Quality Operation Manager (GMP)

Quality Operation Manager (GMP)

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

Job Description

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

• 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 standards

• 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 $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.

Why Join Us? We are a global company with over 1,900 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, we're ready to take on the world's diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others' lives because that's exactly what we do here. If you're 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 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.

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