Sobi
Quality Operation Manager (GMP)
San Diego, CA, United States
Sponsorship not specified$112k-$150kDetected 6 days ago
GCPStatisticsProduct ManagementGMPFDA RegulatoryResearchLeadershipCommunicationProblem SolvingGxP
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
- Assess existing paper-based processes and develop a phased transition plan to electronic workflows.
- Support Integration of GXP processes across all GXP functional areas into a unified, risk-based framework.
- 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.
Nice to have
- Working knowledge of applicable regulations including 21 CFR Parts 210, 211, 312, 820 (if applicable), ICH guidelines, and related global standard
- Experience with validating eQMS platforms and computerized system validation (CSV/CSA) is a plus.
- This role may require occasional travel to vendor sites or regulatory agency meetings.
- The Quality Manager may serve as Management Representative for the Quality System, where applicable.
- This is a critical role supporting company growth, regulatory milestones, and long-term commercial success.
Skills
- High attention to detail and strong documentation skills.
- Excellent communication and interpersonal skills.
Compensation
- $112k-$150k
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.