Description:

• Product Quality team is seeking an enthusiastic, highly motivated, and team-oriented leader for the position of Principal Product Quality Leader.
• As Principal Product Quality Leader, you will provide technical expertise and leadership within a Product Quality Team.
• You will engage with Product Quality, International Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other departments on a variety of activities.
• Such activities include product filings, program improvements, and investigations associated with product manufacturing, in-process controls, analytical methods, specifications, stability, reference standards, importation testing, change control, regulatory submissions and inspections.
• You will support one or more of late-stage or commercial synthetic products and provide technical expertise and project support to the Product Quality Team(s) to develop, implement, and manage strategies to meet the Product Development Team goals.
• You will be directly responsible for Product Quality related activities including ownership, authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems (such as change control), and product data management including comparability assessments, annual product reviews, and product quality risk assessments.
• Your contributions will significantly improve initiatives intended to ensure the overall product health.

Primary Responsibilities include the following:

• Provide effective, cross-functional quality leadership, and support program deliverables for late phase and commercial programs
• Author and revise annual reviews, specifications, comparability, and stability programs; site and method transfers; product quality impact assessments; and author regulatory filing sections and RTQs
• Conduct science and risk-based evaluation of complex process and product quality data
• Communicate effectively with oral and written communication of complex information to Product Quality leadership, peers and regulatory agencies
• Extract and analyze data from various sources and Quality systems
  Demonstrate proficiency in knowledge of cGMP and international regulatory expectations.