Job Description
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
- 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 activities from 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 the end-to-end audit management process and overview of the assigned audits, as planned
- Asses and approve from quality perspective the GCP deviations (global and local, as applicable), GCP related CAPAs.
- Prepare regular status report on performed audits, audit trending, deviation ternding, CAPAs trending and agreed upon metrics to ensure Quality oversight.
- Contributeand support the GCP audit risk assesment 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 and review provisions in contracts/Quality agreements, as applicable
- QA representative during GCP inspections global and site level, as applicable and contribute to the Inspection Readiness framework and promote continuously quality mindset across Sobi.
- Authoring GCP QA related processes, review and give guidance under global umbrella.
Qualifications
Required:
- University degree or similar in 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 GCP audit and/or Quality Assurance experience. Technical skills:
- Excellent knowhow of the applicable ICH GCP guidelines, industry best practices and FDA, EMA and ROW regulatory requirements.
- Quality assurance activities principles and know-how
- Documented education/experience in QA systems and preferably auditing Soft skills:
- 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 resilience at stress and adaptative skills
Company Description
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. We look forward to hearing from you! 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