Principal Product Quality Leader

Duration:15 months contract
Shift: Standard Working Hours

• Corporate 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.
• Offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines. Many of the technologies we’re employing are not only new to but are new to the industry as a whole. Help us to pave new roads for helping patients.

• 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

• Doctorate degree and 3 years of experience OR
• Masters degree and 5 years of experience OR
• Bachelors degree and 7 years of experience OR
• Associates degree and 12 years of experience OR
• High school diploma / GED and 14 years of experience

• Prior Biotech experience
• Good communication skills
• Attention to detail
• Understanding of operations
• Tactical in nature- able to receive tasks and work independently once trained (will be training period)

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit

"US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"

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