Product Quality Associate Director

Roles & Responsibilities:

• Provide effective, cross-functional leadership of the PQ AIN team
• Support PQ deliverables 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 RTQs
• 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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Doctorate degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 3 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 and 3 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
• 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 cross-functional relationships and strong partnerships through written and verbal communication skills

Preferred Qualifications:

• Experience working virtually on a cross-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:

• Management, 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