QA Deviation & Complaint Manager (m/w/d)

Inossia is now recruiting a Quality Assurance (QA) Manager to the company. The position is full-time and based in our headquartered office in Stockholm and we are looking for a new colleague to join the team at Inossia. Inossia aims at improving fracture treatment for osteoporotic patients so that they can live an active life. Inossia® provides vertebral augmentation solutions that have been adapted to the mechanical properties of bone that will give Better fracture treatment for Osteporotic Bone. The company is entering a pivotal phase of its growth, with the upcoming launch of its first product and the transition from development to commercial operations. While moving toward market introduction, the company remains committed to ongoing research and development to advance solutions in spine care As a QA Manager, you will be responsible for managing our QMS and overseeing product releases. You will lead training on new SOPs and collaborate closely with our Production Manager to ensure accurate and compliant documentation. Additionally, your responsibilities will include preparing the organization for audits and conducting supplier audits. At Inossia, you will get the unique opportunity to build, shape and optimize our processes from the inside out, make a positive impact and apply your experience and expertise within QA to ensure the highest quality standards. If this sounds interesting to you - Come join us and be part of our mission of improving fracture treatment for osteoporotic patients so that they can live an active life. We will interview candidates continuously and welcome your application today! Responsibilities The QA Manager will have a central role in oversight and management of manufacturing and analytical activities from a quality perspective. You will report directly to the Director of QA/RA at Inossia. Your main responsibilities will include: Lead, maintain, and continuously improve the Quality Management System in accordance with ISO 13485 and applicable medical device regulations Ensure compliance throughout the medical device product lifecycle, from development and design through manufacturing, release, and post-market activities Oversee risk management activities, including risk files, benefit-risk analysis, and lifecycle updates Plan, conduct, and support internal and external audits, including notified body, supplier, and regulatory audits Act as a key point of contact for audit readiness, responses, and corrective actions Manage CAPA, non-conformances, deviations, and change control processes Collaborate cross-functionally to ensure quality is embedded across the organisation Support supplier quality management, qualification, and ongoing performance monitoring Ensure robust documentation control, version management, and data integrity Contribute to key strategic developments within the QA department. Your Profile Key Qualifications for the position include: Multiple years of QA experience within the medical device industry, preferably in a smaller-sized company Strong hands-on knowledge of ISO 13485 and ISO 14971 Proven experience leading and supporting audits and inspections Solid understanding of medical device quality systems, risk management, and product development processes Experience working in cross-functional, international environments Fluency in English, both in speaking and in writing We are looking for someone with a can-do attitude, strong organizational skills and a quality-driven mindset. You enjoy taking ownership and accountability to drive continuous improvement of the quality system and work well both independently and in team settings. You can handle multiple tasks and manage priorities in a timely manner and have excellent collaboration and communication skills. You are analytical, detail- and result-oriented and can effectively combine flexibility with a strong decision-making ability. Importantly, you enjoy a dynamic place of work where people matter, and your contributions will make a positive impact. If you are passionate about making a difference in the lives of patients and have the skills and experience to excel in this role, we invite you to apply today! About Inossia AB Inossia aims at improving fracture treatment for osteoporotic patients so that they can live an active life. Inossia is entering a pivotal phase of its growth, with the upcoming launch of its first product and the transition from development to commercial operations. While moving toward market introduction, the company remains committed to ongoing research and development to advance solutions in spine care Inossia has completed a clinical study of 196 patients in 4 countries and 9 clinics Inossia received the Breakthrough Device Designation for Inossia Cement Softener in June 2025 To learn more, please visit www.Inossia.com For more information about the position, please contact: Krishan Johansson Haque, PhD Sr Recruitment Consultant, QRIOS Life Science & Engineering T: +46 (0)72-070 16 53 E: krishan.johansson-haque@qrios.se

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.  WORKING AT GENEZEN Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team. PURPOSE Be an integral part of the quality assurance and quality systems team by providing quality oversight and expertise to operations, manufacturing, and quality control activities. Address terms of product quality and conformance to regulations and Genezen quality policies/procedures. Help in the development of QA people and teams. ESSENTIAL JOB FUNCTIONS / DUTIES * Responsible for Quality Oversight of Manufacturing, Quality Control, and other areas as appropriate, through on the floor presence. Perform assessments during operations activities to ensure all work is performed in compliance with GMP, SOP and regulatory requirements * Provide guidance to production employees with the intent to foster understanding and compliance with SOPs, GMPs and process improvements. * Review cleanroom and supporting area documentation for accuracy and contemporaneous completion in batch records and logbooks * Responsible for ensuring the Genezen documentation is compliant with cGMPs, GDPs, and consistent with other Genezen policies and procedures. * Develop and optimize SOPs and other controlled documents for the Quality Assurance department. * Review and approve SOPs and other controlled documents for the functional areas as the Quality representative. * Review, approve and release critical raw materials for use in production and the quality control laboratories according to established specifications. * Review, assess, and release quality control tests and Certificates of Analysis * Review and approve executed batch records. Provide guidance and support to departments on errors to ensure error reduction. * Assist in the final disposition of master cell banks and viral vector products. * Review and approve qualification/validation protocols and reports and technology transfer reports. * Provides site GMP and GDP training (annually, for new-hires, and as needed). * Initiate and perform Root Cause Analysis for Quality Events such as Deviations and Environmental Excursions. This includes gathering data from various sources across the site (ex. Quality oversight, trend data, and training records), as well as performing interviews of personnel related to the Quality Events. * Working cross-functionally with all departments to ensure Quality Events are thorough and accurate. * Drive Quality Events to closure within on-time closure deadlines. * Review and approve, and implement (as applicable) specifications for labels for media fills, master cell banks and viral vector products, * Review and approve Master Batch Records. * Review and approve Media Fill Protocols and Reports, as well as participate as a Quality observer as needed. * Review and approve Stability Protocols. * Initiate, review, and approve Corrective and Preventative Actions (CAPAs) and monitor CAPA effectiveness with collaboration from Operational areas * Initiate, review, approve and monitor Change Management activities * Work with the other functional areas to give guidance on use of quality systems. * Assist the Lead Auditors to perform site internal audits. * Lead and/or support customer audits and regulatory inspections by participating in either front or back room. * Collaborate cross-functionally (e.g., Operations, Manufacturing, Regulatory, QC, other QA areas) to ensure product is manufactured according to approved procedures and complies with applicable regulations SPECIAL JOB REQUIREMENTS * Adaptability required as work schedule may change based on business needs * Criminal background check and drug screen required * Other duties as assigned KNOWLEDGE, SKILLS & EXPERIENCE EDUCATION / CERTIFICATIONS / LICENSES Essential/Desired Bachelor’s degree in science or related field Essential Experience in industries regulated in-part by, 21 CFR Part 11, 21 CFR 210, 21 CFR 211, 21 CFR 600, 21 CFR 610, Eudralex Volume 4, ICH Quality Guidelines, and Guidance to Industry dockets, as applicable for early phase clinical trials Essential Familiarity of eQMS systems such as Veeva Desired Knowledge of cGxPs, clean room controls, aseptic processing, and EMA and ISO standards for cleanrooms Desired ON-THE-JOB EXPERIENCE   3-5 years of working experience in a Pharmaceutical or Biologics industry in a Quality Assurance role Essential Experience working in with early phase clinical trial production and testing Desired Previous experience with a startup CDMO and/or in the field of Gene Therapy Desired SKILLS / ABILITIES   Manage multiple projects, set priorities, and work in fast-paced environment Essential Communicate confidently and effectively with management, peers and key stakeholders Essential Demonstrate effectiveness in task completion, decision-making, empowerment of others, deviation/nonconformance management, training, and problem solving Essential Work independently and be self-motivated Essential Proven ability to work cross-functionally to achieve business outcomes Essential PHYSICAL DEMANDS While performing the duties of this job, the employee is required to meet the following physical demands: Work Environment * Occasionally exposed to loud noise levels * Regularly sit for long periods of time Movement * Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms * Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl Vision * Frequently utilize close vision and the ability to adjust focus Communication * Frequently required to communicate by talking, hearing, using telephone and e-mail GENEZEN'S CURES VALUE-BASED COMPETENCIES Committed to Science We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare. Urgency in action for the patients We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs. Resilience & Grit in operations We are committed to overcoming challenges, learning from failures, and persistently striving for success.  Execute with Excellence & Integrity We are dedicated to delivering quality results and upholding ethical principals. Solutions driven for our partners We are committed to being a proactive, collaborative, creative and open-minded partner. GENEZEN'S BENEFITS * Paid vacation days, amount based on tenure * Paid sick time * 10 observed holidays + 2 floating holiday + 1 volunteer day * 401(k) plan with company match up to 6% of salary * Share Appreciation Rights * Choice of several healthcare plans * FSA and HSA programs * Dental & vision care * Employer-paid basic term life/personal accident insurance * Voluntary disability, universal life/personal accident insurance * Accidental Death & Dismemberment (AD&D) Insurance ADDITIONAL DETAILS * Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time. * This position requires a criminal background check. * Genezen is an Equal Opportunity Employer. * Genezen participates in EVerify. * Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas. Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.  Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live. Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.