Senior Manager – Project and Quality Management (m/f/d)

OncoOne is a biotech startup dedicated to developing innovative therapeutics to treat patients with solid tumors and chronic inflammation. OncoOne is an equal opportunity employer that maintains a diverse and inclusive work culture.
We are currently looking for highly motivated and creative Project and Quality Manager to lead quality management efforts and to assist in the development of antibody-based therapeutics at our offices and laboratories at Karl Farkas-Gasse 22, Vienna.

Duties and responsibilities:

  • Provide program management to cross-functional teams to support multiple research and development pipeline projects
  • Develop and manage detailed project schedules and work plans. Control of timelines, budget and deliverables according to program priorities.
  • Identify, mitigate, and communicate program risks to relevant stakeholders
  • Utilize industry best practices, techniques, and standards throughout entire project execution
  • Establish and maintain a Pharmaceutical Quality Management (QM) System appropriate for a preclinical and early-stage clinical biotech company
  • Draft, review and approve QM documents incl. Standard Operating Procedures
  • Overall responsibility for QM systems (deviations, OOS, change control, complaints and recalls, PQRs, audit planning, etc.)
  • Provide quality oversight of GxP relevant activities at CRO/CMO partners, including qualification/validation and execution of methods, processes, and studies. Maintain effective working relationship with CRO/CMO partners
  • Contribute to filing regulatory documents by writing and reviewing technical reports and CMC sections
  • Support meetings with management, Scientific Advisory Board, investors, and other stakeholders

Required qualifications:

  • Master’s degree or higher in life science with strong background in biotechnology or pharmaceutical development
  • Three or more years of professional experience in biotech or pharmaceutical industry mandatory within a quality related position
  • Certification as a quality auditor and/or qualified person is preferred
  • In-depth knowledge of GxP requirements (specifically in the field of GMP, GLP, GCP) as well as other regulations relevant for pharmaceuticals
  • Strong project management skills
  • Track record of drug development in pharma or biotech
  • Ability to influence and negotiate in a matrix environment to optimize development processes and address challenges and risks
  • Proactive management skills and ability to work with research organization, preclinical team and CROs/CMOs
  • Well-organized and self-reliant
  • Excellent team spirit, communication, and presentation skills
  • Fluency in English
  • Relevant computer skills

Compensation:

For the position we offer a minimum annual gross salary of EUR 65.000,-. The actual remuneration package will be based on your professional experience, qualification and skills. Increased pay is possible.

To apply:

Please send your cover letter and resume to office@oncoone.com

We look forward to receiving your application!