Product Quality Specialist

This role will support one or more late-stage and/or commercial biologics or synthetics products. The individual will provide project support to the relevant Product Quality Team (PQT) to implement and manage strategy for Quality to meet the Product Quality goals. The individual will be directly responsible for Product Quality related tasks including authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems (document management system, complaint resolution system, data systems), and product data management, including stability, comparability assessments, periodic and annual product reviews (APR). In addition, the candidate will be expected to play a role in supporting Product Quality initiatives intended to ensure the overall product health.

• Support PQ work for late-stage and/or commercial biologic or synthetic programs, including actions required for the PQT, APR, specifications, comparability, stability programs, and PQ owned regulatory filing sections and responses to questions (RTQ)
• Support science and risk-based evaluation of complex process and product quality data such as in-process, release and stability data, complaints, method performance etc.

Basic Qualifications and Experience:

• Doctorate degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 2 years of Quality, Operations, Scientific, or Manufacturing experience, or
• Masters degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 6 years of Quality, Operations, Scientific, or Manufacturing experience, or
• Bachelors degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 8 years of Quality, Operations, Scientific, or Manufacturing experience or

Must-Have Skills:

• Demonstrate proficiency in oral and written communication of complex information to Product Quality team members and peers
• Demonstrate proficiency in knowledge of cGMP and international regulatory expectations
• Strong scientific data management and organization skills with attention to detail
• Ability to deliver high quality results and adhere to project timelines using computer-based GMP Quality systems
• Ability to build and maintain multi-functional relationships and strong partnerships through written and verbal communication skills

Good-to-Have Skills:

• Experience working virtually on a multi-functional team in a matrix environment across multiple time zones
• Expertise in computer applications such as Veeva, Spotfire, SHINY
• Expertise in MS Office (Word, Excel, PowerPoint, MS Teams)

Soft Skills:

• Analytical and problem-solving skills
• Ability to work effectively with global, virtual teams
• High degree of initiative and self-motivation
• Ability to manage multiple priorities successfully, react quickly to address urgent requests and meet challenging timelines
• Team-oriented, with a focus on achieving team goals
• Strong presentation and public speaking skills