VP Quality Assurance (QA) GxP - To Calliditas Therapeutics, Stockholm

VP Quality Assurance (QA) GxP - To Calliditas Therapeutics, Stockholm

We are looking for a Vice President Quality Assurance GxP to Calliditas Therapeutics. Calliditas is a specialty pharmaceutical company based in Stockholm, Sweden focused on identifying, developing, and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. The company was founded in 2004 and is publicly listed on both Nasdaq Stockholm and Nasdaq New York. 

The VP QA is overall responsible for ensuring adequate quality assurance activities within all GxP at Calliditas Therapeutics. The expert role is mainly within Good Clinical Practice (GCP) however the responsibility in the role includes coordination and overall management of all GxP activities and to include all these activities in the company audit plan. The role is strategic, global and reports to the CEO. The VP Quality Assurence is also a part of the Executive Team.

Responsibilities

  • Develop and maintain the QA department at Calliditas.
  • Line management of staff and consultants reporting to VP QA.
  • Lead team members, including performance planning and staff development.
  • Take an active role as an Executive team member to ensure development and delivery of defined targets and initiatives in line with the strategy.
  • Responsible for QA budget.
  • Ensure there is a robust Quality Management System in place in order to fulfill regulatory requirements for clinical trials.
  • Responsible for managing/coordinating regulatory inspections related to Calliditas studies.
  • Responsible for developing strategic audit plans within all GxP’s.
  • Ensure audits are conducted in accordance with the plan, ensure adequate CAPA’s are developed by the auditees in accordance with company SOPs.
  • Ensure adequate audit capacities are contracted to fulfill the audit program.
  • Ensure appropriate evaluation of CROs and third-party vendors.


Requirements

  • Master’s degree in Scientific or allied health field.
  • 5 years of relevant clinical trial experience, and 10 years of relevant QA experience.
  • Broad knowledge of clinical processes, procedures and electronic management systems.
  • In-depth knowledge of FDA regulations, EU regulations and Directives, MHRA statutory Instruments and ICH GCP guidelines.
  • Experience from creating / managing quality systems.
  • Leadership / management experience.
  • Experience from FDA and EMA inspections is required.
  • Demonstrate proficiency in managing complex projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines. 
  • You are an excellent verbal and written communicator in both Swedish and English. 



Welcome to apply through: www.haegercarlsson.com
 

Questions are answered by Gunilla Haeger +46 (0)70 – 461 93 87, gunilla@haegercarlsson.com or 

Anna Wikman +46(0)73-539 33 87, anna@haegercarlsson.com

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