Senior Quality Expert / Compliance Lead
A job vacancy for a Senior Quality Expert/Compliance Lead has arisen at a leading global pharmaceutical company specialising in development of biological therapies. This company is one of the top 10 global pharmaceutical companies that operates in 140 countries worldwide and has market leading products in multiple therapy areas. This will be a contract position based in the company's Swiss office.
- Lead design and implementation of "Just-In-Time (JIT)" training concept for OMA in 3Q.
- Operate and monitor execution of JIT training in 4Q+.
- Advise Pharma Medical Affairs on JIT training implementation (TBC).
- Support OMA Global GxP Director on training management and operations (incl assignments and training compliance monitoring).
- Provide ad-hoc support to key projects (namely GEMS rollout, HCP Experience).
Skills and Requirements:
- Scientific qualification (PhD, MSc or Bachelor's Degree) in in an appropriate scientific discipline or quality-related field.
- An in-depth knowledge of the international pharmaceutical product development process.
- A minimum of 2 years' experience with GxP requirements, quality management system including risk management and regulatory requirements from main Heath Authorities.
- Expertise in the principles and practices of Quality Risk management and/or GxP audits.
- Able to understand and work with enterprise and functional systems & data
- Experienced in implementing and deploying projects/ changes in an organization
- A broad understanding of Quality Management, GCP / GVP and Risk Management processes
- A broad understanding of main Health Authorities standards (e.g. FDA, EMEA) and ICH regulations and guidelines.
- Proven self-starter with experience in building capabilities based on defined business needs across geography and functions.
- Pharma experience; FDA Knowledge is an Advantage
- Should be familiar with Quality management, Risk management, and documentations in a compliant way.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Tim Masson at +44 2038540237 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
A growing European Headquartered Global CRO is looking for an experienced Senior QA Manager - GCP.
A growing European Headquartered Global CRO is looking for an enthusiastic and experienced QA Manager - Freelance GCP/GVP.
A well-known international pharmaceutical company with sites around the globe is looking to hire a QA Officer.
£0.00 - £75000.00 per annum
A leading pharmaceutical company, developing and manufacturing respiratory medicines, is currently recruiting a Deputy Head of QA & QP based in the UK.
£0.00 - £80000.00 per annum
A leading provider of integrated pharmaceutical development services to the global healthcare market is currently recruiting a Qualified Person (QP) to work at their office in South Wale
Highly Competitive Salary
North Chicago, USA
Proclinical is currently recruiting for a Medical Information Specialist for a biopharmaceutical company located in North Chicago, IL.
A leading biotechnology company is seeking to recruit a Qualified Person to their office in London.
A worldwide biotechnology company situated in Switzerland and operating in over 70 markets worldwide is looking for a Quality Assurance Associate.
A leading biometrics CRO, supporting global pharma, biotech, medical device and animal health partners with innovative clinical development services, is currently recruiting a QA Manager.
A globally renowned pharmaceutical company is seeking to recruit a Senior Quality Assurance Manager to their office in Switzerland.