Quality Systems Manager

Quality Systems Manager

This description is intended to be illustrative of the major duties performed by the employee assigned to this position. Performs other duties as assigned.

This position will report to the Director of QA. The Quality Systems Manager is responsible for overseeing the quality systems within the Quality Assurance Department. This role is critical in ensuring our quality management systems meet regulatory requirements and industry standards, maintaining the highest levels of product quality and safety. The Quality Systems Manager will have responsibility for change controls, deviations, CAPA, metrics, and quality improvements. The position requires an individual who works independently and in a team environment, experienced in cGMP requirements, attention to detail, and excellent communication with other functional areas and sites.

Why Join Leiters Health?

Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further - Leiters Health is seeking talented individuals like you to join our dynamic team!

At Leiters Health, we're not just another pharmaceutical company - we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do.

• Innovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement.
• Meaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positively impact patients' lives.
• Professional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry.
• Cutting-Edge Technology: Work with state-of-the-art facilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing.
• Collaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration.

Who We're Looking For:

We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today!

Essential Functions:

• Oversee Quality systems: change controls, deviations, and CAPA
• Ensure all processes and documentation adhere to cGMP and other relevant regulatory standards
• Identify potential quality risks and implement mitigation strategies. Conduct risk assessments
• Lead continuous improvement initiatives to enhance quality systems, processes, and procedures
• Work closely with other departments, including production, R&D, supply chain, and QC to ensure quality standards are met throughout the product lifecycle
• Analyze quality data to identify trends, root causes, and areas of opportunity for improvement.
• Other duties as assigned.

Supervisory Responsibilities:

• Lead and manage a team of Quality Engineers, providing direction, support, and development opportunities.
• Conduct regular performance reviews, provide constructive feedback, and implement performance improvement plans as needed.
• Provide a positive and collaborative work environment, addressing and resolving conflict promptly and fairly.

Experience and Necessary Skills:

• Knowledge and experience with US FDA cGMP, preferably in a commercial compounding outsourcing facility
• Knowledge of compounding techniques and controlled environments
• Knowledge of appropriate materials and conditions
• Able to identify potential adverse issues
• Excellent organization and documentation skills
• Detail oriented
• Computer skills, including Microsoft Word and Excel
• Minimum of a BS or BA degree in a scientific discipline required
• Minimum of 5 years of experiencing working in an FDA-regulated environment
• Able to lift up to 20 lbs and stand for up to two hours when required

Benefits:

• 100% employer paid medical plan.
• Dental & Vision insurance options including FSA & HSA
• Employer Paid Life Insurance & Employee Assistance Program
• Short Term & Long-Term Disability Insurance
• Up to 4% 401K Matching (100% vested on day one!)
• Generous Paid Time Off Options - vacation, sick, paid leave and holidays!
• $5,250 Annual Tuition Reimbursement after 6 months
• $1,000 Referral Bonus Program with no limit
• Eligible for annual bonus program

Timeline: We will be accepting applications on an ongoing basis until position is filled.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

*Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.