Senior Manager (gn) Quality Assurance and Operations

Senior Manager (gn) Quality Assurance and Operations

Senior Manager (gn) Quality Assurance and Operations

Beginn

Formycon is an international leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars.

With an experienced team comprised of around 200 highly skilled professionals, the company is able to span the entire value chain of biosimilar drug development, from market analysis and target definition by protein analytics, to the development of production processes, to clinical trials and the regulatory approval process.

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 upgrade 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 qualitymanagement 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

More details on our career page.

Bring us your skills and energy and shape your own career in a stimulating and open work environment. We are looking for highly motivated individuals who are ready to take on new challenges with enthusiasm and personal commitment. Working at Formycon means being part of a smart, innovative team with minimal hierarchy and opportunity to share your own ideas.

Please note that we do not accept applications or candidate profiles from recruitment agencies or headhunters for this position.

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.

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