Sobi
QA Manager, GCP
San Diego, CA, United States
Sponsorship not specified$112k-$153kDetected 144 days ago
GCPStatisticsAuditingProcurementClinical TrialsFDA RegulatoryResearchGxP
About the role
- 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.
Responsibilities
- Contributeand support the GCP audit risk assesment according to SOPs.
- 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.
Requirements
- University degree or similar in Life Sciences or related discipline.
- At least 5 years experience from the pharmaceutical industry in Clinical Quality Assurance or in the operational conduct of clinical trials and the application of GCP audit and/or Quality Assurance experience.
Skills
- Excellent knowhow of the applicable ICH GCP guidelines, industry best practices and FDA, EMA and ROW regulatory requirements.
- Quality assurance activities principles and know-how
- Documented education/experience in QA systems and preferably auditing
- Structured with focus on results and detail oriented
- Strong interpersonal skills with communicative and flexible attitude
- Proactive and collaborative mindset
- Strong multi-tasking abilities with high resilience at stress and adaptative skills
- Compensation and Total Rewards at Sobi
- Each individual offer will be determined based on several factors, including your experience, qualifications, and location.
- All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.
- Come join a culture that empowers every person to be the person that makes a difference for rare disease.
- Why Join Us?
Compensation
- $112k-$153k
Benefits
- We offer a competitive benefits package, to support the health and happiness of our staff.
Company info
- Competitive compensation for your work
- Generous time off policy
- Opportunity to broaden your horizons by attending popular conferences
- Emphasis on work/life balance
- Collaborative and team-oriented environment
- Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments
- We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate.
- We know our employees are our most valuable asset, and our culture conveys that.
- At Sobi, we refuse to accept the status quo.
- As a specialized biopharmaceutical company, we are dedicated to rare diseases.
Equal opportunity
- An Equal Opportunity Employer
- Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.
This listing is sourced directly from Sobi's careers page and normalized into a canonical job model.