Quality (QA) Lead - CDMO

QA Risk Management Sr Engineer

Unknown Employer

Description QA Risk Management Sr Engineer Summary This is an exciting opportunity to build and lead the quality risk management program at a growing, world-class CDMO specializing in sterile injectable drug products and combination product assembly. As a member of the Technical Systems team within Quality Assurance, you will serve as the site subject matter expert (SME) for quality risk management, partnering across Manufacturing, Engineering, Validation, Quality, and Project Management to embed risk-based thinking into every facet of our operations. If you thrive on creating foundational programs from the ground up and want to make a meaningful impact on patient safety, this role is for you. Reporting to the QA Manager of Technical Systems, the QA Risk Management Sr Engineer is responsible for developing and implementing corporate quality risk management policies, procedures, and tools in compliance with ICH Q9, ISO 14971, ISO 13485, 21 CFR Parts 201, 211, and 820, and applicable EU regulations. This role will establish and maintain the site risk register, provide SME oversight of risk assessments across deviations, change controls, engineering projects, validation activities, medical device and combination product operations, manufacturing processes, and continuous improvement initiatives. The QA Risk Management Sr Engineer will prepare risk management reports and metrics for Quality System Management Review and serve as the QA representative ensuring risk-based decision-making is consistently applied across the organization. Essential Job Functions: Develop, implement, and maintain corporate quality risk management policies, procedures, and work instructions in alignment with ICH Q9(R1), ISO 14971, ISO 13485, 21 CFR Parts 201, 211, and 820, and EU GMP Annex 20 Establish and manage the site-wide Quality Risk Register, ensuring risks are identified, evaluated, controlled, reviewed, and communicated in a timely manner Serve as the QA subject matter expert (SME) for quality risk management, providing oversight and guidance on risk assessments (FMEA, FTA, HACCP, PHA, and other ICH Q9 tools) across all site functions Provide QA risk management oversight for deviations, investigations, CAPAs, and change controls, ensuring risk-based rationale is documented and defensible Support and oversee risk assessments associated with engineering projects, facility and equipment qualification, and validation lifecycle activities Provide QA risk management oversight for medical device and combination product (autoinjector, prefilled syringe, and similar device) assembly operations, ensuring compliance with ISO 13485 and ISO 14971 requirements Author and manage risk management files for combination products and device assembly processes as required by 21 CFR Part 820 and ISO 14971 Prepare and present quality risk management metrics, trending data, and summary reports for Quality System Management Review meetings Partner with cross-functional teams including Manufacturing, Engineering, Technical Services, Supply Chain, Validation, and Project Management to embed risk-based thinking into daily operations and continuous improvement initiatives Facilitate and lead risk assessment workshops, training sessions, and coaching for site personnel on quality risk management principles and tools Support regulatory inspections and client audits as the risk management SME, including preparation of risk-related documentation and responses Monitor and evaluate changes in regulatory guidance, industry standards, and best practices related to quality risk management and recommend updates to site practices accordingly Ensure integration of risk management activities with the site Contamination Control Strategy (CCS) and overall Quality Management System (QMS) Special Job Requirements: Bachelor's degree in Engineering, Life Sciences, Chemistry, or a related scientific discipline; advanced degree preferred Minimum of 7 years of experience in quality assurance, quality risk management, or a related function within a GMP-regulated pharmaceutical, biotechnology, or medical device manufacturing environment Demonstrated experience developing and implementing quality risk management programs, including authoring risk management policies, SOPs, and risk assessment tools Strong working knowledge of ICH Q9(R1), ISO 14971, ISO 13485, 21 CFR Parts 201, 211, and 820, and EU GMP Annex 20 Hands-on experience with formal risk assessment methodologies including FMEA, FTA, HACCP, and Preliminary Hazard Analysis (PHA) Experience in aseptic/sterile injectable drug product manufacturing or parenteral fill-finish operations Excellent written and verbal communication skills with the ability to present risk information clearly to technical and executive audiences Additional Preferences: Experience with combination product (drug-device) risk management and familiarity with autoinjector or prefilled syringe device assembly processes ASQ Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), or equivalent professional certification, ISO 13485 or related certifications Experience establishing a site risk register and integrating risk management outputs into Quality System Management Review Prior experience at a contract development and manufacturing organization (CDMO) Working knowledge of EU GMP Annex 1 (2022) Contamination Control Strategy requirements and integration of risk management into CCS Experience supporting FDA, EMA, and/or client regulatory inspections and audits as a risk management subject matter expert Familiarity with ISPE risk management guidance, PDA Technical Reports, and ASTM E2500 as applied to pharmaceutical and medical device manufacturing Additional info about INCOG BioPharma Services: At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.  All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. By submitting your resume and details, you are declaring that the information is correct and accurate.

Senior QA Manager Validation & Quality

SallyQ AB

Hansa Biopharma develops innovative treatments that give patients with rare and serious immune-mediated conditions a chance to a better life. We are now looking for an experienced Senior QA Manager Validation and Quality, to help shape our quality work at one of the most exciting biotech companies in the Nordics. About the role You will be a key player in a QA team of six dedicated colleagues, all based at our office in Lund. As Senior QA Manager, you will drive and approve validation activities - spanning process, cleaning and analytical method validation - with a clear quality perspective. You will act as subject matter expert supporting cross-functional teams, external partner management and regulatory authority inspections. This is the right role for you if you thrive with both strategic ownership and operational presence - where one day you are reviewing validation documentation and the next you are in dialogue with a CDMO or preparing a team for an authority inspection. Your responsibilities: Provide strategic and operational direction for quality management and validation across development, clinical and commercial manufacturing QA review and approval of validation documentation Supplier quality management: guide and qualify external manufacturing partners (CDMOs/CMOs) throughout the product lifecycle Support authority inspections and internal/external audits of suppliers and vendors Cross-functional collaboration with CMC, Regulatory, Clinical and Supply Chain Drive continuous improvement of the Quality Management System (QMS) and proactively identify areas for development Who are you? We believe you are a seasoned QA professional with broad experience across both drug substance (DS) and drug product (DP) manufacturing. You are thorough and results-oriented, but also a natural collaborator who knows when to take the lead and when to seek input from others. We are looking for someone with: Advanced degree (Ph.D. or M.Sc.) in Chemical Engineering, Chemistry, Pharmaceutical Sciences or a related discipline 10+ years of biopharmaceutical industry experience with a focus on QA, process development and validation Proven track record of leading validation activities for DS and DP through clinical and commercial stages Strong knowledge of aseptic manufacturing and biotechnology processes Deep understanding of regulatory requirements (FDA, EMA, ICH) related to manufacturing and validation Experience managing external partners and CDMOs/CMOs Experience of authority inspections (FDA, EMA) as presenter and/or coordinator Strong communication skills and the ability to influence across functions and organisational levels What we offer At Hansa, you will not just have a job - you will have a role where your work directly contributes to changing lives for patients with acute and complex immune disorders. A close-knit, welcoming culture in a mid-sized company where you can see how your contribution makes a difference The opportunity to help build a fully integrated biopharmaceutical company with global reach Talented, driven colleagues with an open and entrepreneurial mindset A strong pipeline built on Hansa’s proprietary IgG-cleaving enzyme technology platform Office in Lund, at the heart of a vibrant Life Science ecosystem Our values At Hansa, we are guided by our core values: Accountability, Courage, Integrity and Pioneering. We believe in the power of diversity and are committed to building an inclusive workplace where every perspective is valued. Appealing? Send in an application as soon as possible. In this recruitment, Hansa Biopharma is collaborating with SallyQ. For questions, please contact Ellinor Crafoord, Senior Recruitment Consultant, +46793554257 or ellinor.crafoord@sallyq.se.

QA Associate, Weekend Day or Night Shift

Unknown Employer

Description Working closely with the Quality Manager, the QA Associate will be instrumental in ensuring site compliance with Regulations, ISO Standards, organizations SOPs as well as support in championing and developing organization’s Quality Mindset, as well as a culture of efficiency, attention to detail, and on time delivery.  The QA Associate will need to provide support with identifying operational and quality gaps. The Quality Assurance Associate will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and partners.  The QA Associate will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences.  The QA Associate will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills.  The QA Associate will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority. This role supports Weekend operations (Friday–Sunday). Two shifts are available: Days (7:00 AM–7:30 PM) and Nights (7:00 PM–7:30 AM). Candidates must demonstrate availability and flexibility for occasional support outside of their standard shift hours. Essential Job Functions: ·       Maintain a Quality Assurance presence and provide process confirmation on the manufacturing floor. ·       Review and approve documentation for Quality approval, including but not limited to on-floor batch record review, logbooks, work orders, procedures, etc. ·       Collaborate with Manufacturing/Operations team and lead or provide support with investigations to resolve equipment and process related deviations. ·       Support other QA personnel with batch record reviews, material release, etc. ·       Prioritize and coordinate his/her time in balancing production timelines with product quality assurances. ·       Exercise rapid decision-making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions or escalate the issue to Manager for resolution. ·       Provide support as needed in a cross-functional capacity on deviation investigative processes using root cause analysis tools, report writing, and mitigation development using risk analysis tools. ·       Exemplify and take proactive approaches in terms of safety expectations, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals. ·       Utilize various paper and automated systems (Veeva, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity for site policies, procedures, and batch records. ·       Use technical skills and applied statistics to analyze and track deviations and to identify sources of variability and error site processes. ·       Ability to manage multiple projects in a fast-paced environment. Special Job Requirements: ·       Bachelor’s Degree required or equivalent; degree preferred to be in Science (Chemistry, Biology, Biochemistry, Microbiology etc.) ·       Minimum of 2 years with experience working as Quality in a GMP Manufacturing environment, and/or as an Operator within a Pharmaceutical Manufacturing environment. ·       Moderate knowledge of regulations and quality systems such as deviations,  Non-Conformance, CAPA, etc.. ·       Understanding of Good Documentation Practices (GDPs) and its criticality. ·       Excellent written and verbal communication skills. ·       General computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.). Additional Preferences: ·       Hands-on experience with aseptic manufacturing, inspecting finished products, and Acceptable Quality Limits (AQLs). ·       Experience with Continuous improvement, Six Sigma, and/or Lean principles. Additional info about INCOG BioPharma Services: At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.  All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1. By submitting your resume and details, you are declaring that the information is correct and accurate.