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.

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

Due to the hybrid nature of the job, candidates must reside within commuting distance to Raleigh, NC

The QA Manager, GCPis responsible for:

Ensuring quality oversight and quality assurance and quality by designactivities related to GCP/GCLParea

Providing quality guidance and support for GCP/GCLP and GPP-related activities within Sobi, including audits, inspections, and risk assessment of BLA/NDA/IND/CTA submissions under the global umbrella.

Support the collection of the data needed for Audit program risk assessment

Support clinical studies-related activitiesfrom a quality perspective across Sobi

Ensure qualification of global and local ESP, as applicable,in GCP-regulated areas per Sobi procedures

The employee will in this role work with relevant stakeholders across the Sobi organization.

Key responsibilities:

Ensure GCP audit management excellence of theend-to-endaudit management process and overview of the assigned audits, as planned

Assesand approve from quality perspective the GCP deviations (global and local, as applicable),GCPrelated CAPAs.

Prepare regular status report on performed audits, audittrending, deviationternding, CAPAstrending and agreed upon metrics to ensure Quality oversight.

Contributeandsupportthe GCP auditriskassesmentaccording to SOPs.

Ensureactive contribution in the cross-functional team with procurement, business owners forGxPand Quality requirements anddocumented qualification of GCP service providers and review provisionsin contracts/Quality agreements, as applicable

QA representativeduringGCPinspectionsglobal and sitelevel, as applicableand contribute to the Inspection Readiness framework and promote continuously quality mindset across Sobi.

Authoring GCP QA related processes, reviewand give guidanceunder global umbrella.

Required:

University degree orsimilarin Life Sciences or related discipline

5+ years of pharmaceutical industry experience in

Clinical Quality Assurance or in the operational conduct of clinical trials and the application of GCPaudit and/or Quality Assurance experience.

Technical skills:

Excellent knowhow of the applicable ICH GCP guidelines, industry best practices andFDA,EMAand ROWregulatory requirements.

Quality assurance activities principles andknow-how

Documented education/experience in QA systems and preferably auditing

Structured with focus on results and detail oriented

Strong interpersonal skills with communicative and flexible attitude

Proactive and collaborative mindset

Strong multi-tasking abilities with high resilienceat stressand adaptative skills

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-$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.

All Sobi employees need to demonstrate behaviors in line with Sobi's…