CMO Quality Manager (m/w/d)

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CMO Quality Manager (m/w/d)

CROMA-PHARMA is an internationally active, family-owned pharmaceutical Company with its headquarter in Leobendorf, Korneuburg district, in the north of Vienna. Many years of experience in the manufacturing of products based on hyaluronic acid and a unique level of expertise in the field of aesthetic medicine have made CROMA-PHARMA a globally renowned specialist in the dynamic and versatile business of anti-aging.
We are searching for applicants who want to make a sustainable contribution to our success as a family- run Austrian company.

We are expanding our Quality department and therefore looking for a/ an Quality Specialist for external manufacturing.

Ihre Aufgaben

  • Responsible for managing the relationship with assigned contract manufacturing organizations (CMOs) from a Quality perspective to ensure CROMA's product quality and reputation is protected
  • Support interface function between Contract Manufacturers (CMOs) and CROMA internal departments
  • Support establishing and maintaining strong relationships with CMOs and internal peers to develop and deliver shared objectives
  • Provide operational expertise to support transfer of all relevant aspects of the product specification to the CMOs
  • Contribute and ensure the qualitative requirements for product and production at the contract manufacturer are met
  • Support development, maintenance and communication of suitable KPI dashboards to measure CMOs / CROMA performance ensuring business and patient supply and quality needs are achieved.
  • Participate in the continuous monitoring of contract manufacturers on the basis of KPIs
  • Support and ensure timely escalation of issues and risks as relevant to appropriate stakeholders
  • Participation and analysis of CMOs in the context of the troubleshooting processes
  • Support operational issues are effectively resolved and that supply risks are being proactively managed
  • Review Quality documents and data ensuring compliance to GxP. Documents to include batch records, analytical data, logs, and others.
  • Maintain Quality documents such as SOPs, protocols, and others to ensure compliance with process and GMPs.
  • Review and apply release requirements to product, process intermediates, raw mate
  • Contribute for corrective and preventive actions for the further development of the product and the process maturity
  • Contribute for the complaint handling and relevant root cause investigation
  • Contribute for the product,- process,- system audits
  • Support business objectives and manufacturing, supply and quality deliverables are met by CMOs
  • Support identification and implementation of continuous improvement initiatives within the External Manufacturing & Operations team

Ihr Profil

  • Minimum of 8-10 years' experience in various Operations and Quality Assurance roles
  • Breadth of knowledge and experience applying Medical devices and GMP regulations/guidance's with the ability to interpret those
  • Demonstrated operational exposure
  • Technically versed
  • Demonstrated sense of urgency, to streamline the investigations including all necessary information to support decisions on batch disposal.
  • Demonstrated sound decision-making process; based on facts & data, and application of Risk Management principles.
  • Demonstrated ability to work and collaborate in cross-functional teams.
  • Excellent verbal and written communication skills in English;
  • Demonstrated intercultural skills. Capability to work with diverse and wide spread team.
  • Demonstrated quality acumen to effectively work with external companies
  • Experience of developing operational KPI dashboards and ability to interpret the data
  • identifying improvement opportunities
  • Minimum BS degree in a Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field. Advanced degree would be an advantage.

Wir bieten

We offer a varied work in a rapidly expanding company with diverse development opportunities and company benefits, as well as flexible working hours and home office. If you want to become part of a dynamic team, we look forward to meeting you!

For this position, a salary of EUR 53,000, - (full-time) applies gross p. a. Willingness to overpayment exists and depends on the specific qualification and experience.

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