Internal Quality Operations Manager

Candidates must reside within commuting distance to either either San Diego CA or Morrisville NC due to the hybrid nature of the job.

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.

Qualifications :

Education

• Bachelors 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(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.

Additional Information :

Compensation and Total Rewards at Sobi

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 $112000-$150000. 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 Sobis 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.

Why Join Us

We are a global company with over 1900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins and a Board with a stellar track record were ready to take on the worlds diseases ailments and adversity. Our people believe they have the power to make a positive impact in others lives because thats exactly what we do here. If youre seeking a career that taps into your talents in a way that makes the world a better healthier place we just may have a job for you.

We know our employees are our most valuable asset and our culture conveys that. We offer a competitive benefits package to support the health and happiness of our staff.

Sobi Culture

At Sobi we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one but we know we cant 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.

An Equal Opportunity Employer

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.

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Remote Work :

No

Employment Type :

Full-time