Quality Intelligence Manager – Strategy

Role Overview

• Serve as Manager, Quality Intelligence & Strategy with a focus on GMP and compliance processes to fulfill MAH/Sponsor responsibilities. This includes designing, maintaining, and optimizing the process landscape to support compliance and operational excellence.
• Support discussions and decision making with strategic partners on complex GMP and compliance topics. Responsibilities include coordinating and preparing comprehensive documentation and organizing/assisting Quality forums and governance committees to ensure alignment and collaboration.
• Provide clear guidance to cross functional stakeholders, promoting a strong Quality culture across the organization. This includes effective communication, advisory support to peers, and cross network collaboration to achieve company objectives while maintaining compliance.
• Contribute to the continuous improvement of the Pharmaceutical Quality System in accordance with EU GMP Guide Chapter 1, ICH Q10, and applicable regional/national regulations.
• Ensure regional and global compliance in the capacity of an MAH/Sponsor representative by addressing evolving global regulatory expectations.
• Implement new processes to strengthen MAH/Sponsor oversight and improve the visualization, transparency, and sharing of key Quality information with stakeholders.
• Lead and support Quality Board processes, ensuring effective evaluation of Quality metrics, trends, and compliance related data to facilitate informed decision making and continuous improvement.
• Proactively maintain, analyze, and report relevant Quality metrics, identifying risks and implementing mitigation strategies to ensure compliance and operational efficiency.
• Support inspections and audits related to MAH/Sponsor responsibilities, including preparation, coordination, and follow up activities. Ensure inspection readiness and provide subject matter expertise during regulatory interactions.

Requirements

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum of 5 years of experience in Quality Assurance, GMP compliance, and regulatory processes within the pharmaceutical industry.
• Demonstrated experience managing MAH/Sponsor responsibilities and Quality Management System (QMS) frameworks.
• Strong knowledge of GMP guidelines, ICH Q10, 21 CFR Part 211, and relevant regional/national regulatory requirements.
• Exceptional communication and collaboration skills with the ability to influence and work effectively across teams and stakeholders.
• Excellent written and verbal communication skills in English.
• Strong analytical and problem solving skills with the ability to navigate complex compliance challenges and drive solutions.

Benefits

• Medical, Dental and Vision Insurance
• Life, AD&D, Critical Illness Insurance
• Pre-tax HSA & FSA, DCRA Spending Accounts
• Employee Assistance & Concierge Program (EAP) available 24/7
• Parental and Childbirth Leave & Family Planning Assistance
• Sitterstream: Virtual Tutoring & Childcare Membership
• Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown
• 401(K) Plan with Company Match
• Tuition Reimbursement & Student Loan Assistance Programs
• Wellbeing Incentive Platforms & Incentives
• Professional Development Programs
• Commuting Allowance and subsidized parking
• Discounted Home, Auto & Pet Insurance
• …and more!