QA Manager, GCP

The QA Manager GCP is responsible for:  

• Ensuring quality oversight and quality assurance and quality by design activities related to GCP/GCLP area 

• Guide and support from a quality perspective the GCP/GCLP and GPP related activities within Sobi including audits inspection and support of and risk assessment of the BLA/NDA/IND/CTA submissions under global umbrella. 

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

• Support from quality perspective the clinical studies related activities across Sobi  

• Ensure qualification of global and local ESP as applicable in GCP regulated area per Sobi procedures 

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

Key responsibilities:

• Ensure GCP Audits 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.  

• At least 5 years experience from the pharmaceutical industry 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 

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-$153000. 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.

If you are a qualified individual with a disability or a disabled veteran you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to   

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Remote Work :

Yes

Employment Type :

Full-time