87 applicants

Company

NewAmsterdam Pharma Corporation · 6 hours ago

Senior Manager, Quality Assurance

United States

Full-time

Remote

Senior Level, Lead/Staff

7+ years exp

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Responsibilities

Provide GxP (GMP, GCP, GLP, GVP) support to cross functional teams

Ensure compliance with all applicable global GxP regulations and guidelines

Manage QA for products in phase 2 and late phase 3 pre-validation and commercialization

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 late phase 3 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: CMOs/vendors, process, system, and document reviews to assure quality assurance 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 CMOs/vendors

Establish and maintain quality oversight of CMOs/vendors including participating in design and execution of vendor assessments, establishing/monitoring compliance to Quality Agreements

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 proactive 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 reporting

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

GxPQuality AssurancePharmaceutical IndustryRegulatory ComplianceClinical ManufacturingControlled DocumentsSOP DevelopmentAuditingCAPA ManagementChange ControlData IntegritySmall Molecule ManufacturingRegulatory Submissions

Required

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 Assurance

Solid understanding of GxP standards, policies, and procedures (domestic and international)

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