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 other applicable industry standards.
- Lead the Quality and Compliance department, 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.
Qualifications:
- 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.
- Comprehensive knowledge of regulatory requirements and industry standards applicable to personal care products.
- Proven track record of implementing and managing a QMS in a manufacturing environment.
- Experience in submission of at least one of the following: 510k / PMN medical device, IND, NDA, or ANDA.
Preferred Qualifications:
- 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.
- Proficiency with Microsoft Office.
Job Type: Full-time
Pay: $170,000.00 - $210,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
Ability to Commute:
- Minneapolis-Saint Paul, MN (Required)
Ability to Relocate:
- Minneapolis-Saint Paul, MN: Relocate before starting work (Preferred)
Work Location: In person