Senior Director of Quality Management

3 days ago

Englewood, Colorado, United States Leiters Inc Full time
Job Description

Leiters Health is seeking a highly skilled Senior Director of Quality to oversee all site-specific Quality activities and compliance with cGMP requirements in a 503B outsourcing facility.

Key Responsibilities:

  • Lead and manage employees responsible for all quality activities in a 503B facility.
  • Develop and maintain an appropriate staffing model to ensure the quality unit is adequately staffed to meet business demands.
  • Main point of contact for regulatory audits associated with FDA, Board of Pharmacy, and customer audits.
  • Achieve quality operational objectives by contributing information and analysis to strategic plans and reviews.
  • Meet quality financial objectives by estimating requirements, preparing an annual budget, and analyzing variances.
  • Develop quality plans by conducting hazard analyses, identifying critical control points, and establishing preventive measures.
  • Validate quality processes by establishing product specifications and quality attributes, measuring production, and documenting evidence.
  • Maintain and improve product quality by completing product, company, system, compliance, and surveillance audits.
  • Prepare quality documentation and reports by collecting, analyzing, and summarizing information and trends.
  • Interact effectively with Executive Leadership Team and contribute to the continued growth and success of the Company.

Requirements:

  • Minimum of 7 years of experience working in an FDA-regulated environment, with a minimum of 5 years of management experience.
  • Strategic and analytical thinker with the ability to examine details and interpret the impact of key business drivers or potential adverse issues.
  • Demonstrated knowledge and experience with US FDA cGMP, preferably in a commercial compounding outsourcing facility.
  • Superior problem-solving and decision-making skills.
  • Team player with the ability to build relationships and work collaboratively across lines of senior leadership and other team members.
  • Knowledge of compounding techniques, controlled environments, and appropriate materials and conditions.
  • Highest level of integrity and good judgment, with the ability to effectively deal with highly sensitive, confidential information.
  • Demonstrated commitment to sound business ethics and corporate responsibility.
  • Excellent organization, oral and written communication, and documentation skills.
  • Detail-oriented.
  • BS or BA degree required (in a scientific discipline desired).
  • Experience in a cGMP environment in manufacturing/laboratories with a preference for sterile compounding.
  • Computer skills, including Microsoft Word and Excel.
  • 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.

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