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.
- 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
- 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.
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.