Apogee Therapeutics

Associate Director, GMP Quality Assurance

QA EngineerQA EngineerFull TimeRemoteSeniorTeam 51-200H1B No SponsorCompany Site LinkedIn

Location

United States

Posted

68 days ago

Salary

$160K - $185K / year

Seniority

Senior

Bachelor Degree7 yrs expEnglish

Job Description

• 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

Job Requirements

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

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