Manager, Quality Operations

PCI Pharma Services; Rockford (IL); On-site; USD 85,000 - 120,000; Full time

Job summary

PCI Pharma Services in Rockford, IL is seeking a seasoned Quality Operations Manager to oversee the IQA Receiving and Quality Operations departments across shifts. You will drive continuous improvement, manage budgets, and lead audits and change controls to ensure product quality and regulatory compliance.

The role requires strong leadership, ability to coordinate with multiple functional departments, and hands-on training of staff.

Responsibilities

• Provide knowledge, training, leadership, motivation, and guidance to ensure staff have a clear understanding of tasks, responsibilities, business goals and customer demands.
• Provide 24-hour support for Quality related issues either by phone or email.
• Be observant of processes, performance, and behaviors, focusing on continuous improvement.
• Manage budgets and plans for business growth.
• Compile, analyze and report key departmental Quality metrics (Product HOLDs, Line Clearance Observations/Failures, Near Miss events and Right First-Time metrics).
• Provide support via emails, phone, Quarterly Business Review/meetings, tours, audits, and investigations.
• Facilitate Annual Product Reviews. Deliver customer satisfaction.
• Perform and participate in tours of functional areas for internal, customer and regulatory audits. Identify risks, observations, and controls. Communicate results and develop action plans to resolve issues.
• Provide training and presentations to all associates as needed.
• Ensure headcount, staff and production demands are met.
• Ensure Quality issues are resolved appropriately and report results to Quality and Production Management.
• Responsible for developing, review and approve department Change Controls for Standard Operating Procedures, Job Aids, Batch Records, Material Specifications and Forms.
• Responsible for facilitating troubleshooting issues for the department's testing equipment and or work with vendors to resolve errors.
• Collaborate with Project Management for New Product Development; ensuring batch record documentation and product launches are successful.
• Oversee incoming, in-process and finished goods inspections of products to ensure conformance to established standards.
• Investigate root causes of quality events/defects and recommending solutions.
• Oversee functions of Incoming Quality Inspection and Quality Operations.
• Manage non-conforming products, materials, and reports (NMRs, Product HOLDs, Line Clearance Failures).
• Manage Batch Record Right First-Time program.
• Ensure compliance for onboarding and training new Quality team members.
• Ability to partner and collaborate with functional departments.
• Order and or approve supply requisitions.
• Oversee Pest Control Program.
• Oversee Mean Kinetic Temperature and Environmental Monitoring.Primary Quality Contact for Business Units regarding operational issues.
• Oversee retention of PCI, customer retain samples (retain cage) and outbound retain shipments.
• Provide hands-on training ensuring employees are trained to quality functions.
• Prepare periodic and special reports concerning departmental activities, problems, quality systems, schedules, etc.
• Lead and drive improvement / harmonization initiatives across multiple facilities.
• Ensure Performance Metrics (Safety/Quality/Regulatory/Delivery), goals and objectives are on track for completion.
• Report and escalates to Senior Management of any potential risks that impact Quality.
• This position may require overtime and/or weekend work.
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
• Attendance at work is an essential function of this position.
• Performs other duties as

Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Summary of Objective:

Responsible for managing daily operations of the IQA Receiving and Quality Operations Departments through the activities of the Supervisors, Leads, Auditors and Inspectors. Responsible for the quality issues/events that occur on all shifts.

Essential Duties and Responsibilities:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• Provide knowledge, training, leadership, motivation, and guidance to ensure staff have a clear understanding of tasks, responsibilities, business goals and customer demands.
• Provide 24-hour support for Quality related issues either by phone or email.
• Be observant of processes, performance, and behaviors, focusing on continuous improvement.
• Manage budgets and plans for business growth.
• Compile, analyze and report key departmental Quality metrics (Product HOLDs, Line Clearance Observations/Failures, Near Miss events and Right First-Time metrics).
• Provide support via emails, phone, Quarterly Business Review/meetings, tours, audits, and investigations.
• Facilitate Annual Product Reviews. Deliver customer satisfaction.
• Perform and participate in tours of functional areas for internal, customer and regulatory audits. Identify risks, observations, and controls. Communicate results and develop action plans to resolve issues.
• Provide training and presentations to all associates as needed.
• Ensure headcount, staff and production demands are met.
• Ensure Quality issues are resolved appropriately and report results to Quality and Production Management.
• Responsible for developing, review and approve department Change Controls for Standard Operating Procedures, Job Aids, Batch Records, Material Specifications and Forms.
• Responsible for facilitating troubleshooting issues for the department's testing equipment and or work with vendors to resolve errors.
• Collaborate with Project Management for New Product Development; ensuring batch record documentation and product launches are successful.
• Oversee incoming, in-process and finished goods inspections of products to ensure conformance to established standards.
• Investigate root causes of quality events/defects and recommending solutions.
• Oversee functions of Incoming Quality Inspection and Quality Operations.
• Manage non-conforming products, materials, and reports (NMRs, Product HOLDs, Line Clearance Failures).
• Manage Batch Record Right First-Time program.
• Ensure compliance for onboarding and training new Quality team members.
• Ability to partner and collaborate with functional departments.
• Order and or approve supply requisitions.
• Oversee Pest Control Program.
• Oversee Mean Kinetic Temperature and Environmental Monitoring.Primary Quality Contact for Business Units regarding operational issues.
• Oversee retention of PCI, customer retain samples (retain cage) and outbound retain shipments.
• Provide hands-on training ensuring employees are trained to quality functions.
• Prepare periodic and special reports concerning departmental activities, problems, quality systems, schedules, etc.
• Lead and drive improvement / harmonization initiatives across multiple facilities.
• Ensure Performance Metrics (Safety/Quality/Regulatory/Delivery), goals and objectives are on track for completion.
• Report and escalates to Senior Management of any potential risks that impact Quality.
• This position may require overtime and/or weekend work.
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
• Attendance at work is an essential function of this position.
• Performs other duties as