Production Compliance Manager

Production Compliance Manager

Requirements

• Minimum B.Sc. in Microbiology, Biochemistry, Engineering, Biotechnology or Related Science
• A minimum of two (2) years (four years preferred) of previous relevant experience in Commercial Manufacturing, Manufacturing Technology, Quality Operations or similar role
• High level of knowledge of cGMPs in pharmaceuticals/biological manufacturing environment
• Experience in regulatory inspections an asset
• Good problem-solving skills
• Must possess excellent communication, technical writing, and organization skills
• Six-sigma or other root cause training and experience an asset
• Knowledge and experience with multiple software programs such as Word, Outlook, Visio, and PowerPoint

Responsibilities

• Determine the scope of the investigation by collaborating with Quality Operations (QO), Manufacturing and Subject Matter Experts (SME) as appropriate in real time on the shop floor
• Lead and develop an investigation strategy in collaboration with Manufacturing, Quality Operations, and SMEs
• Perform Root Cause Analysis by conducting Shop Floor Production Walkthrough (GEMBA), select appropriate analytical tools, collect, and analyze data to determine the true root cause
• Identify expertise required for the investigation (MSAT, Process Engineering, C&Q, Technical Services, QC, QOVS, QOSA, etc.), co-ordinate and manage contributions from other departments
• Review and provide guidance on reports prepared by technical staff
• Prepare manufacturing investigations to support other functional areas as requested
• Write and manage associated documentation, actions and timelines
• Responsible to ensure that investigation reports and/or manufacturing investigation reports are clear, concise, and comprehensive
• Manage the deviation review process and ensure deviation investigations are closed according to targeted timelines
• Ensure actions are assigned to the appropriate individuals and completed to meet timelines
• Support investigation of non-conformances during project phase, identify root cause, and work with the team to identify and implement appropriate corrective actions
• Support shop-floor execution of Engineering/Development/Process Performance Qualification (PPQ) and Environmental Monitoring Process Qualification (EMPQ) protocols, as needed
• Initiate and manage change control requests affecting the B200 Flu Manufacturing department
• Collaborate with assessors for evaluation of changes
• Ensure timely closure of change controls
• Track and monitor change control progress
• In collaboration with platform management and other stakeholders, develop appropriate CAPAs with a clearly defined scope to address the root cause
• Initiate CAPAs in the Quality System as required
• Support manufacturing staff on updating GMP documents arising from CAPAs
• Review CAPAs associated with recurring issues and escalate any issues to Platform Leaders
• Work with Platform Leaders to identify and develop process improvements to remediate risks
• Work with SMEs and appropriate QO experts; develop assessment of risk to product, process and other stages
• Utilize the Deviation Review Board Governance as required
• Prepare for Regulatory inspections by drafting investigation briefing packages / hot topics as applicable
• Present and defend investigations and provide support to the area manager for process / procedure topics during Regulatory inspections and other audits
• Lead and manage Data Integrity activities, initiatives, and continuous improvements within the Platform in collaboration with APT Support teams and QOVS
• Perform Shop Floor Production Walkthroughs (GEMBA) to identify compliance gaps
• Track and develop action plan to address gaps, as required
• Act as Administrator for standalone equipment and ensure compliance with regular user access reviews, as well as audit trail backup and storage
• Lead continuous improvement initiatives as outputs of investigations and provide compliance direction and monitoring as related to Shop Floor operations
• Participate in special projects for production process improvements to meet GMP requirements and/or address inspection observations
• Provides metrics and other reports as required
• Support GMP Documentation review (eBPRs, logbooks, etc.) as required

Preferred Qualifications

• Experience in regulatory inspections an asset
• Six-sigma or other root cause training and experience an asset