Director of Quality

Seeking a Director of Quality for a direct-hire opportunity in Morton Grove, IL to provide strategic leadership and vision for QC and QA functions, ensuring that all products meet the highest standards of quality, compliance, and safety. The Director will drive the implementation of a robust Quality Management System (QMS) to maintain compliance with FDA, federal, and state regulations for OTC and non-OTC products and national and international regulatory standards.

Essential Duties and Responsibilities:

Strategic Leadership:

• Develop and execute the strategic vision for Quality Control (QC) and Quality Assurance (QA) functions to align with corporate goals.
• Lead and mentor a team of approximately 20 personnel, fostering a culture of excellence, accountability, and continuous improvement.

Quality Oversight:

• Oversee laboratory operations, including microbiology, analytical labs, and quality control processes, ensuring alignment with GMP and FDA standards.
• Make final decisions on product releases, quality deviations, compliance strategies, and QMS structure.

Regulatory Compliance:

• Serve as the primary representative to the FDA and other regulatory bodies during inspections and audits.
• Ensure production and testing sites maintain compliance with cGMP, cGLP, and applicable regulatory requirements.
• Lead CAPA initiatives to address audit findings, ensuring timely and thorough resolution.

Cross-Functional Collaboration:

• Partner with Manufacturing to ensure predictable, high-quality production processes.
• Collaborate with Sales, Marketing, and customers to meet quality expectations and prioritize resources effectively.
• Work with Purchasing and suppliers to ensure consistent quality and address performance issues.

Operational Excellence:

• Drive data-driven decision-making across all quality processes.
• Manage discrepancy reporting and lead investigations, ensuring root causes are identified and resolved.
• Oversee change management programs, including SOPs, throughput, and documentation processes.

Continuous Improvement:

• Lead the development and implementation of quality systems, policies, and procedures to enhance efficiency and compliance.
• Promote the use of statistical methods and Six Sigma principles to analyze data and improve processes.

Customer and Stakeholder Engagement:

• Develop strong relationships with key customers and stakeholders, and other partners.
• Ensure timely and effective communication regarding quality initiatives and compliance issues.

Job Requirements:

Experience:

• Bachelor’s degree in a relevant field. Master’s preferred.
• 10 years of experience in quality assurance and control in personal care, OTC pharmaceuticals, or cosmetics industries.
• Minimum 5 years of experience in a senior management role with demonstrated success leading cross-functional teams.
• Proven experience managing FDA audits, including 483 corrective action plans and driving continuous improvement initiatives.

Technical Skills:

• Proficient in Microsoft Office Suite (Outlook, Word, PowerPoint, Excel).
• Strong knowledge of U.S. and international OTC and cosmetics regulations.
• Expertise in statistical analysis and process improvement methodologies (e.g., Six Sigma).

Leadership and Soft Skills:

• Demonstrated ability to lead, mentor, and inspire teams.
• Excellent communication skills, both written and verbal, with the ability to influence stakeholders at all levels.
• Strategic thinker with a proactive, solutions-focused mindset.
• Strong customer service orientation and ability to manage client relationships effectively.

Behavioral Attributes:

• Data-Driven Decision Maker: Leverages analytics to guide strategic and operational decisions.
• Self-Starter: Takes initiative and demonstrates a proactive approach to problem-solving and innovation.
• Adaptable Leader: Thrives in a dynamic, fast-paced environment with evolving priorities.
• Collaborative: Works effectively across teams, fostering a positive and productive work environment.
• Ethical and Accountable: Models integrity and high ethical standards in all interactions and decisions.
• Continuous Improvement Champion: Identifies opportunities to enhance systems, processes, and performance.

Job Type: Full-time

Pay: $140,000.00 - $170,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• No nights

Ability to Commute:

• Morton Grove, IL 60053 (Required)

Work Location: In person

Salary : $140,000 - $170,000