Quality Systems and Compliance Manager

West Pharmaceutical Services • Kinston, NC

2d • Onsite

About The Position

The Quality Systems and Compliance Manager monitors and controls daily quality inspection activities, including incoming and in-process inspections, final inspections, and batch record review and release. The role manages the Quality Control team and ensures inspections are performed properly and on time, procedures are followed, and processes are continually improved. It provides direct supervision of quality compliance supervisors and leads Quality Engineers, Audits, and Compliance Teams.

The manager promotes quality at the source and immediate audit readiness across manufacturing, including documentation and training. The role ensures compliance with quality system documents, cGMPs, ISO standards, and FDA regulations; supports product and process improvement; oversees investigations, corrective and preventive actions, documentation, equipment maintenance and calibration, and Quality Control metrics and training programs. This is an onsite position requiring attendance onsite on all scheduled workdays. Relocation assistance is offered. Travel is up to 5%, or 13 business days per year.

Requirements

• Bachelor's degree in a technical, engineering, or equivalent field.
• At least 8 years of experience in quality control.
• At least 3 years of supervisory experience.
• Ability to work assigned shifts and overtime as required to complete assignments.
• Ability to comply with company safety and quality policies.
• Ability to make decisions based on data analysis and exercise independent, sound judgment.
• Effective written and oral communication skills, including the ability to communicate with groups, interpret data, and understand and follow directions and established procedures.
• Organizational, multitasking, problem-solving, and prioritization skills; ability to work under time constraints and with others in varied situations.
• Ability to sit and/or stand for extended periods and lift and carry items up to 50 pounds for manufacturing positions.
• Where customer requirements necessitate it, ability to see with or without corrective lenses, distinguish color differences, and hear and react to audible alarms from up to 150 feet.

Nice To Haves

• Experience with metrology equipment.
• Ability to support and contribute to Lean Sigma programs and activities toward established targets.
• Certified Manager of Quality/Operational Excellence certification.

Responsibilities

• Provide direct supervision, resolve personnel issues, conduct performance evaluations, and administer discipline as necessary.
• Lead and direct Quality Engineers, Audits, and Compliance Teams.
• Promote a quality-at-the-source mentality across manufacturing, including documentation and training.
• Promote immediate audit readiness by ensuring records and actions are accurate, legible, and immediately retrievable.
• Ensure compliance with quality system documents, cGMPs, ISO standards, and FDA regulations.
• Schedule and prioritize quality inspection, testing, and batch record review and release to support Operations and product release.
• Identify opportunities to improve processes and procedures.
• Support quality assurance improvement activities by evaluating products, processes, or materials and developing control or improvement strategies.
• Work with technical staff on root cause failure analysis and corrective and preventive actions to prevent recurrence.
• Manage verbal communications and visual checks of work activity to ensure quality requirements are met.
• Ensure corrective actions, discrepancy reports, and follow-up activities are completed.
• Review documentation and records for accuracy, determine product impact and release eligibility, and determine whether a Non-Conformance Report is required.
• Manage development of documentation and procedures during qualification of new equipment and inspection methods.
• Create, prepare, implement, and improve Quality Control KPI metrics.
• Set goals and objectives for the Quality Control organization and training programs for team development.
• Support investigations related to non-conformances, audit observations, CAPAs, and issue reviews as needed.
• Ensure equipment is current on preventative maintenance and calibration activities.
• Maintain an organized lab or work area using a 5S mindset.
• Maintain regular, reliable, punctual, and predictable attendance, and perform other duties as assigned.

Benefits

• Relocation assistance.
• Volunteer opportunities through West without Borders and other charitable programs.
• Professional growth opportunities through training programs, tuition assistance, leadership development, and skill-certification initiatives.
• Flexible vacation, personal, and holiday leave.
• Global career opportunities, including international exposure and cross-functional collaboration.
• Inclusive and collaborative culture that values diversity, equity, and inclusion.
• Performance-based bonuses, service recognition, and employee appreciation initiatives.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager