Job Information
Amneal Pharmaceuticals Drug Device Combination Product Quality Manager in Bridgewater, New Jersey
Description:
Drug Device Combination Product Manager is a position within the Global Quality Management department.This position is a Corporate Quality function and is a bridge between departments, CMOs and sites respective to Combination Drug Products and Medical Devices. This position performs the function of Independent Reviewer Role, with respect to combination products, with emphasis on Design History Files and Design Control Related Documents. This position is responsible for recognizing and understanding preexisting or potential future unique and potential first-time challenges and offer solutions for intervention with Regulatory non conformances, malfunction or defect related reports and product/device processing failures.This position shall advise of potential emerging trends and issues that may compromise Amneal's compliance standing, customers or reputation. This role provides corporate quality support and leadership with developing and implementing quality compliance program that ensure continued and current conformance to regulatory requirements for all Amneal based combination products throughout the product lifecycle. This role is responsible for supporting new and/existing product projects. This role proactively assesses design control risks through early detection and mitigation, working closely with project leads, site quality, manufacturing, and regulatory functions.This individual is expected to work in a dynamic, high paced and highly interdisciplinary environment to support Drug Device Combination Products. The role will enable efficient communication to management with decision-making responsibilities related to the quality of design control of our combination products.
Essential Functions:
Manage process and establish and maintain timelines for the timely transfer of DHF files for Amneal ANDA/NDA combination products from R&D to Site Quality and/or from external companies to internal Amneal.
Establish dashboards metrics and assess complaint and deviation data for the existence or potential for aberrant conditions that may cause a device to malfunction or have a defect that could, have or has the potential to cause Death or Serious Injury. Supports Pharmacovigilance with the assessment for MDR reporting.
Partner with Cross Functional Departments to create, monitor and execute a risk-based compliance approach throughout the lifecycle of the commercial combination products by leading the establishment of PFMEA and FMEA documents.
Fulfill the independent Reviewer responsibility of Design History File Documents to ensure they are organized, complete, thorough and compliant with regulatory and Amneal requirements completeness and be primary signatory on said documents.
Capable to recognize and understand preexisting or future unique challenges and offer solutions for intervention regulatory considerations associated with combination products, including the integration of drug and device components, as well as considerations for primary packaging and labeling.
Provide support to critical suppliers and Key stakeholders of Device Constituents by reviewing relevant documentation and assess acceptability from a Quality and GMP prospective.
Able to effectively work independently and/or in a leading team member role to get things done. Ability to overcome obstacles, suggest recommendations, lead creative thinking, and be resourceful for troubleshooting and problem solving that pertain to Combination Product and Medical Devices.
Establish product specific electronic folders, organize and input the finalized DHFs documents and ensure they are maintained current by Mfg Sites and/or CMOs after transfer. Accomplished with oversight and monitoring of changes and continued monitoring. Ensure through oversight the performance of Annual reviews of established DHF’s is executed. Provide support as needed.
Define, organize, collect and report data to Quality Management to support the establishment of KPIs and Department Goals. Monitor for existence of adverse trends, signals or pattens that could cause a device malfunction or defect and assess across products and/or device associations.
Partner with Global Product Safety and Pharmacovigilance to assess complaint and AEs for the potential correlation to a device malfunction resulting in the need for MDR reporting. Supports with complaint Investigations as necessary as it relates to Combination Products.
Keep current with ISO and FDA regulations respective to combination products. Train new and existing employees on Combination Product Requirements, processes, and procedures. Maintain the Combination Product Listing and dashboard for new and approved combination products respective to all Amneal sites, CMOs, Partner and third Party relationships. Support Combination Product Related FDA Inspections, as needed
Additional Responsibilities:
Performs other functions as required or assigned.
Help support Combination Product Related FDA Inspections
Complies with all company policies and standards.
