Quality Operation Manager (gmp)

Quality Operation Manager (Gmp)

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.

Key Responsibilities/Scope of the Job:

• 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.

Education

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

Experience

• 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 company growth, regulatory milestones, and long-term commercial success.

Personal Attributes:

• Strong systems thinker with ability to integrate cross-functional processes.
• Hands-on execution capability.
• High attention to detail and strong documentation skills.
• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Proactive, organized, and capable of working in a fast-paced, evolving environment.
• Demonstrated integrity and commitment to quality and compliance.

At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards.

The base salary range for this role is $112,000-$150,000. Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short-term and long-term bonuses, as outlined in the plan details.

All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.

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.