Director of Quality Assurance and Compliance (ID:45920)

Are you looking to join a leading-edge and growing company with a forward-thinking approach? Our exciting, retained client has expanded a new part of its privately held business headquartered in the Minneapolis metro area. This privately held business supplies packaging and manufactures organic-certified beauty products. Reporting directly to the CEO, the successful candidate will lead quality and compliance worldwide and partner with executive leadership to help advance the goals of the company's extensive product line and standards.

Code: 45920

Posted: 2024-09-06

Category: Engineering & Operations

Our client is looking for a new Director of Quality Assurance and Compliance. This new leader will perform in a leadership and hands-on engineering and auditing capacity. The position is responsible for leading quality and regulatory initiatives, the quality team, and judgments based on knowledge and experience with processes, capabilities, industry standards, and customer expectations. This is a hands-on leader and customer-facing position to manage audits and address and resolve complaints.

Roles & Responsibilities:

Lead and manage the QC Operations organization, QC Analytical, and QC Microbiology activities to ensure efficient and high-quality release of products.
Develop and manage the new quality management system (Qualityze) for all operational processes.
Drive and support quality and compliance process creation and improvements.
Experience in ISO implementation and standards.
Lead CAPA, deviation, change control, customer complaints, SCARs, and continuous improvement activities.
Provide training and guidance to QA team members for routine QA rounds, as well as improvements in GMP, SOPs, Forms, and Validation.
Lead and coordinate internal/mock audits, Customer Audits, certification audits, supplier desktop audits, facility verification/validation activities, improvements, etc.
Direct programs or procedures that assure the proper qualification, calibration, operation and maintenance of laboratory equipment, the timely data analysis and reporting of trends, and the completion of written investigations in response to unusual or unexpected results or deviations.
Develop and drive quality plans for new product introductions, test methods, and process inspections, including writing procedures for selecting and applying correct measuring and analytical tools.
Interface with customers to resolve quality concerns and manage the Supplier Quality Management Program with vendors to ensure the quality of purchased parts.
Lead investigations of in-plant quality incidents (foreign material, nonconforming product) and consumer complaints, identifying root causes and facilitating corrective action with plant teams. Interprets and reports consumer complaint data trends and facilitates action plans.
Lead plant internal quality inspections. Create and coordinate schedules and training.
Responsible for US regulatory submissions, certifications, and accreditations, including FDA, EU, and MoCRA standards.
Hire, manage, and retain quality staff by recruiting, selecting, orienting, and training employees.

Required Skills & Experience: (ensure this heading is bold)

Bachelor's degree in chemistry, engineering, or something similar.
10+ years of Quality Management/Regulatory Affairs experience in an FDA-regulated OTC manufacturing environment, preferably skin and personal care products.
5+ years of direct experience developing, leading, and motivating a high-performing team.
Ideal experience includes;
- Proficient in navigating 21 CFR, FTC, EU Regulations (EFSA and ECHA), Prop 65 Listing, and EPA Pesticides Inerts List.
- Certification in Quality (ASQ), Engineering (PE), ISO.

About Versique:

At Versique, we believe people are more than a resume. People invent, propel, unearth, and build. They transform teams, markets, industries, and bottom lines. People do more than fill an open position. They open greater potential. We're here to help fill your human potential and build your human capacity. The Versique brand represents a powerful combination of "versatile" and "unique," hinting at the concept of "search" in its pronunciation.

In 2023, Versique made the Inc. 5000 list of fastest-growing private companies and the Minneapolis-St. Paul Business Journal's Fast 50 list for fastest-growing private companies in Minnesota. Additionally, for the past four years, Versique has been recognized as a Star Tribune Top Workplace and awarded a Best Place to Work in 2022 by the Minneapolis/St. Paul Business Journal, which speaks to the incredible culture we've fostered.

We believe people are the ultimate business advantage. Let's find your people together. And make the best possible.

Versique is an equal opportunity employer committed to creating a diverse workforce. We consider all qualified applicants regardless of race, religion, color, sex, national origin, age, sexual orientation, gender identity, disability, or veteran status.

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