Global QA GVP Director / Manager - Oncopeptides

Global QA GVP Director / Manager - Oncopeptides

We are looking for a Global QA GVP Director/Manager for Oncopeptides. Oncopeptides is a global biotech company focused on the development of targeted therapies for difficult-to-treat hematological diseases. The Company has recently been granted accelerated approval by the U.S. The company, which is listed on the Stockholm Stock Exchange, was founded in Sweden year 2000 and operates globally.  

The company are now expanding the Global QA Group with a QA position within Good Pharmacovigilance Practice (GVP). The Global QA department at Oncopeptides consists of a group of QA experts with different expertise within GxP and a Process specialist. 

 

Responsibilities

  • Maintains a contemporary knowledge of current industry trends, standards, and methodologies as it relates to Good Pharmacovigilance Practice (GVP).
  • Collaborate with relevant functions within the company giving support and guidance within GVP.
  • Responsible for performing GVP quality assurance activities in accordance with GVP, applicable regulations and the company’s policies and procedures.
  • Responsible for accurately identifying and communicating compliance risks and overseeing action plans to mitigate risks.  
  • Participate in the implementation of IT systems related to the QMS.
  • Participate and/or lead domestic and international audits to ensure compliance to applicable regulations, and company standards.
  • Update and review of procedural documents related to Quality Systems such as Policies, SOPs and Work Instructions.
  • Review and approve third party vendor audit reports for content, format, regulatory risks. 
  • Contribute to the development and implementation of continuous quality improvement initiatives. 

Requirements

  • Bachelor’s degree in scientific or allied health field.
  • Minimum 2 years of QA GVP work experience.
  • You are an excellent verbal and written communicator in both Swedish and English. 
  • In depth knowledge of FDA regulations, EU Regulations and Directives, and GVP guidelines. 
  • In-depth knowledge and experience in PV Quality Assurance auditing and/or with relevant regulatory compliance /quality system, including quality system development.
  • Possess the necessary scientific education and knowledge to manage quality oversight for clinical trials. 
  • Demonstrate proficiency in managing complex projects, delivering all expected deliverables in a timely manner.
  • You are an excellent verbal and written communicator in both Swedish and English. 


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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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