About the Role:We are seeking a Senior QA Specialist to join ALK-Abelló at a pivotal time in our operations. This role will focus on overseeing quality assurance functions at our Contract Manufacturing Operations (CMO), ensuring compliance with company expectations and regulatory requirements. You will play a key role in driving continuous improvement in quality assurance practices and ensuring high standards are implemented across all processes.Key Responsibilities:Perform Quality Assurance activities associated with maintaining internal Quality Systems, including Change Control, Deviations, CAPA, and more.Review GMP technical and validation reports for:Manufacturing and packaging processes.Cleaning Validation/Equipment cleaning procedures.Laboratory and manufacturing equipment qualification.Facilities and utilities with product contact.Analytical methods validation.Provide quality support for technology transfer projects.Offer on-site guidance in preparing procedures and working instructions.Resolve GMP issues by identifying problem areas, refining systems, and training/coaching relevant personnel.Maintain permanent inspection readiness status.Provide QA support for regulatory filings.Prepare documentation for Material Review Board presentations and meetings.Support QA Management as required.Offer GMP quality expertise, advice, and assistance across the organization as needed.Required Qualifications and Skills:Minimum of 5 years' experience in the pharmaceutical/biotech industry, with a thorough knowledge of quality systems, GMP, and regulatory requirements.University degree in Chemistry, Pharmacy, Biology, or equivalent.Essential skills: Fluent in both written and spoken English and Spanish.Thorough knowledge of oral solid forms and technology transfer projects.Knowledge of sterile products regulation is a plus.Expertise in interdisciplinary areas such as pharmaceutical sciences, analytical chemistry, microbiology, cGMPs, regulatory issues, and data integrity regulation.Strong interpersonal and leadership skills, capable of handling organizational complexity and ambiguity, particularly in stressful situations.What We Offer:A key role within an international organization with the opportunity to make impactful contributions to quality assurance practices.Competitive salary and benefits package.Professional growth within a dynamic, collaborative team.Interested?If you’re passionate about ensuring high-quality standards and driving continuous improvement in the pharmaceutical industry, apply today to join our team at ALK-Abelló!About the Role:We are seeking a Senior QA Specialist to join ALK-Abelló at a pivotal time in our operations. This role will focus on overseeing quality assurance functions at our Contract Manufacturing Operations (CMO), ensuring compliance with company expectations and regulatory requirements. You will play a key role in driving continuous improvement in quality assurance practices and ensuring high standards are implemented across all processes.Key Responsibilities:Perform Quality Assurance activities associated with maintaining internal Quality Systems, including Change Control, Deviations, CAPA, and more.Review GMP technical and validation reports for:Manufacturing and packaging processes.Cleaning Validation/Equipment cleaning procedures.Laboratory and manufacturing equipment qualification.Facilities and utilities with product contact.Analytical methods validation.Provide quality support for technology transfer projects.Offer on-site guidance in preparing procedures and working instructions.Resolve GMP issues by identifying problem areas, refining systems, and training/coaching relevant personnel.Maintain permanent inspection readiness status.Provide QA support for regulatory filings.Prepare documentation for Material Review Board presentations and meetings.Support QA Management as required.Offer GMP quality expertise, advice, and assistance across the organization as needed.Required Qualifications and Skills:Minimum of 5 years' experience in the pharmaceutical/biotech industry, with a thorough knowledge of quality systems, GMP, and regulatory requirements.University degree in Chemistry, Pharmacy, Biology, or equivalent.Essential skills: Fluent in both written and spoken English and Spanish.Thorough knowledge of oral solid forms and technology transfer projects.Knowledge of sterile products regulation is a plus.Expertise in interdisciplinary areas such as pharmaceutical sciences, analytical chemistry, microbiology, cGMPs, regulatory issues, and data integrity regulation.Strong interpersonal and leadership skills, capable of handling organizational complexity and ambiguity, particularly in stressful situations.What We Offer:A key role within an international organization with the opportunity to make impactful contributions to quality assurance practices.Competitive salary and benefits package.Professional growth within a dynamic, collaborative team.Interested?If you’re passionate about ensuring high-quality standards and driving continuous improvement in the pharmaceutical industry, apply today to join our team at ALK-Abelló!ALK helps people living with allergy. By providing solutions that make life with allergy surprisingly simple we make a difference for many people. We build upon a strong heritage as a pioneer in allergy immunotherapy and we will continue to innovate, develop and market new products and solutions for people with allergy. ALK is a global company with production sites in Denmark, France, Spain and the United States. We were founded in Copenhagen in 1923. Headquartered in Hørsholm, Denmark, ALK employs around 2,900 people worldwide and is listed on Nasdaq Copenhagen.We know that our employees are our most valuable asset and we believe they do their very best every day in the pursuit of new and better allergy treatments and solutions for people with allergy around the world. If you like to have influence and make a difference ALK is the right place so come join us on our exciting journey.ALK helps people living with allergy. By providing solutions that make life with allergy surprisingly simple we make a difference for many people. We build upon a strong heritage as a pioneer in allergy immunotherapy and we will continue to innovate, develop and market new products and solutions for people with allergy. ALK is a global company with production sites in Denmark, France, Spain and the United States. We were founded in Copenhagen in 1923. Headquartered in Hørsholm, Denmark, ALK employs around 2,900 people worldwide and is listed on Nasdaq Copenhagen.We know that our employees are our most valuable asset and we believe they do their very best every day in the pursuit of new and better allergy treatments and solutions for people with allergy around the world. If you like to have influence and make a difference ALK is the right place so come join us on our exciting journey.