QA Manager, GCP

At Sobi, we believe diversity drives innovation and inclusion creates stronger teams. We are committed to building a workplace where everyone feels valued and empowered to contribute. If this role excites you but you’re unsure if you meet every requirement, we encourage you to apply. Your unique perspective and experiences could be exactly what we need.

About the Role

Due to the hybrid nature of the job, candidates must reside within commuting distance to Raleigh, NC. The QA Manager, GCP is responsible for ensuring quality oversight and quality assurance and quality by design activities related to GCP/GCLP area. This includes providing quality guidance and support for GCP/GCLP and GPP-related activities within Sobi, such as audits, inspections, and risk assessment of BLA/NDA/IND/CTA submissions under the global umbrella.

Responsibilities

• Ensure GCP audit management excellence of the end-to-end audit management process and overview of the assigned audits, as planned.
• Assess and approve from a quality perspective the GCP deviations (global and local, as applicable), GCP-related CAPAs.
• Prepare regular status reports on performed audits, audit trending, deviation trending, CAPAs trending, and agreed-upon metrics to ensure quality oversight.
• Contribute and support the GCP audit risk assessment according to SOPs.
• Ensure active contribution in the cross-functional team with procurement, business owners for GxP, and Quality requirements, and documented qualification of GCP service providers. Review provisions in contracts/Quality agreements, as applicable.
• Serve as QA representative during GCP inspections at global and site levels, as applicable, and contribute to the Inspection Readiness framework while promoting a continuous quality mindset across Sobi.
• Author GCP QA-related processes, review, and provide guidance under the global umbrella.
• Support the collection of data needed for the Audit program risk assessment.
• Support clinical studies-related activities from a quality perspective across Sobi.
• Ensure qualification of global and local ESP, as applicable, in GCP-regulated areas per Sobi procedures.

Requirements

• University degree or similar in Life Sciences or a related discipline.
• 5+ years of pharmaceutical industry experience in Clinical Quality Assurance or in the operational conduct of clinical trials and the application of GCP audit and/or Quality Assurance experience.

Skills

• Technical Skills:
  • Excellent knowledge of applicable ICH GCP guidelines, industry best practices, and FDA, EMA, and ROW regulatory requirements.
  • Understanding of quality assurance activities principles and know-how.
  • Documented education/experience in QA systems and preferably auditing.
• Soft Skills:
  • Structured with a focus on results and detail-oriented.
  • Strong interpersonal skills with a communicative and flexible attitude.
  • Proactive and collaborative mindset.
  • Strong multi-tasking abilities with high resilience to stress and adaptive skills.

Benefits

• 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.

Pay

The base salary range for this role is $112,000-$153,000. 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.

About Us

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.

We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. 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.

As a specialized biopharmaceutical company, we are dedicated to rare diseases and 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.