East Brunswick, New Jersey
| Essential Duties & Responsibilities: Quality Assurance (QA) |
| • Responsible for planning, scheduling, and organizing QA activities related to meeting the compliance, supply, and strategic objectives of the Company |
| • Directs and coordinates internal quality activities of documentation, incoming inspection, certificate of analysis and labelling reviews, annual product reviews, complaint and adverse event monitoring |
| • Directs supplier qualification program and manages external quality activities of CMOs in accordance with quality agreements |
| • Maintains effective CAPA process and ensures timely follow-up and implementation of corrective actions |
| • Responsible for overall planning and management of QA systems to ensure continuous sale of products consistent with established standards and regulatory requirements |
| • Conducts due diligence and ongoing supplier audits, as needed |
| • Acts as subject matter expert regarding all QA practices and procedures for the company as a whole |
| • Monitors the company’s compliance through internal and external audit programs, and provides technical and compliance oversight to the audit team |
| • Writes and reviews SOPs and oversees document and change control processes |
| Essential Duties & Responsibilities: Regulatory |
| • Responsible for the preparation and submission of Abbreviated New Drug Applications, including amendments, supplements, annual reports and related submission documents |
| • Reviews FDA correspondence regarding submissions and initiates necessary actions to ensure timely responses |
| • Serves as an internal resource on FDA matters for the management team, and business development, sales, supply chain and legal departments |
| • Directs the development of new product pipeline approval submissions to meet FDA regulatory review requirements |
| • Maintains approved ANDAs in compliance with FDA regulations with emphasis on strict maintenance of all annual reports and change controls |
| • Responsible for final release to the market and field alert/recall decisions for ANDA owned products |
| • Anticipates future regulatory changes, identifies risks and impact to business success, and takes action to limit the effect on Rising’s business |
| • Maintains an up-to-date knowledge on regulatory matters and advises senior management of potentially significant changes and risks |
| • Is the primary point of contact for FDA and other local regulatory agencies, and leads quality and regulatory teams to prepare for inspections and audits |
| • Establishes and monitors compliance with a periodic review cycle to ensure guidelines/SOPs documents are up-to-date and reflect current practice, and escalates to senior management when appropriate |
| • Creates implements and conducts training for all employees, and provides advice regarding FDA inspections and responding to investigators |
| Essential Duties & Responsibilities: Leadership |
| • Provides planning and leadership to staff by ensuring that appropriate structures, policies, competencies, and values are developed |
| • Provides leadership in developing and implementing regulatory and QA strategies and processes to ensure consistent high quality of all products |
| • Ensures that interfaces between regulatory/QA and other departments, particularly BD, Supply Chain, Operations, and Sales are managed optimally |
| • Is key contributor to business development and sales teams providing QA and compliance input to influence selection of partners and business decisions |
| • Interfaces with customers regarding quality and regulatory issues in support of business development and sales opportunities |
| • Manages decision making and conflict resolution with regard to compliance related activities |
Bachelor Degree is required in Regulatory Affairs or Pharmacy or Pharmaceutical Science.
Read more about Rising’s response to the COVID-19 pandemic here.
Read more about Rising’s response to the COVID-19 pandemic here.
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