Copy of Clinical Quality Assurance Manager - Investigational Medicinal Product IMP
Copy of Clinical Quality Assurance Manager - Investigational Medicinal Product IMP
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Job Description
About the role
As the Clinical Quality Manager you will play a pivotal role in ensuring the quality and compliance of Investigational Medicinal Products (IMPs) through your leadership and guidance of supplier management teams. Acting as the single point of contact for external suppliers you will oversee manufacturing quality ensure adherence to GMP & GDP regulations and build strong crossfunctional relationships with internal stakeholders.
The role is located at the global Sobi HQ in Stockholm Sweden or in Basel Switzerland.
Key Responsibilities
- Act as the primary quality liaison for external suppliers organizing inquiries investigations and audit followups.
- Maintain oversight of quality topics for Sobi IMPs across markets
- Continuously improve work processes related to quality and compliance of IMPs
- Oversee batch record reviews and release for IMPs across US EU and RoW clinical trials.
- Monitor and manage key performance indicators (KPIs) related to IMP supplier quality.
- Ensure compliance with Quality Agreements and support revisions in collaboration with internal teams.
- Work crossfunctionally with R&D GCP/GVP QA QA Supplier Managers and Product Quality Leads to address and escalate IMP quality issues.
- Support supplier audits and ensure readiness for Health Authority GMP inspections.
Qualifications :
About you
You are comfortable in a global and dynamic environment where priorities shift often and a highly diplomatic and tactful individual with excellent critical reasoning riskanalysis and problemsolving skills. Is it vital to have interpersonal and leadership skills with the ability to influence external suppliers and crossfunctional teams to foster open and collaborative discussions around difficult decisions and impactful solutions.
Key Qualifications
- Bachelors degree or equivalent education/degree in life sciences.
- Have a solid understanding of the GMP & GDP and GCP requirements in support of IMP study.
- Minimum (10) years of experience within pharmaceutical biotech product.
- Relevant experience from working with quality aspects of medicinal products in clinical trials especially batch allocation and supply to clinical trials
- Extensive experience in QA operation production or other relevant area (GMP GDP)
- Strong working knowledge of US and European regulations with emphasis on Annex 13 and preferably other regions such as APAC and LATAM.
- Strong understanding of risk assessment and risk management fundamentals / tools
- Fluently spoken and written English
Here at Sobi we live by our core values: Care Ambition Urgency Ownership and Partnership!
Additional Information :
How to apply
We have an ongoing selection process in this recruitment and ask you to send your application as soon as possible. Click apply and include your resume in English.
Why Join Us
Here at Sobi our mission and culture get us excited to come to work every day but here are a few more reasons to join our team:
- Emphasis on work/life balance
- Collaborative and teamoriented environment
- Opportunities for professional growth
- Diversity and Inclusion
- Competitive compensation for your work
- Making a positive impact to help ultrarare disease patients who are in need of life saving treatments
Sobi is a global company with over 1800 employees in more than 30 countries and are committed to the societies where we operate. We are a specialised international biopharmaceutical company transforming the lives of people with rare and debilitating diseases providing reliable access to innovative medicines in the areas of haematology immunology and specialty care. Sobis share is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.
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 firsthand 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 groundbreaking treatments we help make medicine more accessible and open 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.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
