Associate Director of Quality

Associate Director of Quality

The Associate Director of Quality reports to the Vice-President, Quality. The Associate Director oversees evaluations, tracking, trending, and monitoring of the Quality activities in a 503B outsourcing facility. The position provides support in assuring that the drug product has the safety, identity, strength, quality, and purity represented. The candidate should have an excellent understanding of cGMP requirements. The position requires an individual who works independently and in a team environment, experienced in cGMP requirements, quality assurance/control, 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:

• Achieve quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.
• Support the VP Quality in ensuring compliance with regulatory and procedural requirements while providing backup.
• Assist with meeting financial objectives by assisting with estimation requirements; supporting preparation of annual budgets.
• Develop quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories.
• Validate quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures.
• Maintain and improve product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods.
• Oversee Quality Risk Management
• Prepare quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
• Update job knowledge by studying trends in and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
• Enhance department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
• Work with a team to ensure that the systems involved in a 503B outsourcing facility are in a state of control
• Other duties as assigned.

Supervisory Responsibilities:

• Directly hire and lead a team of managers.
• Foster a positive and productive work environment, providing guidance, coaching, and mentoring as needed to achieve a culture of excellence and collaboration.
• Conduct regular 1:1's to address performance, feedback and relationship building.
• Identify training and development needs within the team and…