Over de functie
Responsibilities include the following, while other duties may be assigned.
- Provides expertise and guidance in interpreting agency regulations, guidelines, and internal requirements to ensure site compliance.
- Support new product introduction across FSS by assisting with product evaluations, submitting appropriate CS registration documents and reviewing plant capital projects from a site security standpoint. This work may also include reviewing research protocols and providing oversight to the Process Development groups.
- Implements CSC Standards locally, perform Gap assessment, develop action plan and monitor to completion.
- Responsible for development and execution of site DEA inspection readiness plans. Support sites with managing local DEA district visits and correspondences.
- Manage CS inspections and acts as main point of contact for HA during inspection
- Execute reconciliation of all CS material including the investigation, destruction, and reporting of losses
- Responsible for investigating all CS related deviations (loss in transit, complaints, etc.), identifying corrective actions, assigning owners, and monitoring for completion.
- Ensure CSC training is performed at site for all impacted employees that handle CS.
- Ensure required CS government record keeping and reporting is completed per regulations.
- Leads and manages the work of the Manufacturing Compliance 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.
- Leads group to thoroughly investigate major and complex minor manufacturing deviations. Collaborates cross-functionally to gain alignment on compliance and quality issues. Ensures that deviation investigation meet current quality standards and that risk based decisions are applied.
- Develop and grow a Security culture among the employees and contractors and ensure CS compliance training is performed for all employees. Trainings include developing strong CS coordinators in the following areas: Operations, Warehouse, Shipping & Receiving, QC and Quality.
- Remain current on proposed changes or new regulations that effect operations.
Maak het verschil
You possess the following qualifications, background and abilities:
- A minimum of a Bachelor Degree is required. Advanced degree is preferred.
- A minimum 8 years of related working experience is required.
- A minimum of one year of experience hosting regulatory inspections is required.
- Experience working with popular ERP systems (i.e. SAP, JDE, MAPICS, etc.) is required.
- Experience interpreting compliance requirements and regulations is required.
- Knowledge of DEA and state regulations pertaining to shipping controlled substances preferred.
- General knowledge of the pharmaceutical industry, brand and/or generics is preferred.
- General knowledge of DEA requirements as they relate to distribution and SOM is preferred.
- This position may require up to 10% domestic and international travel including some overnights and weekends.
- 7+ year’s progressive experience in an manufacturing & operations management role at a pharmaceutical manufacturing/distribution facility.
- Previous experience operating under FDA cGMP with a robust understanding of the principles and applications associated with manufacturing operations, maintenance and engineering.
- Previous experience working with auditors, inspectors, and regulatory agencies.
- 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 in designing, managing, and/or operating complex automation processes.
- 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.
- 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 excellent planning and organizational skills, with the ability to balance production and maintenance needs.
- Demonstrates a strong ability to be adaptable and flexible.
- 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.
Wat bieden wij?
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.