Director of Sterile Products

1 day ago


Morristown, Tennessee, United States Alvogen Full time
Job Title: Director Quality-Steriles

Job Summary:

The Director, Quality-Steriles is responsible for ensuring the quality and compliance of Sterile/Combo Products and Medical Devices at Alvogen. This role requires a strong understanding of regulatory requirements, including cGMPs, FDA, USP, ISO, and ICH guidelines. The Director will lead a team of Quality Managers who work with Contract Manufacturers and partners to ensure compliance with Alvogen's Quality Management System.

Key Responsibilities:

  • Leadership: Provide guidance and supervision to a team of Quality Managers.
  • Third-Party Support: Ensure all injectable/combination products manufactured for or on behalf of Alvogen by third-party suppliers are manufactured, packaged, and tested in compliance with cGMPs, approved ANDA/NDA, and applicable regulatory requirements.
  • Compliance: Implement, maintain, and ensure adherence to the Alvogen QMS, assure all third-party partners are in compliance with all appropriate regulations, and ensure that all third-party partner sterile/combination products meet requirements.
  • Interdepartmental Support: Partner with Supply Chain, R&D, and other departments to support the development and launch of US products from CMOs and internal Alvogen sites.

Qualifications:

  • BS in Pharmacy, Chemistry, Microbiology, or Biology with a minimum of 15 years' experience in the Pharmaceutical Industry, preferably in an ISO 13485 certified organization.
  • Extensive Quality experience with injectable/combination products is required.
  • Expert knowledge of cGMPs, and strong understanding of FDA, USP, ISO, and ICH guidelines.
  • Excellent leadership skills in all areas of communication, influencing, collaboration, and decision-making.

Physical Demand Factors:

  • While performing the duties of this job, the Director Quality-Steriles is required to sit and work at a computer for extended periods of time.
  • Regularly required to talk, listen, and attend meetings/teleconference calls.
  • Approximately 25-30% business travel required to external Contract Manufacturing Organization (CMO)/Business Partner sites, to attend professional development training seminars, or otherwise as directed by the Sr. Director of Third-Party QA.

GMP Decision-Making Authority:

The position has the GMP decision-making authority regarding the disposition of batches. Through the Quality team, and as required, approves all standards, specifications, master batch records, procedures, validation protocols and reports, change controls, batch records, deviations, and release of acceptable products.



  • Morristown, Tennessee, United States TEPHRA Full time

    About the RoleWe are seeking a seasoned product marketing leader to join our team at TEPHRA. As a key member of our marketing organization, you will be responsible for developing and executing product marketing strategies that drive business growth and customer engagement.Key ResponsibilitiesPlan, manage, and execute product marketing initiatives to drive...


  • Morristown, Tennessee, United States Atlantic Health System Full time

    Job SummaryWe are seeking a highly skilled and detail-oriented Pharmacy Technician II to join our team at Atlantic Health System. As a Pharmacy Technician II, you will play a critical role in supporting our pharmacy operations and ensuring the highest level of patient care.Key ResponsibilitiesFilling Orders: Accurately and promptly fill orders for...


  • Morristown, Tennessee, United States Colas USA Full time

    Director of Equipment Role at Colas USAIn the capacity of Director of Equipment at Colas USA, you will play a pivotal role in enhancing and streamlining equipment performance throughout the organization. Your primary objective will be to boost machinery and workshop productivity, enforce safety protocols, and devise comprehensive strategies for effective...


  • Morristown, Tennessee, United States Colas USA Full time

    Director of Equipment Position at Colas USAIn the role of Director of Equipment at Colas USA, you will take charge of enhancing and aligning equipment functionality throughout the organization. Your primary objective will be to boost equipment and workshop productivity, enforce safety protocols, and devise long-term plans for effective equipment...


  • Morristown, Tennessee, United States Colas USA Full time

    Director of Equipment Role at Colas USAIn the capacity of Director of Equipment at Colas USA, you will take charge of optimizing and enhancing the operational effectiveness of equipment throughout the organization. Your primary objective will be to improve equipment and workshop productivity, enforce safety protocols, and devise long-term plans for equipment...


  • Morristown, Tennessee, United States Search Masters, Inc Full time

    Job Title: Director of EngineeringJob SummaryWe are seeking a highly experienced Director of Engineering to lead our manufacturing and process engineering team. As a key member of our leadership team, you will be responsible for directing and leading the team to achieve business objectives.Key ResponsibilitiesLead and manage a team of process and...

  • Operations Director

    3 weeks ago


    Morristown, Tennessee, United States Jobot Full time

    Job Summary:We are seeking an experienced Operations Director to lead our manufacturing facility in Morristown, TN. As a key member of our team, you will be responsible for providing overall leadership and direction to plant operations, ensuring the successful execution of our manufacturing vision and goals.Key Responsibilities:Leadership and Direction:...

  • Operations Director

    4 weeks ago


    Morristown, Tennessee, United States ProActivate Full time

    **Job Summary**ProActivate is seeking an experienced Operations Director to lead our Distribution, Delivery, and Facility Operations teams. As a key member of our leadership team, you will be responsible for driving business growth and excellence through effective management of our operations.**Key Responsibilities:**Oversee the management of our...

  • Operations Director

    3 weeks ago


    Morristown, Tennessee, United States ProActivate Full time

    **Job Summary**ProActivate is seeking an experienced Operations Director to lead our Distribution, Delivery, and Facility Operations teams. As a key member of our leadership team, you will be responsible for ensuring the success of our operations and driving business growth.**Key Responsibilities:**Manage Distribution Center, Delivery, and Facilities...


  • Morristown, Tennessee, United States Lonza Full time

    Job Title: Associate Director, Business Development US EastLonza is a global leader in life sciences, operating across three continents. We're seeking an experienced Associate Director to drive sales growth and new business acquisition in the US East region.Key Responsibilities:Develop and implement sales strategies to align with Lonza's strategic priorities...


  • Morristown, Tennessee, United States LHC Group Full time

    **About the Role**We are seeking a highly skilled Business Development Director to join our team at LHC Group. As a key member of our sales team, you will be responsible for executing our sales strategy to increase market share through account development and educating the medical community on our services.**Key Responsibilities**Build and maintain...


  • Morristown, Tennessee, United States Atlantic Health System Full time

    Job Title: Supervisor Central Supply SvcsAtlantic Health System is seeking a Full-Time Supervisor for the Central Sterile Processing Department at Morristown Medical Center. The successful candidate will be responsible for planning, organizing, and implementing quality initiatives within the sterile processing environment and departments with sterile...


  • Morristown, Tennessee, United States Intercept Pharmaceuticals Full time

    Job OverviewPOSITION SUMMARY:Intercept Pharmaceuticals is seeking a highly skilled Director of Publications Planning to enhance our leadership in the field of rare and serious liver diseases. This pivotal role involves the formulation and implementation of extensive publication strategies across various Intercept initiatives, collaborating closely with...


  • Morristown, Tennessee, United States Atlantic Health System Full time

    Job SummaryWe are seeking a highly skilled Pharmacy Technician II to join our team at Atlantic Health System. As a Pharmacy Technician II, you will play a critical role in supporting our pharmacists and ensuring the efficient operation of our pharmacy services.Key ResponsibilitiesFilling Orders: Accurately and promptly fill orders for pharmacists to check...

  • Operations Director

    3 weeks ago


    Morristown, Tennessee, United States Green Works Full time

    {"title": "Operations Manager", "description": "Job SummaryGreen Works is seeking an experienced Operations Manager to oversee the daily operations of our vehicle assembly production line in Morristown. As a key member of our team, you will be responsible for ensuring production goals are met efficiently, safely, and within budget.Key ResponsibilitiesSafety:...

  • Operations Director

    4 weeks ago


    Morristown, Tennessee, United States ProActivate Full time

    **Job Summary:**ProActivate is seeking an experienced Operations Manager to oversee the Distribution Center, Delivery, and Facilities operations. This role is responsible for ensuring Associate Success through Safety, Quality, and Productivity, while promoting Company Culture throughout the workforce.**Key Responsibilities:**Oversee budgeting, reporting, and...


  • Morristown, Tennessee, United States Soloh Partners Inc Full time

    Job Title: Interventional Radiology TechnicianAt Soloh Partners Inc, we are seeking a skilled Interventional Radiology Technician to join our team.Job SummaryWe are looking for a highly motivated and experienced Interventional Radiology Technician to assist proceduralists during complex diagnostic and interventional vascular, neuro-interventional...


  • Morristown, Tennessee, United States Soloh Partners Inc Full time

    Job Title: Interventional Radiology TechnicianAt Soloh Partners Inc, we are seeking a skilled Interventional Radiology Technician to join our team.Job SummaryWe are looking for a highly motivated and experienced Interventional Radiology Technician to assist proceduralists during complex diagnostic and interventional vascular, neuro-interventional cases. The...


  • Morristown, Tennessee, United States Soloh Partners Inc Full time

    Job SummaryWe are seeking a highly skilled Interventional Radiology Technician to join our team at Soloh Partners Inc. As an Interventional Radiology Technician, you will play a critical role in assisting proceduralists during complex diagnostic and interventional vascular, neuro-interventional cases.Key ResponsibilitiesAssist proceduralists during complex...


  • Morristown, Tennessee, United States My New Company Full time

    Job Title: Interventional Radiology TechMy New Company is seeking a skilled Interventional Radiology Tech to join our team. As an Interventional Radiology Tech, you will play a critical role in assisting proceduralists during complex diagnostic and interventional vascular, neuro-interventional cases.Key Responsibilities:Assist proceduralists during complex...