Director Quality Regulatory Services

Summary: The Quality Director develops, designs, and implements, effective quality assurance systems to drive quality product performance and productivity to meet client expectations. This role handles the Product Approval Regulatory program to make sure regulatory and quality requirements are within compliance with current and upcoming regulations.

• Quality
  • Direct, plan and coordinate quality assurance of in-process products, documentation, and quality lab program systems to drive prompt product delivery for internal stakeholders, clients, and supplier quality programs.
  • Establish effective compliance requirements with written specifications to address non-conforming products.
  • Build and support client relationships that can be used to address, investigate, and set up corrective actions, and ensure accountability of suppliers for incoming product quality.
  • Partner with Supply Chain to qualify new suppliers, facilitate customer audits and provide follow-up actions for any necessary corrective actions.
• Regulatory
  • Direct regulatory processes to ensure new and existing products follow internal and external regulations and standards on time.
  • Monitors' regulatory requirements audit projects, plans and processes to include navigating and driving responses to regulatory changes.
  • Contribute to CDI (Consumer Driven Innovation), internal and external Project Team Meetings to review and analyze and share solution-driven recommendations.
  • Collaborate across global Schwan Cosmetics partners within Product Approval, Regulatory Affairs and Package Regulatory Teams to sustain up-to-date methods, testing, and product evaluation requirements for the cosmetics industry.
• Leadership
  • Direct, monitor, coordinate & supervise the quality, color lab and product approval department activities to maximize revenue and profitability.

• Drive effective cross functional team participation to proactively predict client needs, solve problems and build teams.

• Safety & Continuous Improvement
  • Lead and participate in continuous improvement efforts to enhance cost savings and improve product quality. Determine process capabilities for critical quality attributes and work with Engineering and Operations to improve process capabilities.
  • Engage in all safety activities to include ISO 14001, environmental compliance, and cGMP practices.

Minimum Qualifications

Education:

• Bachelor's degree in chemistry, Chemical Engineering, or related field of science.
• Black Belt Six Sigma is strongly preferred.

Experience:

• 10+ years of work experience directing regulatory compliance and quality management systems within a manufacturing work environment.
• 10+ years of work experience developing and leading a team to deliver high performance.
• Established experience utilizing SAP, and advanced Microsoft Office skills.
• Confirmed results driving compliance, results, and solutions.

• Experience with delivering solutions with data and business analysis.
• Proven effective communication skills, with tact, professionalism, and executive presence.
• Demonstrated experience in collaborating with internal and external customers.

Other: Must be able to pass a color hue test

Functional Competencies:

Business: Personal Product Regulations, FDA Knowledge, Scientific Concepts,

Technical: Regulatory Strategy Development, Data Management and Analysis, Product Planning, Market Knowledge Technical Management, Process and Procedures, Advanced Microsoft Office (MS PowerPoint, MS Word, MS Excel, MS Outlook)

Leadership: Communication, Self-Discipline, Integrity, Problem-Solving, Decision Making, Teamwork, Social Intelligence, Conflict Management, Change Management, Initiative, People Management