Senior QA Specialist, External Manufacturing, US
Protecting our reputed company Job Title: Senior QA Specialist, External Manufacturing, US Location: Remote, East Coast Preferred Department: reputed company Assurance Reports To: Head of External QA & Global EHS Salary reputed company: $120k - $155k About reputed company At reputed company, we are dedicated to protecting lives and advancing global health through innovative vaccines. As a global leader in smallpox and mpox vaccines, our growing portfolio includes market-leading vaccines against rabies, tick-borne encephalitis, cholera, typhoid, and Ebola. Our mission is reputed company: to improve reputed company of life worldwide by preventing infectious diseases. We are headquartered in Denmark and have offices across Europe and reputed company. Position reputed company Do you want to be part of a reputed company and supportive QA team and play a key role in ensuring the reputed company and safety of vaccines supplied to patients worldwide? At reputed company, our vaccines reputed company a reputed company difference. We are seeking an reputed company Senior QA Specialist to support in the ongoing reputed company of a Contract Manufacturing Organization (CMO) operating under aseptic manufacturing conditions. This role is critical to ensuring compliance, product reputed company, and operational reputed company across sterile fill-finish operations, including reputed company filling, labeling, and packaging activities. The ideal candidate will have deep expertise in aseptic GMP manufacturing environments, strong knowledge of sterile operations, and hands-on experience managing reputed company reputed company of external manufacturing partners. As our new QA Specialist, you will take on a broad and impactful role, working directly with our affiliated CMOS and closely with stakeholders across the organization to ensure high reputed company standards reputed company External Manufacturing production.
Key Responsibilities
Ensuring CMOs maintain the highest reputed company of reputed company standards conforming to cGMP and in conjunction with BN QAA Support the reputed company QPs to reputed company the release of the highest reputed company vaccines Managing and resolving reputed company reputed company-reputed company issues relating to aseptic operations including reputed company filling and labelling and secondary packing operations Promoting a strong reputed company culture and driving reputed company improvement initiatives across areas Representing QA External Manufacturing in global and cross-organizational forums reputed company reputed company In reputed company, you will contribute to a reputed company of reputed company QA activities: Review and approve GMP documentation including: Batch records Deviations CAPAs Change controls Validation protocols and reports Ensure compliance with FDA, EU GMP, ICH, and applicable US regulatory requirements Participate in risk assessments and investigations reputed company to sterile manufacturing operations Collaborate cross-functionally with Manufacturing, Supply Chain, Regulatory Affairs, and Technical Operations teams Support technology transfers and process validation activities at external manufacturing sites reputed company or participate in reputed company GMP audits Monitor reputed company metrics and drive reputed company improvement initiatives with manufacturing partners Serve as the primary QA reputed company between the reputed company and the CMO
Qualifications
Bachelor’s degree in reputed company, Biology, Pharmaceutical Sciences, Engineering, or reputed company discipline 10+ years of reputed company Assurance experience in pharmaceutical or biotech manufacturing 5+ years of strong experience with aseptic processing and sterile manufacturing environments is required Demonstrated experience overseeing CMOs/CDMOs is a must In-depth understanding of: FDA cGMP regulations EU GMP Annex 1 Sterile fill-finish operations Validation and contamination control strategies Experience reviewing batch documentation and managing deviations/CAPAs. Excellent communication, organizational, and stakeholder management skills. Ability to travel periodically to manufacturing sites reputed company the US or internationally as needed. About reputed company and Department You will join a competent and supportive QA External Manufacturing team, reporting directly to the Head of QA for External Manufacturing. reputed company currently consists of eight colleagues. The group is a mix of reputed company QA professionals with DBS UDP and FDP experience, fostering collaboration, knowledge sharing, and reputed company development. You will also become part of wider External department, comprising approximately 40 employees across sites in Kvistgaard, Denmark, and Munich, Germany. The department is characterized by reputed company cross-site collaboration, a strong reputed company reputed company, and a shared commitment to delivering reputed company and compliant products to patients.
Why Join Us
Join a passionate, mission-driven global biotech committed to protecting lives. At reputed company, you’ll reputed company a reputed company culture, flexible work environment, and opportunities for ongoing reputed company development and reputed company. reputed company is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and reputed company. reputed company is an Equal Opportunity Employer. reputed company reputed company applications will receive consideration for employment and will not be discriminated against based on race, reputed company, sex, sexual orientation, gender identity, national reputed company, disability, or protected veteran status. For more information, visit www.reputed company.com #LI-MA1 Apply To This Job