QA-Manager Numira Biosciences

Position Summary:

Numira seeks an experienced professional to assume the role of Quality Assurance Manager. This is a full-time position and is based at our offices in Bothell, WA. The Quality Assurance Manager is responsible for monitoring GLP studies.

The successful candidate will have excellent interpersonal, written, and oral communication skills; have the ability to work independently as well as within a team; and be able to exercise good judgment in decision-making. The candidate must also have extensive experience in a QA department in a GLP environment in the biotech or pharmaceutical industry. Excellent organizational skills, attention to detail, and knowledge of FDA GLP regulations are vital to this position.

Status: Full-time

Responsibilities:

Communicating compliance assessments to upper management.
Responsible to review documents generated to meet GLP requirements.
Oversees audits of study conduct, facilities, and processes.
Oversees document management (SOP) system.
Oversees maintenance of training files for all Numira Biosciences personnel and CVs for external consultants.
Oversees maintenance of QA files.
Oversees archives.
Administers performance requirements for staff in the Quality Assurance department.
Monitors GLP studies and assures facility management that studies are in compliance with the applicable regulations.
Performs critical phase inspections of studies to assure compliance with GLPs/study protocols/SOPs, provides report of findings to Study Director and Testing Facility Management.
Audits data and final reports, and provides Quality Assurance Statements for inclusion in Final Reports.
Performs or coordinates vendor audits of subcontractor laboratories to assure compliance with GLPs; provides report of findings to Study Director and Testing Facility Management.
Reviews / edits existing and authors new QAU Standard Operating Procedures, as appropriate. Reviews other Standard Operating Procedures and provides editorial comments and comments regarding compliance issues as necessary.
Provides training and resources to staff relating to regulatory compliance and quality. Provides assistance to management, staff, clients and subcontractors, where necessary, to help them meet their regulatory requirements.
Applies knowledge of good laboratory practices (GLP) on a daily basis, informally and formally. Communicates with staff verbally and in writing regarding regulatory interpretations.
Hosts site visitors and auditors from sponsor organizations and regulatory agencies.
Maintains associations with industry colleagues, professional organizations, and regulatory liaisons; keeps abreast of regulatory initiatives and interpretations.
Follows established safety policies, procedures and practices. Upholds and promotes Numira Biosciences Core Values.
Other duties as assigned.

Requirements:

BS/BA degree in a scientific field and 7+ years working in regulated environments, including 2+ years of management/supervisory experience, or equivalent combination of education and experience.
Extensive knowledge of computer systems and their applicability/compliance in regulated environments.
Work experience in a GLP QA department in a biotech or pharmaceutical research facility is required; experience with toxicology, histopathology and/or bioassays preferred.
Managerial experience or overseeing several GLP studies is preferred.
Equivalent education and experience will be considered.
Experience in a CRO setting preferred.

Numiras success is predicated on its ability to recruit and retain highly qualified and motivated people in all areas of the company. Numira is an equal opportunity employer and offers a very competitive compensation and benefits package.

Location:	Bothell, WA United States