full timeTransformation Director - Salesforce Implementation, 9-12 Months contract We are working with a leading global data company dedicated to innovation and excellence. They are embarking on an exciting CRM transformation journey and seek a talented and experienced Transformation Manager to lead their Salesforce implementation. As a key player in the...
-
Director - Risk Management & Transformation
Found in: Jooble UK C2 - 1 week ago
United Kingdom Bestman Solutions Full timeTransformation Director - Salesforce Implementation, 9-12 Months contract We are working with a leading global data company dedicated to innovation and excellence. They are embarking on an exciting CRM transformation journey and seek a talented and experienced Transformation Manager to lead their Salesforce implementation. As a key player in the...
-
Risk Management
5 days ago
United Kingdom Association for Project Management Full timeDV Cleared Project Manager Our client require an experienced DV Cleared Project Manager / Senior Project Manager (Inside IR35 & Hybrid Working) to lead the delivery of an IT project and support a growing portfolio of work. You will oversee and drive delivery of a multi-skilled team delivering to Agile methods, ensuring key milestones are achieved. You...
-
Healthcare Director
2 weeks ago
United Kingdom Highgate Senior Living Full timeLOVE YOUR WORK. JOIN OUR TEAM. A community, not a facility. As thought leaders in the industry, we take a positive, holistic approach to senior care and encourage independence, as people are happiest when they can make their own choices. We provide opportunities for physical activity, social engagement, intellectual stimulation, spiritual involvement,...
-
Director, Technology Risk Management
2 weeks ago
United Kingdom 73.Today Ltd Full timeMarket Supply Distribution Quality Process Director Including global business process owners (GBPO) for complaints, PIRC, GDP and warehousing, and provide the strategic direction and operational priorities across the Quality teams. Accountable for implementation of QMS within MDSQ to ensure that teams and activities are aligned to deliver functional and...
-
Risk Manager
5 days ago
United Kingdom Croftstone Full timeWe are a leading multi-disciplinary management consultancy providing end-to-end support for large-scale infrastructure programmes. We are proud to have over 250 years' combined experience in Rail infrastructure and Construction. As an organisation, we believe that a workplace should be more than just a place to clock in and out – it should be an...
-
In House Counsel
2 weeks ago
United Kingdom The Legal Director Full timeWe are looking for UK-based senior business lawyers who are qualified in England & Wales with significant in-house experience and at least 10 years PQE. Selling legal services in a way that no-one else does, The Legal Director provides businesses with high-calibre, experienced lawyers on a part-time and/or flexible basis. The Legal Director is ideal if...
-
In House Counsel
Found in: Jooble UK C2 - 2 weeks ago
United Kingdom The Legal Director Full timeWe are looking for UK-based senior business lawyers who are qualified in England & Wales with significant in-house experience and at least 10 years PQE. Selling legal services in a way that no-one else does, The Legal Director provides businesses with high-calibre, experienced lawyers on a part-time and/or flexible basis. The Legal Director is ideal if...
-
In House Counsel
Found in: Appcast UK C2 - 7 days ago
United Kingdom The Legal Director Full timeWe are looking for UK-based senior business lawyers who are qualified in England & Wales with significant in-house experience and at least 10 years PQE.Selling legal services in a way that no-one else does, The Legal Director provides businesses with high-calibre, experienced lawyers on a part-time and/or flexible basis. The Legal Director is ideal if you...
-
In House Counsel
Found in: Whatjobs ES C2 - 3 days ago
United Kingdom The Legal Director Full timeWe are looking for UK-based senior business lawyers who are qualified in England & Wales with significant in-house experience and at least 10 years PQE. Selling legal services in a way that no-one else does, The Legal Director provides businesses with high-calibre, experienced lawyers on a part-time and/or flexible basis. The Legal Director is ideal if you...
-
In House Counsel
Found in: Appcast UK C C2 - 7 days ago
United Kingdom The Legal Director Full timeWe are looking for UK-based senior business lawyers who are qualified in England & Wales with significant in-house experience and at least 10 years PQE.Selling legal services in a way that no-one else does, The Legal Director provides businesses with high-calibre, experienced lawyers on a part-time and/or flexible basis. The Legal Director is ideal if you...
-
In House Counsel
Found in: Appcast Linkedin GBL C2 - 2 weeks ago
United Kingdom The Legal Director Full timeWe are looking for UK-based senior business lawyers who are qualified in England & Wales with significant in-house experience and at least 10 years PQE.Selling legal services in a way that no-one else does, The Legal Director provides businesses with high-calibre, experienced lawyers on a part-time and/or flexible basis. The Legal Director is ideal if you...
