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Iroko Pharmaceuticals, LLC
 Navy Yard Corporate Center
One Crescent Drive
Suite 400
Philadelphia, PA  19112
p  267.546.3003
f   267.546.3004
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 		If you are interested in improving the quality of life for people around the globe and want to work in a dynamic, fast-paced environment where you can make a difference, please consider our posted job opportunities.

Iroko is an equal opportunity employer and encourages qualified applicants to apply regardless of race, color, religion, sex, sexual orientation, age, national origin, disability or veteran status.

Available Positions
  • Senior External Quality Assurance Manager
  • Senior Planner/Buyer


    Position Title SENIOR EXTERNAL QUALITY ASSURANCE MANAGER
    Requisition Number 0001
    Job Description Reports to: Director External Quality Assurance

    This position functions as the Site QA manager for external manufacturing partners. Individual is responsible to directly manage both domestic and international strategic compliance imperative and directives with regard to the external sites and products. Assist QA Director in developing, maintaining and implementing Internal Quality Systems, including but not limited to complaints, investigations, document control, change control, review and approval of GMP documentation, auditing and product release. Perform global auditing of CMOs, CROs and API sites. Interact with external partners on a daily basis providing support as needed to achieve goals toward project completion. Ongoing Quality Assurance support of product line with global external partners. Responsible for negotiating/composing Quality Agreements as required.
    Responsibilities
    • Responsible for Quality department during absence of Director Quality Assurance
    • Support Internal and External Quality Functions
    • Develop Quality Systems and Procedures as required
      1. Develop and Maintain Audit Schedule
      2. Schedule and Perform Audits as lead auditor
      3. Preparation, and compose audit reports
      4. Assure corrective actions are complete on time at CMO's
      5. Negotiate and approve Quality Agreements
      6. Maintain Approved Vendor/Supplier list
      7. Review and approve GMP documentation, i.e., batch records, specifications, protocols validation reports, stability data, labeling, CMC data for regulatory filing, method transfer data, OOS investigations
      8. Perform trend analysis as requested
      9. Develop and maintain Quality Dashboard
      10. Evaluate product complaints and develop corrective actions with CMO's
      11. Coordinate/Complete Annual Product Reviews
      12. Evaluate annual product review data
      13. Conduct Investigations/review external investigations and deviations
      14. Release commercial/clinical material
      15. Assist in FDA/health agency inspections
      16. Assist in recalls
      17. Review and Approve Change control
      18. Support Document Control as needed
      19. Compose SOPs as appropriate
      20. Perform training as appropriate
      21. Review and approve GMP documentation as requested
      22. Perform risk assessments as needed
    Requirements
    • BS in Scientific discipline - Biology, Chemistry, Pharmacy or Chem. Eng.
    • Minimum 10 years experience in a variety of Quality positions which include Quality Systems development and management, CMO and API Auditing experience in a variety of manufacturing environments, contract site management, document control, process and product validation, Analytical Biological Analysis
    • Experience with a variety of pharmaceutical dosage forms include solid orals, semi-solids, liquids, transdermals and sterile products
    • Familiar with US/ EU/JP GMP regulations and ICH guidelines
    • Flexibility
    • Excellent communication and interpersonal skills
    • Ability to translate and communicate technical outcomes into business objectives
    • Must be able to travel a minimum of 20%
    Background Check(s) Required No
    Employee Type Full Time
    Department Name Operations
    Position Location Navy Yard Corporate Center, One Crescent Drive, Suite 400
    Philadelphia, PA 19112
    To Apply For This Position
    1. Download and complete Employment Application.

      Download Employment Application.

    2. Click "APPLY FOR THIS POSITION" (below). Attach your application, cover letter and resume and send.

      APPLY FOR THIS POSITION



    Position Title SENIOR PLANNER/BUYER
    Requisition Number 0002
    Job Description
    1. Production planning for assigned Pharmaceutical products and contract sites; ownership to drive the S&OP meetings with Marketing and Finance. Responsible for development and attainment of FG & RM delivery schedules.
    2. Maintain relationships with External Site Management and Quality Assurance on product or site issues, negotiating schedules for mutual benefit.
    3. Develop and coordinate supply plans with assigned contract sites across the Iroko International Supply Chain. These plans include: Material Suppliers, Manufacturing and Packaging Sites, 3PL warehousing and shipping networks. Many of these sites are ex-US and require ability to work with multiple cultures and partners where English is a non-primary language.
    4. Manage the MRP process for assigned brands and effectively perform data analysis to support customer needs (i.e. develop Production Forecasts for suppliers, place Purchase Orders, track and resolve supply issues).
    5. Inventory Management: responsible for meeting established targets for inventory levels and delivery of related information for inventory reporting.
    6. Inventory Information System(s): Develop and maintain planning excel workbooks and establish planning parameters, system set up, monitoring, maintenance and accuracy. Team member supporting implementation and maintenance of ERP Systems.
    7. Purchasing: Ensure purchasing process and systems are accurately maintained and monitored to insure prompt supplier payments, orders are placed within lead times for suppliers and forecasts are submitted in compliance with partner agreements.
    8. Successful integrator and coordination with other internal functions including: Logistics, QA, External Operations, Finance, Project Planning, Regulatory and Marketing.
    9. Participate in and lead projects as assigned, facilitating and participating in meetings as required.
    10. Actively identify opportunities to streamline processes and reduce non-value added activities.
    Responsibilities
    1. Planning/Purchasing and Logistics support for assigned brands. Accumulate, aggregate and interpret data across production, warehousing and distribution sites within the Global Supply Chain.
    		 70%
    1. Lead S&OP meetings with external partners and internal support groups to achieve inventory goals for each product.
    		 15%
    1. Provide support of assigned projects as needed on assigned teams and projects.
    		 10%
    1. Provide planning systems support/improvements
    		 25%
    Innovation/Creativity Innovation and creativity are key in ensuring continuity of supply for existing products and for the launch of new products, and for the continuous improvement of the Iroko Supply Chain process. Examples of situations/activities that demand a high level of creativity are:
    • Managing product and information flow between multiple sites and partners in countries across the globe
    • Managing partner/supplier relationships, many of which will be with individuals who do not have a strong command of English
    • Meeting commitments
    • Developing and executing product supply transfers within committed time.
    COmpetency Requirements
    • INTERDEPENDENT PARTNERING
    • MASTERS COMPLEXITY
    • ANALITICAL SKILLS
    • KNOWLEDGE OF STATISTICS
    • ABILITY TO INFLUENCE W/O DIRECT RESPONSIBILITY
    • APICS CERTIFIED PREFERRED
    • ABILITY TO TRAVEL
    • CUSTOMER/MARKETPLACE FOCUS
    • MID TO ADVANCED USER OF EXCEL, ACCESS, POWER POINT, VISIO
    • EXCELLENT INTERPERSONAL SKILLS
    • ADDITIONAL LANGUAGES (OPTIONAL)
    Physical Requirements/
    Working Conditions    		 Working condition is an office environment with 15% travel. Travel to Supplier and other manufacturing sites as needed and can range from one day to as long as one week per trip.
    Minimum Experience Required 6 to 8 years
    Education BA/BS required: Supply Chain, Logistics, Business, or Operations.
    MA/MS/MBA preferred: Business or Operations.
    Background Check(s) Required No
    Employee Type Temporary, Hourly Paid
    Department Name Operations
    Position Location Navy Yard Corporate Center, One Crescent Drive, Suite 400
    Philadelphia, PA 19112
    To Apply For This Position
    1. Download and complete Employment Application.

      Download Employment Application.

    2. Click "APPLY FOR THIS POSITION" (below). Attach your application, cover letter and resume and send.

      APPLY FOR THIS POSITION



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