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Apogee Therapeutics · 1 day ago

Associate Director, GMP Quality Assurance

United States

Full-time

Hybrid

Senior Level, Lead/Staff, Director/Executive

$160K/yr - $185K/yr

7+ years exp

Apogee Therapeutics, Inc. is a biotechnology company focused on developing differentiated biologics for various inflammatory and immunology conditions. The Associate Director of GMP Quality Assurance will ensure the quality, safety, and compliance of biologics manufacturing processes and device development activities, working closely with cross-functional teams to enhance Apogee’s quality systems.

BiotechnologyLife ScienceMedicalTherapeutics

H1B Sponsor Likely

Responsibilities

Lead and support QA activities for downstream manufacturing, including Drug Product, Finished Drug Product, and devices such as pre-filled syringes and auto-injectors

Maintain and enhance robust GMP quality systems encompassing documentation, change control, deviations, CAPA, quality events, and continuous improvement initiatives

Stay current with regulatory changes, industry trends, and implement new requirements into company policies and procedures

Utilize risk-based approaches to quality management, proactively identifying and mitigating quality risks across the organization

Develop, monitor, and report key quality metrics to drive GMP compliance and improve product quality

Ensure all personnel are adequately trained in GMP requirements and quality procedures

Keep comprehensive and accurate records and reports of all quality assurance activities

Foster a culture focused on quality, compliance, data integrity, patient safety, collaboration, and teamwork

Prepare and support the organization for regulatory authority inspections and maintain inspection readiness

Collaborate with cross-functional teams to solve problems and drive innovation in quality systems and processes

Qualification

GMP Quality AssuranceBiologics ManufacturingRegulatory ComplianceQuality System RegulationsAnalytical InstrumentationElectronic QMSCommunication SkillsProblem-SolvingProject Management

Required

A bachelor's degree in relevant scientific discipline or equivalent is required

A minimum of 7 years of experience in GMP quality assurance within the biotech or pharmaceutical industry, with direct experience in the manufacture of monoclonal antibodies or biologics

Knowledge of medical device Quality System Regulations with direct experience in 21 CFR Part 4, Part 820, ISO 13485 and ISO 14971

In-depth knowledge of GMP regulations and guidelines, including FDA, EMA, and ICH requirements

Experience with analytical instrumentation, methods, validation, and investigations including stability program management

Experience using electronic QMS to monitor, report, and track quality tasks, and key quality performance indicators

Demonstrated strong oral and written communication skills, along with effective interpersonal abilities to influence, drive change, and foster a collaborative, team-oriented culture

Proven excellence in problem-solving and critical thinking, with flexibility and creativity to address the challenges of a dynamic, growing organization

Skilled in managing multiple projects simultaneously, effectively prioritizing and adapting to aggressive timelines and shifting priorities

Position requires up to 20% travel including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year

Benefits

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

Company

Apogee Therapeutics

Apogee Therapeutics is a biotechnology company that offers therapies for immunological and inflammatory disorders.

Founded in 2022

San Francisco, California, USA

201-500 employees

https://apogeetherapeutics.com/

H1B Sponsorship

Apogee Therapeutics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (2)

2024 (3)