Pharmaceutical Quality Systems Manager

Job Title: Pharmaceutical Quality Systems Manager

Location: New Brunswick, NJ - Hybrid
Type: Contract

Overview
Leading pharmaceutical company looking for a Pharmaceutical Quality Systems Manager. Ideal candidates should have 4+ years of experience in a Pharmaceutical based Quality role with Quality Systems.

Responsibilities:

Process Ownership
• The Quality Systems Manager will act as end-to-end Local Process Owner of one or more Quality Systems used within Global External Manufacturing
• Establish and maintain relationships and communication pathways with Global Process Owners and Global Process Leads for relevant systems
• Act as primary ExM representative at Global Community of Practice meetings
• Gather stakeholder input from within ExM on any Global Process changes or initiatives and represent the input back into the Global Network
• Own all elements of the process including relevant procedures / forms, training materials, SharePoint content, metrics where applicable
• Display technical knowledge of the process and understand risks/weaknesses in the system
• Responsible for ensuring the elements of the process are compliant with Regulatory requirements, Health Authority expectations and with COMPANY policies / global procedures where applicable
• Regularly review the process (trends metrics, trends observations, right first time (RFT), Design, optimization) for their effectiveness and provide feedback to the Quality management team for action and remediation
• Own relevant process issues - speak to trends / issues / exceptions at External Manufacturing Tier 3A and 3B Quality Council.
• Develop and implement pro-active continuous improvement plans for the process for example Value Stream Mapping and identification of weak elements, regulatory surveillance

Processes include Deviation Investigations, Corrective Action / Preventive Action (CAPA), Complaints, Change Control, Quality Risk Management, Documentation, Training, Audits & Inspections.

• There will be 5% travel associated with this role.

Required Qualification(s)
• A science related degree in Chemistry, Engineering or Biotechnology or equivalent
• A minimum of four (4) years experience in a pharmaceutical Quality related role, preferably within a Quality Systems team
• A strong working knowledge of GxP regulations in the European Union (EU), United States (US) and other relevant global markets
• Experience in leading or participation in project teams

• Experience with handling product complaints, change control and documentation in pharmaceutical/medical industry.
• Experience in infinity/Veeva Vault

Desirable
• Experience in a GxP Manufacturing site
• Lead investigator training

Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.