Manager, Quality Operations

PCI Pharma Services•Rockford, IL

About The Position

Responsible for managing the daily operations of the IQA Receiving and Quality Operations Departments through Supervisors, Leads, Auditors, and Inspectors, and for quality issues and events across all shifts. The Manager provides leadership, training, and guidance; ensures staffing and production demands are met; manages departmental budgets and growth plans; and monitors quality metrics and performance goals. This role serves as the primary Quality contact for business units regarding operational issues and provides 24-hour support for Quality-related issues by phone or email. The position oversees incoming, in-process, and finished-goods inspections; non-conforming products and materials; batch-record right-first-time activities; the Pest Control Program; Mean Kinetic Temperature and Environmental Monitoring; and retention samples and outbound retain shipments. It supports audits, investigations, product reviews, troubleshooting, new product development, and change controls, while driving continuous improvement and harmonization initiatives across facilities. The role reports potential Quality risks to Senior Management and ensures adherence to PCI, cGMP, and GCP policies and procedures. Overtime and/or weekend work may be required.

Requirements

Bachelor's degree in a related field and/or 1–5 years of related experience and/or training.
College-level mathematical skills.
Intermediate computer skills, including the ability to perform more complex computer tasks and knowledge of various computer programs.
Full professional proficiency in speaking, reading, and writing fluently and accurately for professional needs.
Very high reasoning ability, including defining problems, collecting data, establishing facts, drawing valid conclusions, interpreting technical instructions in mathematical or diagram form, and handling abstract and concrete variables.
High standard of report writing.
Ability to work overtime and/or weekends when required.
Knowledge of and adherence to PCI, cGMP, and GCP policies, procedures, and rules.

Nice To Haves

Ability to effectively present information to various people as required by the job.
Willingness to make decisions.
Excellent time-management skills.
Ability to work independently and/or as part of a team.

Responsibilities

Lead and guide department staff, ensuring they understand their tasks, responsibilities, business goals, and customer demands.
Provide 24-hour support for Quality-related issues by phone or email.
Monitor processes, performance, and behaviors, with a focus on continuous improvement.
Manage departmental budgets and plans for business growth.
Compile, analyze, and report departmental Quality metrics, including Product HOLDs, Line Clearance Observations/Failures, Near Miss events, and Right First-Time metrics.
Support customers and internal stakeholders through communications, business reviews, meetings, tours, audits, and investigations.
Facilitate Annual Product Reviews and deliver customer satisfaction.
Participate in tours of functional areas for internal, customer, and regulatory audits; identify risks, observations, and controls; communicate results; and develop action plans.
Provide training and presentations to associates as needed, including hands-on training for Quality functions.
Ensure staffing and production demands are met and Quality issues are resolved appropriately; report results to Quality and Production Management.
Develop, review, and approve department change controls for Standard Operating Procedures, Job Aids, Batch Records, Material Specifications, and Forms.
Facilitate troubleshooting of departmental testing equipment and work with vendors to resolve errors.
Collaborate with Project Management on New Product Development, including batch record documentation and successful product launches.
Oversee incoming, in-process, and finished-goods inspections to ensure products conform to established standards.
Investigate root causes of quality events and defects and recommend solutions.
Oversee Incoming Quality Inspection and Quality Operations functions.
Manage non-conforming products, materials, and reports, including NMRs, Product HOLDs, and Line Clearance Failures.
Manage the Batch Record Right First-Time program.
Ensure compliance for onboarding and training new Quality team members.
Partner and collaborate with functional departments.
Order or approve supply requisitions.
Oversee the Pest Control Program, Mean Kinetic Temperature, and Environmental Monitoring.
Serve as the primary Quality contact for business units regarding operational issues.
Oversee PCI and customer retain samples, the retain cage, and outbound retain shipments.
Prepare periodic and special reports on departmental activities, problems, quality systems, and schedules.
Lead and drive improvement and harmonization initiatives across multiple facilities.
Ensure Safety, Quality, Regulatory, and Delivery performance metrics and objectives are on track.
Report and escalate potential risks affecting Quality to Senior Management.
Adhere to PCI, cGMP, and GCP policies, procedures, and rules; maintain attendance as an essential job function.
Perform other duties as assigned by the Manager.