<p>Job Title: Quality Director</p> <p>Job Description</p> <p>The Manufacturing Director of Quality is responsible for leading and implementing quality assurance and control strategies across all manufacturing operations. This role ensures compliance with regulatory requirements, industry standards, and company policies while driving continuous improvement initiatives. The Director will oversee quality management systems (QMS), collaborate with cross-functional teams, and develop a culture of quality excellence.</p> <p>Responsibilities</p> <ul> <li>Develop, implement, and maintain a robust Quality Management System (QMS) in compliance with GMP, FDA, or other relevant industry standards. </li><li>Ensure all manufacturing processes meet regulatory and customer quality requirements. </li><li>Lead internal and external audits, manage non-conformances, and drive corrective/preventive actions (CAPAs). </li><li>Maintain documentation and records in compliance with regulatory agencies. </li><li>Identify and implement process improvements to enhance product quality and reduce defects. </li><li>Utilize Six Sigma, Lean, and other methodologies to drive operational excellence. </li><li>Collaborate with manufacturing, engineering, and supply chain teams to improve quality performance. </li><li>Analyze quality metrics and KPIs to identify trends and recommend strategic initiatives. </li><li>Lead and mentor the quality assurance and quality control teams, ensuring alignment with business objectives. </li><li>Develop training programs to enhance quality awareness across the organization. </li><li>Foster a culture of continuous improvement and accountability for quality at all levels. </li><li>Lead root cause analysis (RCA) and failure investigations for quality incidents. </li><li>Develop risk mitigation strategies to prevent quality issues from recurring. </li><li>Ensure product traceability and compliance with safety and regulatory requirements. </li></ul> <p>Essential Skills</p> <ul> <li>BS Degree in Science, Quality Management, or a related field (Master's degree is a plus). </li><li>10+ years of experience in manufacturing quality. </li><li>5 years in a leadership role. </li><li>Strong knowledge of GMP and FDA quality standards within OTC Pharma. </li><li>Experience with Six Sigma, Lean Manufacturing, or other process improvement methodologies. </li><li>Proficiency in quality tools such as QCBD, FMEA, SPC, PPAP, APQP, and RCA. </li><li>Excellent leadership, communication, and problem-solving skills. </li><li>Ability to work in a fast-paced environment and manage multiple priorities. </li></ul> <p>Additional Skills & Qualifications</p> <ul> <li>Experience in the OTC pharmaceutical industry. </li><li>Strong understanding of quality assurance processes. </li><li>Ability to develop and implement quality training programs. </li><li>Experience in leading and mentoring quality teams. </li></ul> <p>Work Environment</p> <p>The role involves working in all areas of the facility, including both office and manufacturing environments. The work environment is dynamic and fast-paced, requiring effective management of multiple priorities.</p> <p>Pay and Benefits</p> <p>The pay range for this position is $140000.00 - $200000.00/yr.</p> <p>Equal to employee's yearly gross salary, rounded to nearest thousand</p> <p>Short-Term Disability Insurance, 100% Paid by company</p> <p>Wait: 7 days for hospitalization or illness</p> <p>13 weeks maximum; 60% weekly wages or $1,500 max per week</p> <p>Long-Term Disability Insurance, 100% Paid by company (Exempt Employees Only)</p> <p>Workplace Type</p> <p>This is a fully onsite position in Milwaukee,WI.</p> <p>Application Deadline</p> <p>This position is anticipated to close on Mar 28, 2025.</p> <p>About Actalent</p> <p>Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.</p> <p>Diversity, Equity & Inclusion</p> <p>At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:</p> <ul> <li>Hiring diverse talent </li><li>Maintaining an inclusive environment through persistent self-reflection </li><li>Building a culture of care, engagement, and recognition with clear outcomes </li><li>Ensuring growth opportunities for our people </li></ul> <p>The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.</p> <p>If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.</p>