Quality Assurance / Qualified Person (QP)

Position Summary:
Are you ready to ensure the highest standards of product quality in a global pharmaceutical environment? ALK is seeking a dedicated and detail-oriented Quality Assurance / Qualified Person (QP) to join our Quality team. In this vital role, you will be responsible for overseeing key Quality Assurance (QA) functions, ensuring that manufacturing and packaging operations—both in-house and at contract manufacturing organizations (CMOs)—comply with cGMP regulations. Your work will directly support our mission of delivering high-quality, life-saving treatments to patients worldwide.

This position combines hands-on batch record review and product release with strategic involvement in continuous improvement, training, audits, and global projects. If you are passionate about compliance, quality, and teamwork, we invite you to be part of our collaborative and purpose-driven organization.

Key Responsibilities:

• Batch Review & Release:
• Review batch records for completeness and accuracy
• Approve Master Batch Records for manufacturing and packaging
• Disposition and release products manufactured in-house or by third-party CMOs, including new product introductions
• Compliance & Quality Oversight:
• Participate in and support internal and external (supplier) GMP audits
• Support quality-related processes such as change control, deviations, CAPA, and customer complaints
• Support the preparation and approval of Product Quality Reviews (PQRs)
• Training & Support:
• Contribute to the execution and development of cGMP training programs
• Provide guidance and support to cross-functional teams in managing quality-impacting situations
• Participate in global quality initiatives and projects as needed

 Qualifications:

• Educational Background:
• University degree in Pharmacy (required)
• Advanced understanding of GMP regulations and pharmaceutical quality systems
• Professional Experience:
• Minimum 3 years’ experience in pharmaceutical or biotech industries
• Proven experience as a Qualified Person (QP)
• In-depth knowledge of EU GMPs, quality systems, and regulatory frameworks
• Technical & Language Skills:
• Proficient in Microsoft Office and SAP systems
• Fluent in English, both written and spoken
• Personal Attributes:
• Strong quality mindset and attention to detail
• Capable of detecting issues and driving continuous improvement
• Effective communication and leadership skills, especially in cross-cultural environments
• Resilient and comfortable managing complexity and ambiguity in a regulated setting

Why ALK?

• Global Impact: Play a key role in ensuring product quality for a global leader in allergen immunotherapy
• High-Standards Culture: Work in a company where quality is central to everything we do
• Collaborative Environment: Join a team of professionals passionate about patient safety and continuous improvement
• Professional Development: Opportunity to engage in global projects and expand your pharmaceutical quality expertise

Ready to Safeguard Patient Trust?
If you’re an experienced Qualified Person looking to make a meaningful impact in a patient-focused organization, apply now and become part of our mission at ALK.