Clinical Quality Assurance Manager in King Of Prussia, PA

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compensation:

$80K - $100K

specialty:

Quality Management

experience:

5 - 7 years

Job Description

Job Description

The CQA Manager is a global role managing Global CQA activities in the respective regions (Asia-Pacific, Americas, EMEA, Japan) and globally, as required. Under supervision of the Head of CQA Operations, this position is responsible for planning, maintenance and implementation of the assigned Global R&D Quality Audit Program with focus on Pre-Clinical, Early Clinical and Clinical Development in his/her region. Under guidance of the Head of CQA Operations in the respective region this position is responsible for the execution and performance of the Global CQA Quality System elements in the assigned compliance area including: Management of CAPAs and Deviations, Inspection Preparation and Management, Change Management, Continuous Improvement, Compliance, Governance and Reporting, 3rd Party management, Regulatory Intelligence, Pre-Clinical/Clinical IT-Systems and Procedural Quality Assurance. This position will liaise and interface with global and regional cu

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Valid through: 2020-1-20

About CSL Limited

CSL Limited is a global specialty biotechnology company that researches, develops, manufactures and markets products to treat and prevent serious human medical conditions. CSLs product areas include blood plasma derivatives, vaccines, antivenom, and cell culture reagents used in various medical and genetic research and manufacturing applications. Founded in 1916 the Commonwealth Serum Laboratories, an Australian government body focused on vaccine manufacture. Under the first director, William Penfold, CSL commenced operation in the vacant Walter and Eliza Hall Institute building at the Melbourne Hospital in 1918, before moving to its purpose-built Parkville premises in the following year. After ongoing disputes with the Commonwealth Department of Health and its director, (John) Howard Cumpston, Penfold resigned in 1927 and was replaced by Frederic Morgan. Soon after Morgans appointment, CSL was drawn into a serious public health disaster when a batch of its diphtheria toxin-antitoxin was implicated in the deaths of 12 children in what became known as the 'Bundaberg tragedy' of 1928. Although CSLs manufacturing processes were absolved, its labelling procedures were seen to be in error, leading to an enduring focus on the highest standards across the facilitys production. In 1928 CSL also became involved in antivenene (antivenom) manufacture in conjunction with the snake venom research undertaken by Charles Kellaway at the Hall Institute. This led to the successful clinical testing of antivenene against tiger snake Notechis scutatus bite in 1930, and its commercial release in 1931. In 1934 the research on snake venoms was transferred from the Hall Institute to CSL under the direction of former snake showman, Tom 'Pambo' Eades. This represented the initiation of research at the laboratories – an outcome its directors had been seeking for over a decade. The relationship with the Hall Institute continued until World War II, particularly via joint projects on viral diseases including polio and influenza coordinated by Frank Macfarlane Burnet and Esmond 'Bill' Keogh. Keogh played an important role in the establishment of penicillin production at CSL in 1944 – a critical wartime achievement.[citation needed] The operation commenced plasma fractionation in 1952. Thereafter the range of antivenoms increased, including those against other snake species such as death adder (Acanthophis antarcticus) and the taipan (Oxyuranus scutellatus), plus spiders including the redback (Latrodectus hasselti) and – after much difficulty – the Sydney funnel-web (Atrax robustus). Much of this work, including the introduction in 1962 of a polyvalent antivenom against all of the major terrestrial Australian snakes, occurred under the direction of Saul Wiener, while from 1966 until the mid-1990s, venom research was coordinated by the eccentric but dedicated Struan Sutherland.[citation needed]
Total Jobs:
53
Total Experts:
10
Average Pay:
$141,938
Total value of jobs:
$27,820,000
% Masters:
34%
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