Über die Tätigkeit

The Pharmacy Operations Group is responsible for cGMP manufacturing activities (including dispensing, compounding, and aseptic filling), post-production (including visual inspection, and labeling), and order fulfillment (picking, packaging, and shipping) in a DEA, FDA and State Board of Pharmacy compliance environment. The Director of Pharmacy Operations position is responsible for providing key leadership, direction, organization, management, monitoring and compliance of the roles, activities and proceedings to ensure safe, cost effective, and timely processing of client products. This position is responsible for all of cGMP Manufacturing and Pharmacy Operations.

 

In this role, you will have leadership responsibilities for all DEA and State agency inspections. You will be the main Fagron contact with DEA regional and national offices for escalating issues relating to import/export permits, and certificates of registration.

Responsibilities include the following, while other duties may be assigned.

  • Leads all areas of cGMP Manufacturing and Pharmacy activities so that products are manufactured on-schedule and within quality standards and cost objectives.
  • Hires, trains, motivates, leads, develops and evaluates staff. Takes corrective action as necessary on a timely basis and in accordance with company policy. Ensures compliance with current federal, state and local regulations; consulting with Human Resources as appropriate.
  • Develops the operations plan and establishes procedures for maintaining high standards of manufacturing operations to ensure that products conform to established quality, compliance and delivery standards of various regulatory (FDA, DEA), State Board, & customer agencies.
  • Assists SLT in the development and formulation of long and short-range strategy, planning, policies, programs and objectives related to cGMP Operations.
  • Achieves optimum employee levels with the least amount of overhead and raw material costs to meet financial standard planning.
  • Provides expertise and guidance in interpreting agency regulations, guidelines, and internal requirements to ensure site compliance.
  • Support new product development and introduction by assisting with product evaluations & proposals, submitting appropriate registration documents and reviewing plant capital projects.
  • Manage Controlled Substance inspections and main point of contact during inspections.
  • Responsible for investigating all CS related deviations (loss in transit, complaints, etc.), identifying corrective actions, assigning owners, and monitoring for completion.
  • Leads and manages the work of the group to meet quality, productivity and efficiency goals and to achieve operation and quality goals and objectives. Accountable for effectively leading, driving and managing change in Manufacturing Compliance in a rapidly growing, highly dynamic environment.

 

Ihr Profil

Qualifications

  • A minimum of a Bachelor Degree is required. Advanced degree is preferred.
  • 8+ year’s progressive experience in a manufacturing & operations management role at a pharmaceutical manufacturing or distribution facility.
  • A minimum of three years of experience hosting & supporting regulatory inspections.
  • Experience working with popular ERP systems (i.e. SAP, JDE, MAPICS, etc.) is required.
  • Experience interpreting compliance requirements and regulations is required.

Profile/Experiences:

  • Previous experience operating under FDA cGMP with a robust understanding of the principles and applications associated with manufacturing operations, maintenance and engineering.
  • Previous experience/best practices implementing and using continuous improvement/lean tools such as; Six Sigma, 5-S, Lean Manufacturing, Transactional Lean, etc. to drive improvement.
  • Previous experience/broad understanding of safety systems and safety regulations, and enforcement of safety rules and policies.
  • Demonstrates proven knowledge of business and management principles; ability to establish and develop key performance indicators, financial standards, and SMART objectives to demonstrate how effectively operations is achieving key business objectives.
  • Demonstrates strong leadership, motivation, teambuilding, communication, and advanced coaching skills that instill a strong sense of mission in a team environment across all levels of organization.
  • Demonstrates skills to solve complex problems in a wide variety of high-pressure situations which require a high degree of ingenuity, creativity and innovativeness. In situations where precedent may not exist, is able to independently exercise judgment, determine appropriate solution and take action.
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