Manager, Quality Operations
About The Position
The Manager, Quality Operations is 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 role provides leadership, training, and guidance to staff; monitors departmental performance and continuous improvement; manages budgets and plans for business growth; and reports departmental quality metrics and activities. The manager oversees incoming, in-process, and finished-goods inspections, quality investigations, non-conforming products and materials, batch-record right-first-time activities, onboarding and training, equipment troubleshooting, and quality programs including pest control, environmental monitoring, and sample retention. The position serves as a primary quality contact for business units, supports customers and audits, collaborates on new product development and product launches, and drives improvement and harmonization initiatives across facilities. The role may require overtime and weekend work.
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 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 meet attendance requirements and adhere to PCI, cGMP, and GCP policies, procedures, and rules.
Nice To Haves
- Ability to present information effectively to various audiences.
- Willingness to make decisions.
- Excellent time management skills.
- Ability to work independently and/or as part of a team.
Responsibilities
- Manage daily operations of the IQA Receiving and Quality Operations Departments through Supervisors, Leads, Auditors, and Inspectors, and address quality issues and events across all shifts.
- Provide staff with knowledge, training, leadership, motivation, and guidance on 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 stakeholders through email, phone, Quarterly 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 in quality functions.
- Ensure headcount, staffing, and production demands are met.
- Ensure quality issues are resolved appropriately and report results to Quality and Production Management.
- Develop, review, and approve departmental 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 to ensure batch record documentation and product launches are successful.
- 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 in 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 retention of PCI and customer retain samples and outbound retain shipments.
- Prepare periodic and special reports concerning 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, goals, and objectives are on track.
- Report and escalate potential risks that may impact Quality to Senior Management.
- Adhere to PCI, cGMP, and GCP policies, procedures, and rules; maintain required attendance; and perform other duties as assigned by the Manager.
Benefits
- Paid time off.
- Health insurance coverage, including dental and vision.
- Flexible spending account.
- 401(k).
- Eligibility for an annual performance bonus.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
