Quality System Manager
Company: Neo Consulting Group LLC
Posted on: June 25, 2022
Our client is seeking to hire a Pharmaceutical Quality System
(PQS) Manager , who will be responsible for establishing PQS in
accordance with ICHQ10 and cGMP guidelines. Provide Quality
Assurance partnership with global quality partners, site
management, and SMEs to establish an efficient and effective cGMP
compliant PQS. The successful candidate will partner with other
areas within the project, as well as QA departments at other sites
to leverage existing PQS systems, processes, procedures, and
documents, where possible, to provide efficient, effective, agile,
and aligned QA PQS strategies and procedures.
Once in operations, the successful candidate will lead a team of QA
PQS SMEs responsible for ensuring that systems and processes are
maintained in a compliant state throughout the product lifecycle,
with a focus on consistent operational monitoring (performance
indicators) and continuous improvement. Additionally, the position
will lead and participate in client audits and regulatory agency
Deliver effective monitoring and control systems for process
performance and product quality, thereby providing assurance of
continued suitability and capability of processes. The PQS Lead
will establish PQS procedures and manage the primary PQS systems
including the system elements (such as complaints, deviations,
audits, and inspections) but are not limited to the following.
Corrective Action and Preventive Action
Process Performance and Product Quality Monitoring System
International and domestic travel required
You should expect the role and responsibilities to develop and
evolve as the project group expands and subsequently moves into
Have current knowledge of Biotech Drug Substance and Drug Product
multinational cGMP requirements to support the PQS and cGMP
operations for the site.
10+ years of PQS Biotech experience with establishing harmonized
PQS systems in a global network some of which include time in a
leadership role, prefer additional cross functional experience in
other operational areas such as manufacturing, QC, engineering,
Capable of partnering to assure suitability and/or cGMP compliance
of the PQS and ability to defend these systems to the customer and
Have excellent communication/presentation skills, and be able to
articulate complex information to stakeholders and partners that
utilize PQS systems including regulators and customers.
Experience with complex projects and the ability to keep work pace
and meet deadlines with good organization and planning skills.
The Company requires that the successful candidate hired for this
position be fully vaccinated for COVID-19, absent being granted an
accommodation due to medical, pregnancy, or sincerely held
religious belief or other legally required exemption.
Keywords: Neo Consulting Group LLC, Raleigh , Quality System Manager, Executive , Raleigh, North Carolina
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