Gcp Quality And Compliance Manager
5 giorni fa
Meditrial is a full-service digital research organization with a foundation in clinical trial research, education, regulatory and market access.
Meditrial has been leading the medical tech industry by delivering unparalleled outcomes for innovators.
Our successful track record supporting medical device and biotechnology companies in all phases of clinical development puts us in a prime position to seize the opportunity to emerge as a leader in digital technology with the promise that it will enhance and alleviate the clinical trial and participant burden.
Through our work, the patient and innovator are empowered with data and insights across the lifecycle of product development and market penetration changing the paradigm of care towards understanding and value.
Meditrial, as a recognized leader in the medtech field participates in the development of global standards, policies and regulations.
We have the ability to transcend the current landscape with "smart" technology enabled data collection tools and insights that are being regulated by the medical device "rule book".
It is our belief that the future of traditional therapeutics and the treatment paradigm will include medical device regulation
- Some examples to name a few: Drug Delivery Systems, Companion Diagnostics, Digital Apps, Wearables, AI enabled pills, Precision dosing tools, Clinical assessment technology etc.
With over a decade of history, operating throughout Europe to manage trials sponsored by global companies, we offer highest level expertise across multiple therapeutic areas including notable depth in cardiovascular and respiratory, orthopedics, oncology, CNS, infectious disease, endocrinology, diabetes, among other indications.
We are passionate about our mission to support the innovation and development of better therapies in healthcare in compliance with solid ethical standards.
Our commitment has resulted in excellent results for business growth by creating stability and opportunities for employees and collaborators.
**GCP Quality and Compliance Manager**:
The Quality GCP and Compliance manager will provide compliance expertise and work with quality management, external auditors, in conjunction with the clinical department to ensure GCP and GVP compliance across all Meditrial projects.
Additionally, the position will be responsible for implementing clinical compliance plans to include external GCP and GVP audits of clients, suppliers, and investigator sites, as well as internal audit of clinical processes and procedures.
The role will report to the Chief Medical Officer and Global Head of Regulatory and Quality.
**Responsibilities**:
Formulate GCP compliance strategy and provide advice for all programs within Meditrial
Assess GCP and GVP compliance risk areas and develop and implement risk mitigation measures.
Develop and prioritize an audit strategy for all programs
Plan and lead GVP and GLP compliance audits (US and international), including clinical investigator sites, contract clinical laboratories and all clients to determine compliance status and identify compliance risks
Report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented and documented
Partner with Clinical Development, Clinical Operations, Nonclinical and Regulatory Affairs stakeholders regarding compliance issues and provide compliance guidance to audited parties to encourage process improvement, serve as an expert in the interpretation of GCP and GVP regulatory requirements and expectations
Manage QA reviews of project-related of essential clinical study documents
Manage regulatory authority inspections and the coordination of responses to resolve inspection findings, if any
Lead GCP/GVP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials and nonclinical studies
Develop and implement standards, policies, and procedures for GCL/GVP regulatory compliance
Report and escalate compliance issues to management, including requests for directed audits
Participate in quality and compliance improvement initiatives within and outside of Clinical Development/Clinical Operations departments
Provide guidance, interpretation and information on GCP and GVP regulations, standards and quality systems
Prepare internal QA reports, provide input for external partners/ clients
Preferred Experiences & Requirements
BS/BA degree in scientific discipline from an accredited college or university or equivalent experience.
Advanced degree preferred
8 to 10 years of relevant pharmaceutical industry experience, with a minimum of 5 years of GCP compliance, preferably in an FDA regulated environment
Experience in the large pharmaceutical industry and start up environment preferred
Experience in planning and conducting GCP and GVP audits
Experience with regulatory inspections and inspection readiness (EU experience is a plus)
Experience with Qua
-
Gxp Quality And Compliance Manager
2 giorni fa
Lazio, Italia Meditrial Europe Ltd. A tempo pienoMeditrial is a full-service digital research organization with a foundation in clinical trial research, education, regulatory and market access.Meditrial has been leading the medical tech industry by delivering unparalleled outcomes for innovators.Our successful track record supporting medical device and biotechnology companies in all phases of clinical...
-
Quality Compliance Manager
1 mese fa
Lazio, Italia Teva Pharmaceuticals A tempo pienoWho we are TAPI is the leading international supplier of active pharmaceutical ingredients (APIs).With the industry's broadest portfolio including over 350 API products, we are the go-to global supplier for APIs, supporting 80% of top 50 global pharmaceutical companies.We are proud of our reliable history in the generic API industry dating back over 80...
-
Quality Compliance Manager
2 settimane fa
Lazio, Italia Buscojobs A tempo pienoWho we are TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industry's broadest portfolio including over 350 API products, we are the go-to global supplier for APIs, supporting 80% of top 50 global pharmaceutical companies. We are proud of our reliable history in the generic API industry dating back over 80...
-
Quality Compliance Manager
4 settimane fa
Lazio, Italia Tevapharm A tempo pienoTAPI is the leading international supplier of active pharmaceutical ingredients (APIs).With the industry's broadest portfolio including over 350 API products, we are the go-to global supplier for APIs, supporting 80% of top 50 global pharmaceutical companies.We are proud of our reliable history in the generic API industry dating back over 80 years, and the...
-
Quality Manager
23 ore fa
Lazio, Italia Quasar Srl A tempo pieno**Quality Manager**:**Responsibilities**:- Ensure the Quality assurance on the project and coordinate all quality activities throughout the project, according to.- Prepare Project Quality Plan and support on the definition of specific procedures/plans for the project, according to corporate procedures and to customer requirements- Coordinate quality...
-
Lazio, Italia Antal International Network A tempo pienoJob DescriptionAntal International is a Multinational Headhunting Company with more than 140 offices in 40 countries.Life Science is a Team specialized in profiles with a Scientific and Engineering background in Manufacturing, Production, Engineering, SCM, Research and Development, Medical, Quality and Technical-Commercial in Pharmaceutical, Pharmaceutical...
-
Compliance Manager
2 settimane fa
Lazio, Italia Buscojobs A tempo pienoWe are currently looking for a Compliance Manager to join our fast growing and dynamic team. The Compliance Manager will be responsible for assisting the Head of Compliance and MLRO with overseeing and managing the Institution's compliance risks, ensuring compliance with regulatory requirements and providing effective guidance to the various functions on...
-
Compliance Manager
1 mese fa
Lazio, Italia Buscojobs A tempo pienoWe are currently looking for a Compliance Manager to join our fast growing and dynamic team.The Compliance Manager will be responsible for assisting the Head of Compliance and MLRO with overseeing and managing the Institution's compliance risks, ensuring compliance with regulatory requirements and providing effective guidance to the various functions on...
-
Compliance Manager
1 mese fa
Lazio, Italia Buscojobs A tempo pienoWe are currently looking for a Compliance Manager to join our fast growing and dynamic team. The Compliance Manager will be responsible for assisting the Head of Compliance and MLRO with overseeing and managing the Institution's compliance risks, ensuring compliance with regulatory requirements and providing effective guidance to the various functions on...
-
QA Manager Global Audit and Due Diligence
2 giorni fa
Lazio, Italia Confidenziale A tempo pienoQA Manager Global Audit and Due Diligence - Abbott Pharma JOB DESCRIPTION: Abbott Established Pharmaceuticals (EPD) is looking for two QA Manager Global Audit and Due Diligence This Position can be hired within the EPD Locations in Italy, Germany, Ireland or Netherlands and will have travel of 30-50% globally Primary Job Function The role of the EPD QA...
-
Compliance And Ethics Lead, Italy
3 settimane fa
Lazio, Italia Bristol-Myers Squibb A tempo pieno**Working with Us**Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
-
Lazio, Italia Buscojobs A tempo pienoAmpaspace Quality Assurance Manager DeputyThe Aerospace Deputy Quality Assurance Manager is responsible for supporting the Quality Assurance Manager in ensuring compliance of EASA Part 21 / G Approved Production Organization with legal, regulatory, and normative obligations related to quality, including but not limited to ISO9001 and EN9100 standards as well...
-
Lazio, Italia Ppg México A tempo pienoAmpaspace Quality Assurance Manager Deputy The Aerospace Deputy Quality Assurance Manager is responsible for supporting the Quality Assurance Manager in ensuring compliance of EASA Part 21/G Approved Production Organization with legal, regulatory, and normative obligations related to quality, including but not limited to ISO9001 and EN9100 standards as well...
-
Ampaspace Quality Assurance Manager Deputy
2 settimane fa
Lazio, Italia Buscojobs A tempo pienoAmpaspace Quality Assurance Manager Deputy The Aerospace Deputy Quality Assurance Manager is responsible for supporting the Quality Assurance Manager in ensuring compliance of EASA Part 21 / G Approved Production Organization with legal, regulatory, and normative obligations related to quality, including but not limited to ISO9001 and EN9100 standards as...
-
Compliance Manager
4 settimane fa
Lazio, Italia Metawealth A tempo pienoAbout MetaWealth MetaWealth is a WEB3 investment platform that revolutionizes real estate investment by tokenizing assets through blockchain technology. We transform physical properties into digital tokens representing ownership stakes, lowering the entry barriers for investors and enhancing transparency, security, and efficiency through the use of smart...
-
Compliance Manager
3 mesi fa
Lazio, Italia Metawealth A tempo pienoAbout MetaWealth MetaWealth is a WEB3 investment platform that revolutionizes real estate investment by tokenizing assets through blockchain technology. We transform physical properties into digital tokens representing ownership stakes, lowering the entry barriers for investors and enhancing transparency, security, and efficiency through the use of smart...
-
Stem It
2 mesi fa
Lazio, Italia Prysmian Group A tempo pienoSTEM IT - Project Quality Manager We are looking for a Project Quality Manager , who will report to the Project Quality and HSE Director of the Business Unit Projects (Powerlink, part of Prysmian Group) and will be based in our HQ in Milan, Italy.The Project Quality Manager main tasks are to plan and implement quality activities within projects, coordinate...
-
Stem It
2 settimane fa
Lazio, Italia Buscojobs A tempo pienoSTEM IT - Project Quality Manager We are looking for a Project Quality Manager, who will report to the Project Quality and HSE Director of the Business Unit Projects (Powerlink, part of Prysmian Group) and will be based in our HQ in Milan, Italy. The Project Quality Manager's main tasks are to plan and implement quality activities within projects, coordinate...
-
Stem It
2 settimane fa
Lazio, Italia Buscojobs A tempo pienoSTEM IT - Project Quality Manager We are looking for a Project Quality Manager, who will report to the Project Quality and HSE Director of the Business Unit Projects (Powerlink, part of Prysmian Group) and will be based in our HQ in Milan, Italy. The Project Quality Manager's main tasks are to plan and implement quality activities within projects, coordinate...
-
Worksite Quality Manager
2 settimane fa
Lazio, Italia Alstom A tempo pienoReq ID:447004Leading societies to a low carbon future, Alstom develops and markets mobility solutions that provide the sustainable foundations for the future of transportation. Our product portfolio ranges from high-speed trains, metros, monorail, and trams to integrated systems, customised services, infrastructure, signalling and digital mobility solutions....
