Senior Specialist Method Lifecycle & QC Pharma Compliance

Join our diverse and highly experienced Method Lifecycle & QC Pharma Compliance (MLPC) team which supports analytical and microbiological organizations across addition to local activities the team is responsible for several global processes. A key focus of the team is supporting the Quality Service in Budapest through the development optimization and validation of analytical and microbiological methods new product implementation quality documentation direct collaboration with CMOs as well as regulatory and customer communication.
As a Senior Specialist - Method Lifecycle & QC Pharma Compliance you will contribute your expert knowledge to complex analytical and quality-related activities global processes and cross-functional projects. You will play a key role in supporting method transfers and validation/verification activities (participation in technology transfer projects) direct communication with CMOs driving continuous improvement and collaborating with colleagues and stakeholders across Xellia.

Main Responsibilities

• Contribute to new product implementation activities and QSB-related change control processes.
• Support Regulatory Affairs and Business Operations by providing expert input on analytical and quality-related questions.
• Lead oversee and coordinate the monitoring and reporting of compendial and pharmacopoeial updates and reviews across Xellia globally.
• Take responsibility for method related activities including the adaptation of pharmacopoeial methods and the optimization validation and/or transfer of new analytical methods for testing APIs and final dosage forms.
• Participate in the preparation of method transfer and verification/validation documentation including protocols and reports.
• Act as a key contact for other Xellia sites regarding method transfers and other method related quality activities.
• Communicate directly with and represent the company towards CMO partners and strategic external partners.
• Contribute to the resolution of complex global analytical and quality-related issues and communicate critical or complex results to relevant stakeholders.
• Provide expert guidance in laboratory deviation and OOS investigations related to transfer validation and verification activities.
• Manage QC laboratory-related projects and activities in collaboration with other departments across the organization.
• Initiate and propose changes to improve laboratory efficiency optimize workflows and strengthen GMP compliance.
• Contribute to the development implementation and operation of global analytical and quality processes.
• Provide coaching training mentoring and professional development support to experienced colleagues across different teams and functions.

What We Expect

• Minimum 10 years of experience in analytical chemistry or a related pharmaceutical analytical environment.
• Expert-level specialized knowledge in analytical methods and pharmaceutical quality control.
• Strong experience in method transfers validation verification.
• Excellent communication and stakeholder management skills with the ability to collaborate effectively across functions sites and cultures.
• Advanced proficiency in English both written and spoken.
• A proactive solution-oriented mindset and the ability to work independently on complex topics.
• The ability and willingness to share expertise coach others and contribute to the development of global processes and best practices.

What We Offer

• Competitive compensation and benefit package
• Nordic-style culture dynamic teamwork good working atmosphere flexibility maintaining work-life balance
• Opportunity to learn and develop
• Good team spirit and friendly colleagues
• Stable international company background
• Multinational working environment
• Home Office opportunity

Xellia Pharmaceuticals is the global leader in fermentation-based non-beta-lactam anti-infectives supplying Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs) to over 500 pharmaceutical companies across 80 countries.

Recognized by the World Health Organization and the European Union for our critical medicines we play a vital role in combating severe infections and antimicrobial resistance. Headquartered in Denmark we operate manufacturing sites in Copenhagen Denmark; Budapest Hungary; and Taizhou China with R&D and commercial operations in seven additional locations globally. As the only European manufacturer of several key anti-infectives and with a heritage spanning over 120 years we are driven by purpose and progress.

With more than 1100 employees our impact starts from within. We offer a workplace where ideas curiosity and initiative thrive and where your role evolves with your ambition. Instead of rigid structures we provide real responsibility freedom to explore and support to grow. Together we shape not only the future of our company and the development of our people but also the health of communities worldwide.

Further information aboutXellia can be found at:
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