Quality Operation Manager; GMP

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.

Our Mission And Culture At Sobi North America Get Us Excited To Come To Work Every Day, But Here Are a Few More Reasons To Join Our Team

• 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

The Quality Operations Manager is responsible for supporting transition from legacy paper-based processes to a scalable and compliant Electronic Quality Management System (eQMS). This role ensures that the Quality System supports all stages of drug development — from nonclinical development through clinical development, regulatory submission (IND, NDA/BLA), commercialization, and product lifecycle management. The Quality Operations Manager will ensure compliance with applicable GxP requirements (GLP, GCP, GMP), applicable FDA and global regulatory expectations, and industry best practices.

The position supports inspection readiness, regulatory submissions, vendor oversight, and efforts to foster a culture of quality and compliance across the organization.

• eQMS Transition
  • Assess existing paper-based processes and develop a phased transition plan to electronic workflows.
  • Ensure data integrity, Part 11 compliance (where applicable), and appropriate system validation.
  • Support Integration of GXP processes across all GXP functional areas into a unified, risk‑based framework.
• Quality System Management
  • Integrate or as appropriate, develop, implement, and maintain procedures for:
    • Document control
    • Training management
    • Deviations and nonconformances
    • CAPA
    • Change control
    • Risk management
    • Audit management
    • Complaint handling (if applicable)
  • Distribute and coordinate training of GXP procedures
• Support for External Quality Operation, if applicable
• Inspection Readiness & Regulatory Interface Support
  • Inspection readiness programs across the organization.
  • Regulatory agency inspections (e.g., FDA, EMA, other global authorities).
  • Oversee timely and effective CAPA development and implementation in response to regulatory findings.
• Cross-Functional Leadership
  • Collaborate with Clinical, Regulatory, CMC, Nonclinical, IT and Commercial teams.
  • Provide training and promote quality culture across the organization.
  • Serve as a quality advisor to senior leadership.

• Bachelor’s degree (BS) or higher in a scientific discipline (e.g., Biology, Chemistry, Pharmacy, Biomedical Sciences, or related field).

• Direct experience of transitioning from paper-based systems to an Electronic Quality Management System (eQMS).
• Familiarity with:
  • IND and NDA/BLA regulatory submissions
  • Regulatory agency inspections and inspection readiness
  • GxP environments (GLP, GCP, GMP)
• Several years of progressive Quality experience in the pharmaceutical or biotechnology industry.
• Demonstrated experience supporting multiple stages of drug development: research, clinical development, regulatory submission, commercialization, and lifecycle management.
• 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…