[Hiring] Director, Quality Control @NewAmsterdam Pharma Corporation

Role Description

The Director, Quality Control is responsible for managing the Quality Control tasks and reports into the NAP Quality Team. This role includes:

• Reviewing CMO QC laboratory operations, ensuring compliance with regulations such as FDA, EMA, Health Canada, and Rest of Work regulatory requirements as well as Global regulatory and ICH guidelines.
• Supporting analytical development in a quality role; ensuring data integrity.
• Creating, reviewing, and approving technical documents (such as stability reports, method validation and method verification protocols and reports, and final analytical release data).
• Analyzing data and metrics related to quality control to identify trends, patterns, and areas for improvement.
• Establishing and maintaining relationships with suppliers and vendors to ensure compliance with quality control standards.
• May be a subject matter expert for regulatory submissions and inspections related to Quality Control tasks and data.

This role reports to the Senior Director, QA and QC. It is a remote position with some travel.

Qualifications

• Bachelor's degree in a Chemistry or similar scientific discipline, advanced degree preferred.
• 8-10 years in the pharmaceutical industry working in QC.
• Strong understanding of analytical testing methods and records.
• Deep understanding of GxP standards, policies, and procedures (domestic and international).
• Experience and strong understanding of small molecule drug substance and non-sterile oral solid dosage drug product testing.
• Experience working with CDMO/Contract manufacturing and contract laboratories.
• Excellent verbal and written communication skills.
• Collaborative problem-solver, ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations.
• Ability to continuously re-prioritize and work independently, as a member of a cross-functional team, and with external vendors with minimal supervision.
• Ability to travel domestically and internationally, approx. 10-15% of the time.
• Remote position, US Eastern work hours expected.
• Proficiency in using quality control tools and software, such as statistical analysis software, quality management systems, and AI.

Requirements

• Significant pharmaceutical experience and attention to detail.
• Support the CMC Analytical teams in analytical method transfer to various CDMOs and partners.
• Support preparation of CMC investigational and commercial regulatory submissions by reviewing and approving relevant documents per program timelines and associated HA information requests.
• Provide significant CDMO-focused regulatory filing input and ensure product-focused pre-approval inspection and commercial readiness activities at the CDMOs.
• Together with cross-functional stakeholders, coordinate and manage compliance-related activities in preparation for Health Authority inspections and support interactions during Health Authority inspections.
• Perform internal and external audits.
• For the EU, work with the selected EU Designated Person to ensure Good Distribution Practices.

Benefits

• Competitive base salary, commensurate with experience.
• Comprehensive benefits package, including health insurance, dental and vision coverage, term life and disability coverage, and retirement plans.
• Annual bonus and long-term incentives.