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Sobi - Swedish Orphan Biovitrum AB (publ) • Raleigh, North Carolina, United States
Salary: $112,000 - $153,000 / year
Role & seniority: QA Manager, GCP (mid-to-senior level)
Stack/tools: GCP/GCLP/Good Pharmacovigilance Practices; QA systems; audits; risk assessment; SOPs; ICH GCP; FDA/EMA/ROW regulatory knowledge; CAPA management; contract/quality agreement reviews
Oversee end-to-end GCP audit management and provide quality oversight across global/local audits
Assess/approve GCP deviations and GCP-related CAPAs; prepare status, trending, and metrics reports
Support GCP-related risk assessments, inspections readiness, and cross-functional QMS with procurement, sponsors, and service providers
University degree in Life Sciences or related field; 5+ years in Clinical QA or operational clinical trials with GCP auditing/QA
Deep knowledge of ICH GCP, FDA/EMA/ROW requirements; QA systems and auditing principles
Strong documentation, communication, and cross-functional collaboration; results-oriented, detail-focused, resilient under pressure
Experience with audits/quality reviews of BLA/NDA/IND/CTA submissions; qualification of global/local ESPs
Experience drafting/guiding quality agreements and contractual QA provisions; inspection readiness program contribution
Location & work type: United States; full-time role within Sobi North America (onsite/remote flexibility not specified)
Company Description Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application! At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.
We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.
We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.
Sobi Culture
At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.
As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth. An Equal Opportunity Employer
Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to [email protected] Know Your Rights
Sobi Location: United States