GCP Quality Assurance Manager
Location: GermanySIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Biotechnology and Pharmaceutical organization, based in Bayern Germany.
The company is a traditional and very well known pharmaceutical company with different types of medication
ROLE DESCRIPTION
GCP Quality Assurance Manager (m/f)
RESPONSIBILITIES
• Provide GCP advice on program and trial level as a study team member.
• Review and approve critical study documents
• Support authoring of IMP program specific risked based audit plan, review CAPAs; Request additional audits, as required
• Act as Auditor/audit report reviewer and CAPA reviewer on other clinical programs
• Supports self-inspection program for other programs
• Ensure central overview on Medical Affairs local trials, via review and approval of protocols. Collaborate with local QA on compliance issues.
• Ensures QA CRO oversight
• Supports QA GOP review, study specific GCP training
• Supports authority inspections as Quality SMEs for a trial
REQUIREMENTS
• Degree in Life sciences,
• Minimum 2 years of experience in Clinical Quality Assurance
• Work experience in Clinical Development department
• Experience with managing Authority inspections and Clinical Auditing experience
• Pharmacovigilance auditing experience desirable
• Good knowledge of global regulatory framework for Preclinical, Phase I-III
• Fluent English – written & spoken
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact admin admin.
