Director, Post Market and Commercial Quality

Full Time
Parsippany, NJ 07054
Posted Today
Job description
There may be an option to work in a hybrid schedule, based on business needs.
Summary
The incumbent provides strategic and operational leadership to the global Post Market and Commercial Quality organization by continuously improving products through investigation of complaints, corrective actions, and sharing learnings with new product development programs.
The incumbent ensures global quality system requirements are implemented at ADC local legal entities and distributors.
The incumbent leads and guides Global Customer Support across all countries and regions worldwide, including distributors, on products and processes for post market quality compliance.
This includes resolution of customer complaints through investigation, failure analysis and corrective action and guidance/leadership regarding stop shipments and field corrective actions to ensure proper implementation.
Responsible for Medical device vigilance for Ascensia Diabetes Care products worldwide, including oversight of the analysis, review, decision-making process and communication of Adverse Events, Incidents and Field Safety Corrective Actions/Recall notifications to the local health authorities in liaison with local/regional functions where applicable, ensuring compliance with applicable laws, directives and regulations.
Oversee Internal Performance Surveillance program for internal clinical program and protocols under investigational review board(s).
Parsippany Site quality management representative responsible for site quality compliance and audit hosting for US-based audits and inspections

Job Description
MAJOR TASKS AND RESPONSIBILITIES OF POSITION
  • Lead and oversee the global Commercial Quality organization. Develop a long term strategy for the global Commercial Quality organization and to provide guidance to cross-functional senior management on all commercial quality issues/requirements to support the business.
  • Ensures that the Quality Management System requirements, the Regulatory obligations and practices of Ascensia Diabetes Care are communicated to and implemented by the regional/local management and distributors, where applicable.
Acts as the site quality management representative for Parsippany US Headquarters, responsible for site quality compliance and hosting for site external audits/inspections.
  • Ensures that ADC activities in the Regions and Countries are compliant with applicable regulations and health authority requirements by implementing effective processes and training.
  • Lead the support and training for global Customer Service across all Countries and Regions worldwide, including distributors on products and processes.
  • Responsible for complaint management and product quality processes to ensure complaints are investigated, failures are analyzed for root cause/corrective action, and stop shipments and field corrective actions are implemented appropriately where necessary.
  • Lead and guide continuous improvement process of products through investigation of complaints, corrective actions, and sharing findings with new product development programs.
  • Supervises the review/evaluation of potential adverse information events worldwide in liaison with all necessary partners to reach a final decision regarding notification to local authorities.
Oversee Internal Performance Surveillance responsible for internal clinical program, which provides data for development, regulatory submissions and product surveillance. Sub-investigator for internal clinical studies and protocols under investigational review board(s).

QUALIFICATIONS:
  • Graduate Degree in one of the life sciences or an engineering discipline, or equivalent in experience and training.
  • Ten (10) years of experience in Quality Assurance, Medical Device, Pharmaceutical or IVD industry, at least five (5) years of which are in the management of a scientific discipline.
  • Excellent analytical skills and judgment.- Good understanding of statistical techniques.- Broad understanding of Good Laboratory and Good Manufacturing Practices and a strong knowledge of the Quality Management Systems applicable to Medical Devices.
  • The incumbent must have a thorough understanding of international regulations governing medical devices.
  • Strong organization, communication, leadership, and management skills to direct/influence diverse, multi-disciplinary functions, prepare and manage budgets, and select, train, and motivate a qualified staff and communicate to senior leadership.
  • Superior interpersonal skills to assure open and productive communication within the department, across ADC and among many different cultures to promote collaboration and transparency across the organization.
  • Ability to lead a globally dispersed team and interface with people from different cultures, with varying levels of proficiency in a common language.
  • Proactive, engaged leadership style with demonstrated ability to dig deep into challenges, bringing together the relevant stakeholders to resolve complex issues and deliver required solutions with required quality levels
  • Demonstrated success working in a matrixed environment
  • Demonstrated ability to manage multiple priorities of both a technical and nontechnical nature.
  • Excellent written and verbal communication/presentation skills.
  • This position requires creativity to direct difficult problem-solving activities of a technical and managerial nature. A primary focus is to oversee resolution for issues which are highly complex and require very knowledgeable and sophisticated statistical and scientific approaches for effective resolution.
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