Sobi
External Quality Operation Manager (GMP)
Raleigh, NC, United States
Sponsorship not specified$120k-$140kDetected 13 days ago
StatisticsSupply ChainGMPFDA RegulatoryResearchLeadershipCollaborationMentoringOrganizational SkillsRegulatory Affairs
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
- Perform as EQOM to act as Single point of contact for all quality related activities at the Contract Manufacturing Organization (CMO)
- Support release products to Markets
- Support the External Service Provider (CMO) Qualification
- Drive or support improvement opportunities for processes and product Quality performance
- Manage/approve quality issues (deviations, CAPA and complaints) as per QTA and Sobi requirement
- Support that Quality Audits of the CMO are performed according to Sobi requirement and the QTA
- Lead to define strategy of implementation and monitoring of key Quality transformation initiatives and align with all process stakeholders outside of Quality organization
- Lead or act as Quality representative in projects related to CMO eg Tech Transfer, Launch
- Support HA inspections/audits of Sobi
- You're confident operating in a global, fast‑moving environment, using your leadership and interpersonal skills to influence external partners and drive collaborative decisions.
Requirements
- More than 5 years of experience within pharmaceutical, biotech product.
- Experience in QA operation, production or other relevant area (GMP, GDP)
- More than 1 years of managing external quality oversight of CMOs
- Ensure the batch release as required
- Strong understanding of risk assessment and risk management fundamentals / tools
Compensation
- $120k-$140k
Benefits
- Proven track record with FDA; EMEA or other Health Authorities
- We offer a competitive benefits package to support the health and happiness of our staff.
Company info
- 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.
This listing is sourced directly from Sobi's careers page and normalized into a canonical job model.