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.

NewAmsterdam Pharma (NAP) is seeking a Manager/Senior Manager, Quality to assist in the overall management of end-to-end GxP quality activities for NAP manufacturing programs. Primary responsibilities will be to ensure quality and compliance of NAP’s development program with respect to QMS management, controlled documents, and applicable regulatory requirements (FDA/ICH/EMEA, and current industry standards and practices) are conducted in a compliant manner. This is a remote position and will report to the Senior Director, Quality.

Key Responsibilities:

Provide GxP (GMP, GCP, GLP, GVP) support to cross functional teams
Ensure compliance with all applicable global GxP regulations and guidelines
Develop, review and approve GxP controlled documents, such as: Policies, Standard Operating Procedures (SOPs), Work Instructions, and supporting documents related to GxP activities
Ensure quality systems, processes, specifications, and SOPs are appropriate for clinical manufacturing, release and distribution of quality product meeting relevant regulatory requirements, applicable standards and guidance
Assist in phase appropriate oversight of systems and optimize systems as they move from clinical to commercial phases
Assist in maintenance of internal tracking and management of processes overseeing deviations, CAPA, change controls, document changes, temperature excursions, and others as assigned
Assist in coordination and conduct of routine and non-routine quality assurance audits including: CROs/vendors, process, system, and document reviews to assure quality assurance compliance with regard to all internal procedures as well as regulatory guidelines; this will include conducting audits
Participate in internal audits to identify areas of improvement and collaborate with stakeholders to implement effective and sustainable corrective measures
Act as a liaison with Quality counterpart at vendors
Establish and maintain quality oversight of vendors including participating in design and execution of vendor assessments, establishing/monitoring compliance to Quality Agreements, and developing/utilizing quality metrics to track vendor performance
Conduct Quality review of vendor master and executed batch records, stability protocols, validation protocols/reports and analytical protocols, methods and reports
Conduct product release of drug substance, drug product, packaged and labeled product
Assist in evaluation and escalation (as appropriate) of product quality issues
Ensure timely and effective follow-up of all identified or assigned quality issues
Provide quality support to internal and external Change Controls assessing product quality and regulatory impact
Provide Quality support for deviations, complaint investigations, and OOS/OOTs, assessing for product quality and program impact. Partner with internal and external stakeholders to drive issue resolution, CAPA identification and ensure timely closure
Review and verify data to ensure compliance with data integrity and regulatory requirements, as appropriate
Support preparation of CMC investigational and commercial regulatory submissions by reviewing and approving relevant documents per program timelines and associated Health Authority (HA) information requests, as required
Support related activities in preparation for HA inspections and support interactions during HA inspections
Assist in generation, tracking and trending of Quality System compliance metrics and compile metrics and information for Quality Management Team reports
Continuously improve and maintain Quality Systems related to GxP activities, maintain documentation for compliance with quality and regulatory standards
Organize and promote company-wide quality system continuous improvement programs.
Evaluate and develop improved systems and processes for the control of quality, reliability, and safety of investigational products

Requirements:

Bachelor's degree in a scientific discipline, advanced degree a plus
7+ years in the pharmaceutical industry, with a minimum of 5 years in Quality
Solid understanding of GxP standards, policies, and procedures (domestic and international)
Experience and understanding of small molecule drug substance and non-sterile oral solid dosage drug product manufacturing a strong plus
GMP vendor auditing experience a strong plus
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

Salary and Benefits:

We offer a competitive base salary range, commensurate with experience. In addition to the salary, we provide a comprehensive benefits package, including health insurance, dental and vision coverage, term life and disability coverage, retirement plans, and stock option awards.

NewAmsterdam Pharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information, or any other basis protected by federal, state or local law.