Vice President of Quality

3 weeks ago

Saint Paul, United States Bell International Laboratories Full time

The Vice President of Quality and Regulatory Compliance is a critical leadership role responsible for setting and enforcing the highest standards of quality and compliance throughout all aspects of our manufacturing operations. This executive will lead our efforts to ensure that all products meet or exceed regulatory standards and customer expectations, driving continuous improvement in our processes and products.

Responsibilities

  • Develop and implement a comprehensive quality management system (QMS) that integrates all aspects of quality assurance, quality control, and compliance processes across the organization.
  • Ensure compliance with national and international regulations and standards related to personal care products, including FDA, EPA, ISO, and others applicable to the industry.
  • Lead the Quality and Compliance department, including setting objectives, budgeting, and staffing to effectively support the organization's goals and growth.
  • Establish and maintain a strong culture of quality and continuous improvement, including the adoption of best practices and innovative quality assurance technologies.
  • Oversee the management of audits, both internal and external, ensuring compliance with regulatory standards and identifying opportunities for process improvement.
  • Work closely with R&D, production, and supply chain teams to integrate quality and compliance considerations into product development and manufacturing processes.
  • Manage relationships with regulatory bodies and industry associations, staying ahead of changes in legislation and standards that could impact the company's products or processes.
  • Lead the response to quality or compliance issues, including product recalls, regulatory actions, and customer complaints, ensuring timely and transparent communication with all stakeholders.
  • Provide strategic leadership and guidance on quality and compliance matters to the executive team, contributing to the overall strategic direction of the company.

Required Skills/Abilities

  • Comprehensive knowledge of regulatory requirements and industry standards applicable to personal care products.
  • Strong leadership and organizational skills, with the ability to inspire and lead teams towards excellence.
  • Excellent communication and interpersonal skills, with the ability to interact effectively with all levels of the organization and external partners.
  • Strategic thinker with the ability to balance regulatory compliance with business objectives.
  • Acute attention to detail and high level of organization and accuracy
  • Proficient with Microsoft Office

Required Education and Experience

  • Bachelor’s degree in a related field (e.g., Chemistry, Biology, Engineering); Master’s degree or higher preferred.
  • Minimum of 10 years of experience in quality assurance/compliance roles within the personal care, pharmaceutical, or related manufacturing industries, with at least 5 years in a senior leadership position.
  • Experience in submission of at least one of the following: 510k / PMN medical device, IND, NDA, or ANDA
  • Proven track record of implementing and managing a QMS in a manufacturing environment.

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