|Position Title:||Associate Director, QA||Department:||Quality Assurance|
|Reports To:||CEO||Work Location:||East Brunswick, New Jersey|
|Essential Duties & Responsibilities:|
|· Responsible for planning, scheduling, and organizing QA activities related to meeting the compliance, supply, and strategic objectives of the Company.
· Direct and coordinate internal quality activities of documentation, incoming inspection, certificate of analysis and labeling reviews, annual product reviews, complaint, and adverse event monitoring
· Manage supplier qualification program and manage external quality activities of CMOs in accordance with quality agreements.
· Maintain an effective CAPA process and ensure timely follow-up and implementation of corrective actions.
· Responsible for overall planning and management of QA systems to ensure the continuous sale of products consistent with established standards and regulatory requirements.
· Direct cross-functional teams to manage contracts and partner sites for development, manufacturing, packaging, testing, and release of the Company’s commercial and pipeline projects.
· Provide planning and leadership to staff by ensuring that appropriate structures, policies, competencies, and values are developed.
· Provide leadership in developing and implementing QA strategies and processes to ensure consistent high quality of all products Ensure that interfaces between QA and other departments, particularly Regulatory, BD, Supply Chain, Operations, and Sales are managed optimally
· Prepare management reports, defining and evaluating problems and recommending solutions.
· Assist in the review and revision of SOP’s, protocols, and special studies required for compliance with batch records. Assures compliance to SOP and cGMP for routine operations.
· Monitor the company’s compliance through internal and external audit programs and provide technical and compliance oversight to the audit team.
· Manage decision making and conflict resolution with regards to compliance related activities
· Provide subject matter expertise to business development and sales teams to influence the selection of partners and business decisions
|Required:||Bachelor’s degree is required in Pharmaceutical Science of Pharmaceuticals or Pharmaceutical Manufacturing or Pharmaceutical Engineering|
|Required:||• A minimum of seven (7) years of cGMP quality assurance experience in the biotechnology, pharmaceutical, or medical device industry.
• Experience with review and disposition/product release of manufacturing and packaging batch records.
• Working knowledge writing and following SOPs, document management/control system processes
|Specialized Training or Technical Knowledge Licenses, Certifications Needed:|
|• Working knowledge of MS Word, Excel, Outlook, and PowerPoint|
|• Working knowledge of Adobe Acrobat|
|• Excellent conceptualizing, analytical and problem-solving skills|
|Company / Industry Related Knowledge:|
|Job Specific Competencies:|
|• Effective written and oral communication skills|
|• Strong organizational, planning, and communication skills.|
|• Demonstrates exceptional time management skills.|
|• Using logic and reasoning to identify solutions to problems.|
|• Ability to multi-task, set priorities and meet strict deadlines.|
|• Ability to lead, motivate, coach, and teach others|