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Quality Assurance Manager
$113k-146k (estimate)
Full Time | Pharmaceutical 3 Weeks Ago
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Bell International Laboratories is Hiring a Quality Assurance Manager Near Eagan, MN

Description

Position Overview: We are seeking an experienced Quality Assurance and Regulatory Compliance Manager to lead our quality and regulatory team in the personal care industry. This role combines a strong foundation in quality assurance with a deep expertise in regulatory compliance, including organizing and facilitating regulatory matters with government and beauty industry authorities. This role demands a professional with a strategic mindset for continuous improvement, a commitment to excellence, and the ability to manage multiple projects with high accuracy and attention to detail.

Key Responsibilities:

  • Develop, implement, and manage quality assurance policies and procedures, ensuring compliance with international standards and regulatory requirements.
  • Lead and manage the quality and regulatory team, fostering a culture of high performance, continuous improvement, and collaborative teamwork.
  • Oversee the entire quality assurance process, including audits, inspections, and testing to ensure product integrity and quality.
  • Serve as the primary point of contact for all quality-related inquiries and issues, including liaising with external regulatory bodies and auditors.
  • Utilize expertise in regulatory compliance to successfully register products, ensuring compliance with FTC/FDA rules and regulations.
  • Collaborate with cross-functional teams to address quality issues, implement corrective actions, and ensure that quality objectives are achieved.
  • Conduct regular reviews and updates of QA policies and procedures to adapt to new regulations and industry best practices.
  • Provide regulatory feedback to R&D regarding proposed product ingredient lists and collaborate with Marketing and Creative teams to ensure global compliance.
  • Manage and maintain the Quality Management System (QMS), ensuring documentation is up to date and in compliance with regulatory standards.

Required Skills/Abilities:

  • Demonstrated ability to understand, explain, and apply FDA consumer product regulations, with knowledge of FTC regulations being a plus.
  • Excellent written, verbal, and interpersonal communication skills, with the ability to prioritize multiple responsibilities and manage deadlines accordingly.
  • Proactive nature with a strong desire to learn and develop in the role, coupled with acute attention to detail and high level of organization and accuracy.
  • Ability to work autonomously and across teams, developing and maintaining professional and courteous working relationships with global partners.

Required Education and Experience:

  • Bachelor’s degree in a relevant field such as Quality Management, Engineering, Science, Chemistry, Biology, Life Sciences, Legal, or Regulatory Affairs.
  • A minimum of 5 years of experience managing a quality and regulatory team within a regulated industry, with at least 3 years regulatory/compliance experience in the personal care product industry.
  • Demonstrated expertise in Quality Management Systems (QMS) and thorough understanding of regulatory standards such as ISO 9001, FDA, EMA, etc.
  • Hands-on experience with international product registration and labeling requirements.

Preferred Qualifications:

  • Master Degree is a plus
  • Notary public qualification/license advantageous.
  • Foreign language skills and experience with related databases are a plus.

Job Summary

JOB TYPE

Full Time

INDUSTRY

Pharmaceutical

SALARY

$113k-146k (estimate)

POST DATE

04/05/2024

EXPIRATION DATE

06/04/2024

WEBSITE

bellinternationallabs.com

HEADQUARTERS

EAGAN, MN

SIZE

200 - 500

FOUNDED

2010

CEO

MO SAREMI

REVENUE

$50M - $200M

INDUSTRY

Pharmaceutical

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