Requisition Number: 78688
Role PurposeCorning 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.
Key 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
Experiences/Education - Required- 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)
Experiences/Education - Desired- 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
This position does not support immigration sponsorship. The range for this position is $134,306.00 - $184,671.00 assuming full time status. Starting pay for the successful applicant is dependent on a variety of job-related factors, including but not limited to geographic location, market demands, experience, training, and education.
A job that shapes a life. Corning offers you the total package. Your well-being is our priority. Our compensation and benefits package supports your health and wellness, financial aspirations, and career from day one.
- Company-wide bonuses and long-term incentives align with key business results and ensure you are rewarded when the company performs well. When Corning wins, we all win.
- As part of our commitment to your financial well-being, we provide a 100% company-paid pension benefit with fixed contributions that grow throughout your career. Combined with matching contributions to your 401(k) savings plan, Corning's total contributions to your retirement accounts can reach between 7% and 12% of your pay, depending on your age and years of service.
- Our health and well-being benefits include medical, dental, vision, paid parental leave, family building support, fitness, company-paid life insurance, disability, disease management programs, paid time off, and an Employee Assistance Program (EAP) to support you and your family.
- Getting paid for our work is important, but feeling appreciated and recognized for those contributions motivates us much more. That's why Corning offers a recognition program to celebrate successes and reward colleagues who make exceptional contributions.
