Scope of Position:
The Quality Site Lead is accountable for product and process compliance to regulatory, customer and Corning Life Sciences standards. You will direct, plan and implement plant policies and procedures relating to Quality consistent with the Serum/ Solutions Center of Excellence, Divisional, and Corporate Quality/Regulatory programs and policies and ensures compliance with regulatory requirements. Responsible for ensuring that a quality system is maintained and continuously improved in accordance with ISO13485 and QSR CFR Title 21, Part 820. Plans, organizes, directs and coordinates all activities related to the management of product, process, and service quality. As a member of the management group, this position is responsible for the development of individual and organizational strategies. Responsible for reporting on the performance of the quality system to the Plant Leadership Team and identifying improvement strategies. Collaborates with Engineering and Operations to plan plant activities and projects that achieve process, quality, and cost improvement through Performance Excellence. Selects and develops competent employees to implement the activities of the Quality organization. Collaborates with the Commercial group to resolve customer complaints and to translate customer requirements into meaningful product specifications. Supports the site Plant Quality Manager and liaisons with regulatory authorities and customers, as needed, by hosting related audits and ensuring effective resolution of nonconformities under the direction of the Plant Quality Manager.
- Manage plant quality systems (including ISO documentation, records retention, etc.) and plant quality personnel to ensure that the plant’s products meet all customer requirements.
- Responsible for ensuring regulatory compliance to all aspects of ISO13485 and 21 CFR 820 and all applicable regulations and guidance documents.
- Leads the local Quality Management Team consisting of Quality Assurance, Quality Engineering, and Quality Control leads.
- Monitor customer feedback and corrective actions.
- Responds quickly and effectively to customer complaints and issues. Serves as the customer advocate in the plant.
- Collaborates with plant, Solutions PQM, and division innovation teams to evaluate new product needs and translate them to meaningful plant specifications.
- Identifies and defines all required measurement protocols.
- Works with process and product improvement teams regarding key product attributes to develop appropriate control strategies and feedback loops to make sure product attributes perform as expected.
- Drive Performance Excellence activities to quickly and effectively support improvement initiatives.
- Maintains and supports a high level of product, analytical, and process knowledge in both self and staff.
- Continuously improves quality function spending to help the plant lower its costs.
- Assists with managing department spending and budgets.
- Perform process capability analysis as needed.
- Provide statistical design and analysis services to internal plant departments.
- Assists with overseeing FDA, ISO and Customer audits and ensures responses to these audits are provided in a timely fashion; supports these activities under the direction of the Solutions Plant Quality Manager.
- Oversees the validation program and directly supports the Solutions Plant Quality Manager with regard to the site risk management procedure.
- Provide support for the regulatory approval for the manufacture of custom products; gathers necessary information regarding intended use of product and supports regulatory approval for development and labeling of new products and supports regulatory approval for all documents-both technical/marketing and controlled documents as needed.
- Supports duties that directly assist the site management representative per regulatory and ISO standards.
Hours of work/work schedule/flex-time:
- Standard business hours; Monday - Friday days
- Bachelor’s degree.
- Prefer in Life Sciences, Chemistry or Engineering
Required Years and Area of Experience:
- Minimum of 5+ years quality, engineering or operations experience within a manufacturing environment.
- At least 2+ years of managerial or supervisory experience.
- Knowledge of key statistical methods and proficiency in Continual Improvement methods.
- Knowledge of Medical device or pharmaceutical manufacturing and aseptic processes.
- Familiarity with 21 CFR parts, 820, 210/211, ISO13485.
- Audit/inspection experience.
- Strong knowledge base in all aspects of Quality including validation, calibration, and quality control.
- Knowledgeable in Microsoft Office tools, electronic document management and ERP systems.
- Has led teams to implement new processes.
- CQE certification
- Production or engineering management experience.
- Lean Six Sigma experience and/or certified Six Sigma
- Working knowledge and understanding of manufacturing related accounting and other financial systems including budget process
- Knowledge of US and international pharmaceutical and medical device regulations.
- Excellent interpersonal skills
- Proven supervisory experience/skills
This position does not support immigration sponsorship.