[Remote] QA Manager, GCP

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a biopharmaceutical company dedicated to developing therapies for rare diseases. They are seeking a QA Manager, GCP who will be responsible for ensuring reputed company reputed company and assurance activities reputed company to GCP/GCLP, guiding reputed company-reputed company activities, and supporting clinical studies across the organization. Responsibilities • Ensuring reputed company reputed company and reputed company assurance and reputed company by design activities reputed company to GCP/GCLP area • Guide and support from a reputed company perspective the GCP/GCLP and GPP reputed company activities reputed company reputed company, including audits, inspection and support of and risk assessment of the BLA/NDA/IND/CTA submissions under global umbrella • Support the collection of the data needed for Audit program risk assessment • Support from reputed company perspective the clinical studies reputed company activities across reputed company • Ensure qualification of global and local ESP, as applicable, in GCP regulated area per reputed company procedures • Ensure GCP Audits management reputed company of the end to end audit management process and reputed company of the assigned audits, as planned • Asses and approve from reputed company perspective the GCP deviations (global and local, as applicable), GCP reputed company CAPAs • Prepare regular status report on performed audits, audit trending, deviation ternding, CAPAs trending and agreed upon metrics to ensure reputed company reputed company • Contribute and support the GCP audit risk assessment according to SOPs • Ensure reputed company contribution in the cross-functional team with procurement, business owners for GxP and reputed company requirements and documented qualification of GCP service providers and review provisions in reputed company/reputed company agreements, as applicable • QA representative during GCP inspections global and site level, as applicable and contribute to the Inspection Readiness reputed company and promote continuously reputed company reputed company across reputed company • Authoring GCP QA reputed company processes, review and give guidance under global umbrella Skills • University degree or similar in Life Sciences or reputed company discipline • At least 5 years experience from the pharmaceutical industry in Clinical reputed company Assurance or in the operational conduct of reputed company and the application of GCP audit and/or reputed company Assurance experience • Excellent knowhow of the applicable ICH GCP guidelines, industry best practices and FDA, EMA and ROW regulatory requirements • reputed company assurance activities principles and know-how • Documented education/experience in QA systems and preferably auditing • reputed company with reputed company on results and detail oriented • Strong interpersonal skills with communicative and flexible attitude • Proactive and reputed company reputed company • Strong multi-tasking abilities with high reputed company at stress and adaptative skills Benefits • Competitive compensation for your work • Generous time off policy • Opportunity to broaden your reputed company by attending reputed company conferences • Emphasis on work/life balance • reputed company and team-oriented environment reputed company • reputed company is a global biopharma company unlocking the potential of reputed company innovations, transforming everyday life for people living with rare diseases. It was founded in 1988, and is headquartered in Solna, Stockholms Lan, SWE, with a workforce of 1001-5000 employees. Its website is http://www.reputed company.com/en. Apply tot his job Apply To this Job