Plant Quality Manager, Oneonta

Corning•City of Oneonta, NY

3d•$134,306 - $184,671•Onsite

About The Position

Corning Life Sciences (CLS) is seeking a Plant Quality Manager to lead quality strategy, compliance, and continuous improvement at its Oneonta manufacturing facility. As a member of the Plant Leadership Team, this role is accountable for product and process compliance to regulatory, customer, and CLS standards — and for building a culture of quality across the plant. This is a high-impact leadership role with direct influence over plant safety, quality, service, and operational performance.

Requirements

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 Electronic Document Management Systems
Knowledge of statistical methods and continuous improvement methodologies (Lean / Six Sigma)

Nice To Haves

3+ years of experience in the pharmaceutical or medical device industry
Background in medical device or pharmaceutical manufacturing and sterilization
Demonstrated understanding and application of ISO 14971
ASQ certifications: Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or Certified Manager of Quality and Organizational Excellence (CMQOE)
Production or engineering management background

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