Assist CQA Leadership with development and execution of CQA audit plans supporting Apogee clinical study programs
Perform or provide oversight of assigned GCP audits e.g. clinical investigator sites, clinical vendor qualifications, trial master files, internal processes and clinical study documents with minimal supervision
Act as CQA lead representative at clinical study team meetings and other study related meetings
Partner with clinical functions to provide quality guidance as required to drive the implementation of fit for purpose procedures that support clinical data and documentation generated activities are executed in compliance with GCP
Facilitate and/or review the investigation of reported quality events to evaluate the appropriateness of CAPAs proposed to mitigate risk of issue re-occurrence
Contribute to the development and maintenance of clinical QA procedures and other governance standards as assigned
Assist in the periodic reporting of key quality metrics to leadership to assist in driving improvements in GCP compliance across the organization
Assist in the development and/or delivery of GCP training topics and quality standards as directed
Assist QA Leadership in fostering a culture of quality and continuous improvement within the organization, emphasizing the importance of compliance, data integrity, and patient safety in support of corporate goals
Collaborate with clinical functions to support inspection readiness activities
Perform key activities during regulatory authority inspection and/or external audits as directed by Head of CQA

Requirements

Bachelor's degree in a relevant biological sciences or equivalent is required, advanced degree a plus
8-10 years professional experience in Quality Assurance within the biopharma industry, including increasing responsibilities in the Clinical QA function
Minimum of 6 years of direct audit experience in GCP
In-depth working knowledge of GCP regulations and guidelines, including FDA, EMA, and ICH requirements
Extensive experience using electronic QMS to monitor, report, and track quality tasks and key quality performance indicators
Excellent problem-solving and critical thinking abilities
Ability to manage multiple projects with aggressive timelines and changing priorities
Position requires up to 25% travel including mandatory in-person attendance at All Hands meetings typically held twice per year

Benefits

A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

GCP auditsclinical investigator sitesclinical vendor qualificationstrial master filesCAPAsclinical QA proceduresquality metrics reportingGCP trainingregulatory authority inspectionaudit experience

Soft skills

problem-solvingcritical thinkingproject managementcollaborationcommunicationleadershiporganizational skillsadaptabilityattention to detailcontinuous improvement