Job Description

Ainsley Search Group is seeking a Quality Manager with experience in regulatory affairs for a Global Chemical Manufacturing Company based in Essex County. The ideal candidate will report to the Director of Quality and Regulatory and lead a site quality team to maintain the QMS, cGMP, GFSI status, develop a quality assurance process across materials, testing, R&D, Manufacturing, Technical Services, operations, customer support, develop a KPI and CAPA process to drives CI and reduce recurring quality issues, further ensure compliances with ISO, regulatory, and quality standard with customers, This is a full-time, permanent opportunity with excellent career advancement path, company would like to develop the right individual to become their Director of Quality and they offer lucrative compensation, bonus and competitive benefit.

Responsibilities:

• Reports to Director of Quality and Regulatory lead a team of quality to manage QMS, cGMP, GFSI, Regulatory Compliance for the both the corporate and manufacturing plant, ensure process flow in compliance of ISO across suppliers, production, R&D, technical service, testing, packaging, operations, etc.
• Develop, validate materials testing and validation process for incoming, in-process and finished products, ensure product quality meets ISO standard and customer requirement.
• Support customer approval process, lead internal and external quality audits, troubleshoot approval issues and provide corrective action as need to facilitate the approval process.
• Create ad hoc system or statistical analysis reports, maintain and update quality documents and collaborate with cross functional teams in compliance with quality system.
• Develop, monitor KPI for process across R&D, Technical Service, testing, manufacturing, etc., conduct root cause analysis on non-conformance, return, re-work, rejection issues across suppliers, supply chain, production, packaging, etc., implement corrective action to drive improvement and reduce recurring quality issue.
• Collaborate with suppliers and monitor supplier quality and KPI, drive supplier performance improvement to further promote overall efficiency.
• Lead ISO and quality related training, be the change agent and provide coaching to staff on process improvement and changes.
• Support customers on quality issues, inquires, collaborate closely with customers to resolve quality issues and develop relations with customers.
• Provides hands-on, strategic quality leadership, and maintain the highest quality standards and product integrity, responsible for staffing planning, staff development for the Quality department.
• Collaborate with engineering, operations, production, vendor, and sales team to ensure all equipment, materials, processes, and personnel are properly informed about quality manual, procedure, and compliance.
• Be the primary interface with the ISO registrar, conduct ISO Audit, internal audit and external audits with customers, suppliers, etc.
• Lead regulatory affair and compliance based on HTS, TSCA, COO, ensure of compliance with Local, State, and Federal Requirements.
• Monitor, interpret, assess and develop compliance strategies to address emerging regulations that impact capability to manufacture, marketing, distribute, import, or export manufactured materials; provide regulatory expertise and knowledge as need to customers, internal customers, suppliers.
• Analyze manufacturing process flows and identify enhancements of quality, cost reduction and throughput.
• Collaborate with Global Quality Director to support standardization of quality procedure across company.

Qualifications:

• Bachelor’s degree in business, Engineering, or related field.
• 710+ years of hands-on leadership experience in Quality and Regulatory Management, exposure to FDA regulated materials and ingredients strongly preferred.
• Solid knowledge on statistical analysis process, RCA, corrective action, process improvement and SPC, experience in analytical equipment such as particle size, melt flow index, colorimetry, etc.
• Solid knowledge in global regulatory compliance and regulatory affairs concerning COO, HTS, TSCA, Registration, etc.
• Strong problem solving and analytical skills; strong communication and people skills, able to communicate with both internal and external customers.
• Ability to mentor and develop a team.

Compensation & Benefits:

• Competitive base salary
• Performance and Management Bonus
• 401K with match
• PTO and paid Holidays
• Medical, Dental and Vision Insurance
• Long-term/short-term disability
• Life Insurance
• Relocation Assistance
• Tuition Reimbursement

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