Job Description
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.
Qualifications
Education:
- Bachelors Degree (BA/BS) In a relevant field such as Pharmacy, Biomedical Engineering, Chemistry, Biology, or a related scientific discipline is required. - Required
- Master Degree (MS/MA) In a relevant field is a benefit but not required. - Preferred
Experience:
- 3 years or more in Experience specifically with drug-device combination products or medical devices.
- 3 years or more in Demonstrated experience in creation or review of design history file documents, conducting risk assessments, and participating in FDA inspections.
- 2 years or more in Experience in a Quality functional area, i.e. Quality Systems, Quality Management etc. CMC regulatory affairs, or a related field within the pharmaceutical or medical device industry.
- 1 year or more in In a direct managerial role,
- 1 year or more in Experience in educating employees on policies and procedures is desirable
Skills:
- Strong understanding of quality management principles and regulatory requirements relevant to drug-device combination products, including FDA regulations (21 CFR Part 4, 21 CFR Part 820) and international standards (ISO 13485, ISO 14971). - Advanced
- Excellent organizational skills with the ability to efficiently manage and organize documentation related to combination products, including design history files and product-specific folders. - Advanced
- Effective communication skills to facilitate collaboration and decision-making among interdisciplinary teams, including project leads, quality assurance, manufacturing, and regulatory functions. - Advanced
- Proficiency in conducting risk assessments for process and product changes, as well as experience in participating in complaint investigations related to combination products. - Advanced
- Ability to collect and analyze combination product key performance indicators (KPI) data to identify trends and areas for improvement. - Advanced
- Familiarity with FDA inspection processes and the ability to support combination product-related inspections effectively. - Advanced
Specialized Knowledge:
- In-depth knowledge of drug-device combination product development and lifecycle management processes, including design controls, risk management, and post-market surveillance.
- Understanding of the unique challenges and regulatory considerations associated with combination products, including the integration of drug and device components, as well as considerations for primary packaging and labeling.
Licenses:
- Certification in Quality Management (e.g., Certified Quality Auditor, Certified Quality Engineer) may be beneficial.-1 1/2 Yrs-Preferred
- Specific certifications related to drug-device combination products or regulatory affairs (e.g., Regulatory Affairs Certification) could be advantageous.-1 1/2 Yrs-Preferred