Senior Quality & Compliance Manager

Posted 14 Days Ago
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Basel, Basel-Stadt
Senior level
Other
The Role
The Senior Quality & Compliance Manager is responsible for overseeing the technical compliance with Swiss regulations concerning medicinal products and providing strategic and operational support in Quality Assurance for Veristat and its clients. They may also serve as a Responsible Person or Deputy for select clients.
Summary Generated by Built In

Job Description:

Senior Quality & Compliance Manager

 The main purpose of the position is to fulfil the technical responsibilities of the Swiss Responsible Person (RP, Fachtechnisch verantwortliche Person), according to articles 11, 13, 17 and 18 of the Swiss Medicinal Products Licensing Ordinance in relation to the Swiss Establishment License for import including market release of medicinal products.

The function holder also provides strategic and operational support in the field of Quality Assurance (QA) for Veristat and Veristat Clients and acts as Swiss RP or Deputy Responsible Person (DRP) on a mandate basis for selected clients, in relation to their Swiss Establishment Licenses.

What we do

For 30 years, Veristat has built a reputation as global experts in clinical development.

  • 760+ Rare Disease Clinical Trials supported
  • 160+ Marketing Applications supported
  • In 2022 we supported 8 marketing application that received regulatory approval
  • Learn more about our core values here!

What we offer

  • A stimulating role in an international and dynamic work environment
  • Continuous development and training opportunities
  • Office or Home-Based working
  • Rewards for outstanding accomplishments

What we look for

According to the Swiss Ordinance on Establishment Licences (SR 812.212.1), the RP (and Deputy):

  • Must hold a degree in pharmacy and the necessary experience in the manufacture of ready to-use medicinal products or possesses other professional qualifications which demonstrate sufficient knowledge and experience in the medicinal product sector.
  • Has knowledge of medicinal product legislation and guidance, in particular the international provisions of GMP and GDP.
  • Excellent knowledge of written and spoken English and a good working knowledge of a Swiss national language.

Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.

Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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The Company
Basel
443 Employees
On-site Workplace

What We Do

Veristat is the science-first full-service drug and biologic CRO and consultancy that integrates strategic planning, regulatory expertise, and clinical trial execution to rapidly advance the most complex or novel therapies.

At Veristat, we collaborate with clients to support the rapid delivery of life-changing therapies, helping them make sound decisions amidst uncertainties. Our scientific experts design and conduct the global activities required for any clinical, regulatory, or commercialization program comprehensively and efficiently. ​

With our focus on novel drug development and nearly 30 years of experience, our versatile approach and bold scientific thinking make the impossible possible. Depend on our game-changing expertise and reliable execution for fast results and positive impact to support your biologics and drugs to treat rare cancers, CNS/Neurological disorders, Endocrine/metabolic disorders, and infectious diseases.

We are…Bold. Scientific. Versatile. Veristat.​

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Veristat has recently been made aware that unknown third parties that have no connection to Veristat are generating fake Veristat job postings, interviews, and even fake employment offers via emails, websites, and various social media platforms, seemingly for the purpose of fraudulently obtaining personal information from legitimate job candidates. All legitimate correspondence from Veristat will originate from our applicant tracking system (Jobvite) or an @veristat.com email address. If you have received outreach from someone claiming to be a member of our team please search our official LinkedIn company page (https://www.linkedin.com/company/veristat-llc), where all members of our authorized recruiting team can be identified, or contact us directly at [email protected]. Be vigilant

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