Senior Manager (gn) Quality Assurance and Operations
- Work experience
- Quality Management, Quality Assurance
- Fulltime
- Unlimited
Our focus is on treatments in ophthalmology and immunology as well as for other key chronic diseases. Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines.
To support our Quality Assurance and Operations team in Martinsried near Munich, we are looking for suitable candidates for this full-time and permanent position, to begin work as soon as possible.
Your responsibilities
In this role you will act as Quality Management representative for assigned pharmaceutical development projects. This includes, but is not limited to the following tasks:
- Review and collaborate with external CDMOs to ensure successful product launch and market supply.
- Review of external quality-relevant pharmaceutical documents, such as development reports, batch records, testing and validation protocols.
- Participate in project meetings and ensure compliance with internal and external guidelines and standard operating procedures (SOPs), if applicable.
- Auditing of contract manufacturers and implementation of up-grade projects to achieve the necessary GMP standard.
- Processing and verification of external changes and deviations.
- Responsible for the drafting, negotiation and conclusion of quality agreements.
- Ensuring the qualification of external suppliers involved in the project(s).
- Guidance from colleagues on internal and general GMP requirements
The role also inlcudes general quality tasks such as:
- Continuous improvement of the quality management system (QMS), e.g. successful authority inspections and proactive suggestions for improvement.
- Development and execution of training courses.
- Processing of internal changes, deviations, corrective and preventive actions (CAPAs), trend and risk assessments.
Your qualifications
- Bachelor’s degree, ideally a higher degree in pharmacy, chemical engineering, biotechnology, or a related field
- At least 5 years of relevant experience in pharmaceutical QA and compliance
- Fluency in written and spoken English, good command of German
- Strong analytical, problem‑solving and critical‑thinking abilities
- Structured, independent and proactive working style
- Team-oriented mindset with strong communication and presentation skills
- Willingness to travel
What we offer
- Hybrid working model and flexible work arrangements
- 30 days of vacation plus additional days off on Christmas Eve and New Year’s Eve
- Formycon Mastercard and employer-supported pension scheme
- Comprehensive health & wellbeing offering, including occupational health services, fitness discounts, group accident insurance and mental health support
- Individual development and career paths, internal trainings and participation in conferences and scientific events
- A collaborative, inclusive culture with a strong focus on diversity, equal opportunity and respect in a modern working environment
Have we sparked your interest? Then we look forward to receiving your application through our online application portal!
We welcome applications from all people – regardless of gender, gender identity, sexual orientation, origin, religion/belief, disability, age or lifestyle.
Applicants with severe disabilities will be given preferential consideration in cases of equal suitability. Please note that our building is currently not fully wheelchair accessible. However, we warmly encourage you to contact us so that we can discuss and explore suitable solutions together to accommodate individual needs.
If you have any questions, please email us at recruiting@formycon.com.
Redaktionell empfohlener externer Inhalt
