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Job Summary:

The Quality Systems & Compliance Manager will lead our quality assurance initiatives and ensure compliance with our manufacturing operations. This strategic leadership role combines technical expertise with team management responsibilities, focusing on developing and maintaining robust quality management systems for cosmetics and OTC drug products in a highly regulated environment. The successful candidate will spearhead risk management strategies, drive continuous improvement initiatives, and ensure full compliance with FDA regulations, GMP standards, and ISO requirements. This position requires a hands-on leader who can manage complex cross-functional projects while building and mentoring a high-performing quality team.

Essential Duties and Responsibilities:

+ Develop, implement, and maintain, along with your team, risk management strategies within Quality Management Systems (QMS) tailored to the needs of the business, including deviations, complaints, change control, CAPA, APQR, Out-of-Specifications, training, document control and internal audit program.

+ Ensure compliance with GMP, FDA regulations (21 CFR Parts 210/211), and ISO 22716 for cosmetics and OTC drug products.

+ Aid in root cause analyses and corrective/preventive action (CAPA) initiatives associated with investigations of quality issues, including product non-conformance, consumer complaints, and manufacturing deviations.

+ Aid in review and approval of quality investigation reports, change control projects, document changes, CAPA and APQR reports.

+ Design, implement, and maintain comprehensive quality management systems (QMS) in accordance with FDA regulations (21 CFR), ISO standards, and Good Manufacturing Practices (GMP)

+ Lead large cross functional and complex initiatives to identify, develop, modify, improve, and implement global process solutions for compliant Quality Systems and continuous improvement initiatives. Collaborate with cross-functional teams to support continuous improvement initiatives.

+ Develop, Review, Write, and Implement SOP's for quality functions and ensure compliance with all regulatory and GMP requirements.

+ Drive collection, analysis and trending of QC data and Quality metrics

+ Drives internal audit program, as well as regulatory and customer audit inspection readiness.

+ Provides training and mentoring for employee development.

+ Demonstrated leadership and management skills, including establishing direction and goals, and building good work ethics for the team. Reviews subordinate performance in a formal review process.

+ Train and mentor cross-functional teams on quality standards and best practices.

Qualifications:

+ Minimum 7 years of experience in a QA or regulated manufacturing environment preferred (cosmetics or OTC drugs a plus).

+ Bachelor’s degree in a scientific or technical field (e.g., Chemistry, Biology, Pharmaceutical Sciences).

Preferred Skills:

+ ASQ Certified Quality Engineer (CQE), ASQ Certified Quality Auditor (CQA), ISO 13485 Lead Auditor Certification.

+ Expertise in managing compliance remediation programs within FDA regulated industry.

+ Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/ 210/ 211), including data integrity and practices.

+ Experience working with cross-functional technology teams and enterprise systems.

+ Exceptional problem-solving skills, attention to detail, and the ability to manage multiple priorities in a fast-paced environment.

+ Working knowledge of Six Sigma and/or Lean Manufacturing principles.

+ Proficiency in quality tools and methodologies, including Failure Modes and Effects Analysis (FMEA), 8D Problem Solving, Root Cause Analysis, Corrective and Preventive Actions (CAPA), Mistake Proofing and Process Control.

+ Strong attention to detail and organizational skills.

+ Effective written and verbal communication skills.

+ Proficiency in Microsoft Office and familiarity with electronic quality systems.

Physical Requirements:

+ Ability to lift and move objects weighing up to 25 pounds regularly and occasionally heavier items with assistance.

+ Ability to stand, walk, bend, stoop, push, and pull for extended periods during shifts.

+ Good understanding of safety protocols and practices.

+ Willingness to work flexible hours, including shifts and weekends.

+ Ability to work in a fast-paced environment and adapt to changing priorities.

Salary Range:

At Prime, we believe that a diverse, equitable and inclusive workplace makes us a more relevant, more competitive, and more resilient company. We welcome people from all backgrounds, ethnicities, cultures, and experiences. Prime is an equal opportunity employer.

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