Quality System Manager

Company: Neo Consulting Group LLC
Location: Raleigh
Posted on: June 25, 2022

Job Description:

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 inspections.

Job Responsibilities
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.
Change Management
Corrective Action and Preventive Action
Process Performance and Product Quality Monitoring System
Management Review
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 operations.

Preferred Requirements
Have current knowledge of Biotech Drug Substance and Drug Product multinational cGMP requirements to support the PQS and cGMP operations for the site.

Requirements
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, etc.
Capable of partnering to assure suitability and/or cGMP compliance of the PQS and ability to defend these systems to the customer and regulatory partners.
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