Career

Head of Quality Assurance

Location:  Stockholm, Sweden

The role in general

The Head of QA will lead and build and support the quality system at OxThera. The role holder will also work hands-on with quality matters connected to the out-sourcing of manufacturing projects including reviewing quality assurance and quality control testing data to CMOs. He or she will also be responsible for and involved in audits and inspections of CROs and CMOs.

Key Responsibility Areas

  • Responsible for QA work in general at OxThera
  • Hands-on work with defining, setting up, implementing and maintaining  the Oxthera quality system
  • Provide QA review and approval as appropriate of internal and external (from CMO) quality documents
  • Ensure risk based audit strategy and that yearly audit programs are approved and executed
  • Review and approve audit responses and CAPAs
  • Coordinate or perform audits and ensure timely follow-up, escalate as needed
  • Train internal stakeholders in the quality system and regulatory requirements
  • Ensure that QA functions and procedures at CMOs are documented and followed for the drug supply
  • Sponsor release of Drug Product for the market

Education

  • Bachelor´s degree or higher in Life Sciences

Experiences

  • Minimum 10 years working experience in the pharmaceutical industry and minimum 5 years experience working with quality assurance and audits
  • Sound knowledge of regulatory requirements within GMP/GDP and experience of inspections
  • Experienced in managing Risk Assessments and yearly Audit Programs, managing Deviations and CAPAs and auditing Contract Manufacturing Organisations
  • Experienced in managing Deviations, CAPAs and Change Control

Skills and abilities

  • Excellent communication skills in Swedish and English and ability to communicate strategic direction of QA in relation to the regulatory environment
  • To be able to work in a complex environment and collaborate with many stake holders

More information and application

Please call Knut Natt och Dag on +46 722 166 800 if you have any questions. Apply by e-mailing your CV and a personal letter to knut.nattochdag@aktivia.se as soon as possible. We are working continuously with this recruitment project. Write “Head of Quality Assurance” in the subject field.

 


Medical / Regulatory Writer

Location:  Stockholm, Sweden

Position Summary

To review and interpret clinical data; to independently write, edit, review, QC and compile complex documents in a clear and accurate way; to manage medical writing tasks; to ensure the accuracy and quality of applicable written deliverables and their compliance with ethical, legal and regulatory standards.

Knowledge, Skills, and Abilities:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

  • Bachelor’s degree or local equivalent, preferably in a biomedical sciences, plus additional medical and/or relevant scientific education or experience. Advanced degree (Master’s, PhD, MD, or local equivalent) a strong plus.
  • A minimum of 3+ years’ experience in a pharmaceutical, biotech or CRO environment. (Ideally with experience of biologics).
  • Experience in nephrology and inborn errors of metabolism therapeutic areas would be an advantage.
  • Ability to work with complex projects, within cross-functional teams, and under tight timelines.
  • Ability to work efficiently without supervision.
  • Knowledge of clinical trial and drug development processes.
  • Knowledge of scientific and regulatory requirements, specifically protocols and clinical study reports.
  • Excellent written and verbal communication skills in English, data-interpretation skills, strong interpersonal skills, ability to plan and organize.
  • Excellent computer skills to include MS Word, MS Excel, MS PowerPoint, MS Outlook, and Adobe Acrobat.
  • Document organization, management, and version control skills to include hyperlinking, TOC generation, and field updating.

More information and application

Please call Rolf Carlsson on +46 703161268 if you have any questions. Apply by e-mailing your CV and a personal letter to rolf@haegerpartner.com or gunilla@haegerpartner.com as soon as possible. We are working continuously with this recruitment project. Write “Medical/Regulatory writer” in the subject field.