Plant Quality Manager - Lead Quality & Compliance

Corning Incorporated; Town of Oneonta (NY); On-site; USD 134,000 - 185,000; Full time

Benefits offered by this job

Bonuses and long-term incentives

Company-paid pension / 401(k) with 7-?

Health and wellness benefits

Paid time off

Job summary

Corning Life Sciences seeks a Plant Quality Manager to lead quality strategy, compliance, and continuous improvement at its Oneonta facility. You will build a culture of quality across the plant and influence safety, service and performance.

You will oversee QA/QC, regulatory audits, and cross-functional collaboration to align quality priorities with engineering, supply chain, finance and regulatory functions in a regulated manufacturing setting.

Qualifications

• Bachelor's degree in Life Sciences or Engineering.
• 10+ years of related quality experience.
• 5+ years of experience in a regulated manufacturing environment.
• Prior supervisory or managerial experience.
• Familiarity with 21 CFR Parts 820 and 211, ISO 9001, ISO 13485, and GAMP 5.
• Experience participating in regulatory audits and inspections.
• Knowledge across quality disciplines including validation, calibration, and quality control.
• Proficiency in Microsoft Office tools and EDMS.

Responsibilities

• Develop and lead the plant's strategic quality plan, ensuring compliance with ISO 9001, ISO 13485, 21 CFR Parts 820 and 211, USP, ASTM, cGMP, and GAMP 5 as applicable.
• Serve as the plant Management Representative for Notified Bodies; lead and host regulatory authority and customer audits and inspections, and ensure effective, timely resolution of findings
• Oversee quality assurance and quality control functions, including testing of raw materials, in-process materials, finished goods, and critical facility utilities
• Partner with plant leadership, engineering, supply chain, finance, and divisional quality and regulatory functions to align on quality priorities and drive continuous improvement across the plant
• Lead, coach, and develop the plant quality organization; conduct Management Reviews in collaboration with the Plant Manager and execute strategic quality assurance projects aligned with business objectives

Skills

Quality management

Regulated manufacturing

Leadership / supervisory

Quality systems

Statistical methods

Lean / Six Sigma

MS Office

EDMS

Education

Bachelor's degree in Life Sciences or Engineering

Tools

Electronic Document Management Systems

Job description

Corning Life Sciences seeks a Plant Quality Manager to lead quality strategy, compliance, and continuous improvement at its Oneonta facility. You will build a culture of quality across the plant and influence safety, service and performance.

You will oversee QA/QC, regulatory audits, and cross-functional collaboration to align quality priorities with engineering, supply chain, finance and regulatory functions in a regulated manufacturing setting.