Sr. Associate, AS Systems

• Drive quality mindset for the AS department (GxP and non-GxP activities) by developing training tools and monitoring quality practices in the group
• Support compliance oversight of AS laboratory equipment, coordinating qualification processes and maintaining GxP readiness
• Investigate, manage, and own laboratory investigations, deviations, and CAPAs when required for Systems & Operations. Manage and own change control records when required for Analytical Sciences.
• Ensure compliance with regulatory requirements and industry standards. Participate in inspection readiness, regulatory inspection support and self-inspection activities.
• Support key focus areas within Systems & Operations: Safety, Training, Data Integrity/Management, Equipment Management, etc.
• Identify, initiate, and drive continuous improvement initiatives to improve policies, procedures, and business practices.
• Perform gap assessments, monitor and analyze performance metrics to identify areas for improvement.
• Track progress against project timelines, generate regular status updates and communicate progress, resourcing needs and issues to leadership.
• Develop and deploy training content for process improvement initiatives.
• Work with cross-functional teams to meet company objectives and ensure alignment.
• Other duties as assigned.

• Minimum of 6 years within the biotechnology/pharmaceutical industry.
• Strong knowledge of QMS, current Good Laboratory and Good Manufacturing Practices, and phase-appropriate Quality principles and compliance requirements
• Understanding of all aspects of analytical test method lifecycle, including phase appropriate regulatory requirements/guidelines (e.g., ICH), method qualification, method transfer, and method validation.
• Hands-on laboratory experience in the biotechnology industry or academic setting.
• Familiar with use of statistical software, electronic document management, laboratory information management, and QMS systems.
• The ability to lead cross-functional teams, drive initiatives, and effectively influence stakeholders at all levels of the organization.
• Demonstrates the ability to work independently, proactively identifying opportunities and taking actions. Must possess the ability to perform routine and non-routine tasks under minimal supervision.
• Proven flexibility and execution skills to deliver in a fast-paced, multi-tasking environment. Ability to work with ambiguity and complexity.
• Excellent communication skills, both written and verbal, with the ability to effectively communicate requirements and strategies to diverse audiences.
• Strong analytical and problem-solving skills. Ability to effectively analyze complex problems and present results effectively.
• Eagerness to learn and develop as an individual

• Project Management experience
• Operational Excellence and/or Six Sigma experience

• Bachelor's degree in life sciences or related field (e.g. biology, chemistry, engineering)
• Advanced degree desirable, but not required
• Project management, lean six sigma, and/or quality certification(s) are desirable

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.