Director, Quality Control

NewAmsterdam Pharma Corporation

1d•Remote

About The Position

NewAmsterdam is an innovative biotech company with the experience and expertise to deliver across its ambitious clinical, regulatory, and commercial goals. Our robust scientific approach focuses on advancing a new era of life-saving treatments for lipid-related diseases. Our vision is that people at risk for heart disease can take control of their health and live longer, fuller lives. Our team is led by a world-class team of industry veterans and key opinion leaders, including some of the world’s preeminent cardiometabolic experts and we foster a passionate, supportive culture that is backed by a high level of integrity and inclusivity. Director, Quality Control Director, Quality Control is responsible for managing the Quality Control tasks and reports into the NAP Quality Team. Review 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. This role includes 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). Analyze data and metrics relate to quality control to identify trends, patterns, and areas for improvement. Establish and maintain 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. The position requires significant pharmaceutical experience and attention to detail.' This role reports to the Senior Director, QA and QC. Remote position with some travel. Key Responsibilities: Quality Control: Responsible for NAP Quality Control including the review of clinical and commercial testing data and CoAs, Stability reports, Method Validation and Verification protocols and reports, and Technical Transfer reports. Oversee all Vendor QC laboratory operations, in conjunction with the NAP Analytical team, ensuring compliance with FDA, EMA, Health Canada, and Rest of Work regulatory requirements as well as Global regulatory and ICH guidelines. Assist with creating and managing the appropriate quality management system, procedures and records. Review, edit, respond, and organize CDMOs deviations, OOS, and OOTs Ensure data integrity. Approve technical documents like validation reports and batch records. Stability program leadership: develop, implement, and maintain a comprehensive stability program in accordance with ICH guidelines. May include interacting with regulatory agencies. CMC and Regulatory Support 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.

Requirements

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 is using quality control tools and software, such as statistical analysis software, quality management systems and AI.

Responsibilities

Responsible for NAP Quality Control including the review of clinical and commercial testing data and CoAs, Stability reports, Method Validation and Verification protocols and reports, and Technical Transfer reports.
Oversee all Vendor QC laboratory operations, in conjunction with the NAP Analytical team, ensuring compliance with FDA, EMA, Health Canada, and Rest of Work regulatory requirements as well as Global regulatory and ICH guidelines.
Assist with creating and managing the appropriate quality management system, procedures and records.
Review, edit, respond, and organize CDMOs deviations, OOS, and OOTs
Ensure data integrity.
Approve technical documents like validation reports and batch records.
Stability program leadership: develop, implement, and maintain a comprehensive stability program in accordance with ICH guidelines.
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.