Clinical Quality Assurance Director

Vor 7 Tagen

Basel, Basel-Stadt, Schweiz TN Switzerland Vollzeit

Social networks and platforms you want to join:

Clinical Quality Assurance Manager - Investigational Medicinal Product (IMP), Basel Client:

Sobi

Location:

Basel, Switzerland or Stockholm, Sweden

Job Category:

Other

Job Reference:

92e5e2a7d4aa

Job Views:

4

About the role

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 cross-functional relationships with internal stakeholders.

  • Act as the primary quality liaison for external suppliers, organizing inquiries, investigations, and audit follow-ups.
  • 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 cross-functionally 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.

About you:

You are comfortable in a global and dynamic environment where priorities shift often and are a highly diplomatic and tactful individual with excellent critical reasoning, risk-analysis, and problem-solving skills. It is vital to have interpersonal and leadership skills with the ability to influence external suppliers and cross-functional teams to foster open and collaborative discussions around difficult decisions and impactful solutions.

About us:

We refuse to accept the status quo because we witness first-hand the challenges facing those affected by rare diseases and use this knowledge to shape our business to find new ways of helping them.

Key Qualifications:

  • Bachelor's degree or equivalent education/degree in life sciences.
  • Solid understanding of GMP & GDP and GCP requirements in support of IMP study.
  • Minimum of 10 years of experience within the pharmaceutical or biotech industry.
  • Relevant experience 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.

How to apply:

We invite you to send your application including your resume in English. We look forward to receiving your application and exploring how you can contribute to our team.

Why Join Us?

  • Emphasis on work/life balance.
  • Collaborative and team-oriented environment.
  • Opportunities for professional growth.
  • Diversity and Inclusion.
  • Competitive compensation for your work.
  • Making a positive impact to help ultra-rare disease patients who need life-saving treatments.

  • Associate Director, Quality Assurance and Regulatory Compliance

    Vor 2 Tagen

    Basel, Basel-Stadt, Schweiz TN Switzerland Vollzeit

    TN Switzerland is seeking an experienced Associate Director, Quality Assurance and Regulatory Compliance to join our team. This is a key role that requires strong leadership and collaboration skills, as well as extensive experience in GCP auditing, vendor management, and quality assurance.About the RoleThe successful candidate will be responsible for...

  • Quality Assurance Professional

    Vor 3 Tagen

    Basel, Basel-Stadt, Schweiz TN Switzerland Vollzeit

    TN Switzerland is seeking a highly skilled Quality Assurance Professional to join our team in Basel. As a key member of our IMP Quality Clinical Packaging department, you will be responsible for ensuring the quality and compliance of all manufacturing units and clinical packaging processes.Our company is committed to transforming itself into a purpose-driven...

  • Quality Assurance Specialist

    vor 5 Stunden

    Basel, Basel-Stadt, Schweiz ITech Consult AG Vollzeit

    Job DescriptionWe are seeking a highly motivated and experienced Quality Assurance Specialist to join our team in Switzerland. As a key member of the Clinical Packaging Team, you will be responsible for ensuring the quality of Investigational Medicinal Products (IMPs) in compliance with cGMP regulations.Key Responsibilities:Support packaging operations and...

  • Quality Assurance Specialist

    Vor 3 Tagen

    Basel, Basel-Stadt, Schweiz TN Switzerland Vollzeit

    **Job Overview:**TN Switzerland is seeking a highly motivated and experienced individual to join our team as an IMP Quality Clinical Packaging specialist.The ideal candidate will have a strong background in quality assurance, clinical packaging, and investigational medicinal products.Support all quality-relevant packaging processes and collaborate with...

  • Senior Quality Assurance Manager

    Vor 2 Tagen

    Basel, Basel-Stadt, Schweiz TN Switzerland Vollzeit

    At TN Switzerland, we are committed to the highest standards of quality and compliance in our clinical trials. We seek a highly experienced and skilled Senior Quality Assurance Manager to join our team and lead our vendor management and GCP audit activities.About the RoleThis is a senior role responsible for leading the strategy, execution, and oversight of...

  • Quality Assurance Packaging Expert

    vor 7 Stunden

    Basel, Basel-Stadt, Schweiz JobCourier Vollzeit

    About the PositionWe are looking for a highly skilled Quality Assurance Packaging Expert to join our team at JobCourier. As a Quality Assurance Packaging Expert, you will be responsible for ensuring the quality of packaging processes and materials used in the production of pharmaceutical products.The ideal candidate will have a minimum Master's degree in...

  • Clinical Operations Manager

    Vor 4 Tagen

    Basel, Basel-Stadt, Schweiz TN Switzerland Vollzeit

    Who We Are:Aixial Group is a leading provider of clinical research services to the Life Science industry.We deliver high-quality solutions across the entire value chain, from phase I to post-market surveillance.Our team consists of experts with extensive experience in clinical operations, regulatory affairs, and quality management.Clinical project...

  • IMP Quality Clinical Packaging

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Work Selection AG Vollzeit

    Work Selection AGWe are looking for a motivated and committed IMP Quality Clinical Packaging for our client, F. Hoffmann-La Roche Ltd. based in Basel, for a 18 month assignment.IMP Quality Operations Switzerland is responsible for delivering Investigational Medicinal Products (?IMPs?) to our patients in compliance with cGMP. We are the Quality Partner for...

  • Quality Assurance Specialist

    vor 14 Stunden

    Basel, Basel-Stadt, Schweiz talendo AG Vollzeit

    About the RoleTalendo AG is looking for a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring that our clients' quality management systems are compliant with regulatory requirements.Key Responsibilities:Provide QA oversight for GCP / PV / GLP activities within the company and at vendor /...

  • Pharmaceutical Quality Clinical Supervisor

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Randstad (Schweiz) AG Vollzeit

    Role OverviewWe are seeking a Quality Clinical Packaging Specialist to support the end-to-end cGMP activities, maintaining the Right to Operate at the Clinical Packaging Site in Kaiseraugst.Key ResponsibilitiesPackaging Operations: Partner with stakeholders to provide GMP support ensuring successful delivery of company goals.Quality Control: Review and...

  • Clinical Operations Specialist

    Vor 3 Tagen

    Basel, Basel-Stadt, Schweiz TN Switzerland Vollzeit

    TN Switzerland is seeking a highly skilled Clinical Operations Specialist to join our team in Basel. As a key member of our IMP Quality Clinical Packaging department, you will be responsible for ensuring the quality and compliance of all manufacturing units and clinical packaging processes.Our company is committed to transforming itself into a purpose-driven...

  • Quality Assurance Manager for Pharmaceutical Development

    vor 1 Tag

    Basel, Basel-Stadt, Schweiz Work Selection AG Vollzeit

    We are seeking a Quality Assurance Manager to join our team at Work Selection AG. The successful candidate will be responsible for ensuring quality and compliance of Investigational Medicinal Products (IMPs) manufactured and packed for clinical studies in Switzerland.ResponsibilitiesQA supervision of qualification- and validation-activities for GMP-relevant...

  • Clinical Packaging Manager

    Vor 3 Tagen

    Basel, Basel-Stadt, Schweiz TN Switzerland Vollzeit

    **Job Description:**TN Switzerland is seeking a highly skilled individual to join our team as an IMP Quality Clinical Packaging specialist.The successful candidate will be responsible for supporting all quality-relevant packaging processes and collaborating with packaging operations and all relevant interfaces with regard to GMP topics.Candidates should have...

  • Quality Assurance Specialist

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz ITech Consult AG Vollzeit

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our IT department, you will be responsible for planning and executing migrations and rollouts of Windows clients and servers in the laboratory and manufacturing environment.Key ResponsibilitiesCollaborate with other IT team members to ensure...

  • Quality Assurance Specialist

    Vor 3 Tagen

    Basel, Basel-Stadt, Schweiz jobtome-all Vollzeit

    Job Description:We are seeking a highly skilled Quality Assurance Specialist to join our Global Group Quality team. As a key member of the team, you will be responsible for qualifying and periodically re-evaluating supply chains of critical materials, contract laboratories, and service providers for GMP API manufacture and release.Responsibilities:Qualify...

  • Quality Assurance Manager

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

    For our client's company in Basel, we are looking for aQuality Assurance Manager- You review and approve SOP's, protocols, reports, Certificate of Analysis and other quality-related documents- You have a high sense of detail orientation and support investigations of deviations and out of specifications (OOS)- You maintain, record and process corrective and...

  • Quality Assurance Manager

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

    For our client's company in Basel, we are looking for aQuality Assurance Manager- You review and approve SOP's, protocols, reports, Certificate of Analysis and other quality-related documents- You have a high sense of detail orientation and support investigations of deviations and out of specifications (OOS)- You maintain, record and process corrective and...

  • Quality Assurance Manager

    Vor 5 Tagen

    Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

    We are seeking a highly skilled Quality Assurance Manager to join our team at Gi Group SA in Basel.The successful candidate will be responsible for reviewing and approving Standard Operating Procedures (SOPs), protocols, reports, Certificate of Analysis, and other quality-related documents.About the RoleThis is a challenging opportunity for a detail-oriented...

  • Packaging Quality Assurance Specialist

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Randstad (Schweiz) AG Vollzeit

    About UsRandstad (Schweiz) AG is a leading international Pharmaceutical company seeking an experienced professional to join our team as a Quality Clinical Packaging Specialist.Job DescriptionWe are looking for a highly skilled and motivated individual to support all quality-relevant packaging processes. The ideal candidate will have a strong background in...

  • Clinical Operations Director

    vor 1 Tag

    Basel, Basel-Stadt, Schweiz Roche Vollzeit

    At Roche, we're committed to pushing the boundaries of healthcare. As a global leader in research-focused healthcare groups, our success is built on innovation, curiosity, and diversity.The Head of Global Clinical Operations plays a critical role in delivering exceptional patient outcomes through innovative clinical trials. This strategic leader will oversee...