Quality Manager jobs at Grifols - 733 jobs

A global biotechnology company is seeking a Director of R&D Quality Governance & Risk Management to lead and enhance the governance framework supporting risk-based decisions. This strategic role requires 10+ years of R&D QA experience, strong leadership presence, and operational agility. Candidates should possess exceptional collaboration skills and mentorship capabilities. The role offers flexibility in a hybrid work environment with competitive compensation and comprehensive benefits. #J-18808-Ljbffr

Breaking Data is a boutique healthcare marketing agency serving leading pharmaceutical, biotech, and medical device companies. We specialize in scientific storytelling, creative strategy, and high-impact communications that bring complex brand narratives to life across print, digital, and training platforms. Founded by marketers, for marketers, we pride ourselves on delivering thoughtful, intuitive, and beautifully executed work. Our team is full of “A-teamers”: curious, collaborative, detail-driven people who care deeply about the craft and the quality of what we create. We believe co-location fuels creativity, alignment, and culture. While we offer flexibility, this role is intended for someone who can work 3 days onsite in our Cherry Hill, NJ office and 2 days remote. Senior Editorial and Quality Lead (Healthcare Agency)| Boutique Life Sciences Agency Location: US-Cherry Hill, NJ Employment Type: Full-time Benefits: Health Insurance Compensation, 401K program, Paid time off, and company holidays Opportunity Overview Breaking Data seeks a meticulous Senior Editorial and Quality Lead to serve as the central hub for editorial excellence across pharmaceutical and healthcare deliverables. This hands-on role owns quality control from post-writing drafts through design, reviews, and client approvals-focusing on grammar, style mastery, layout accuracy, and workflow efficiency. Ideal for an experienced editor passionate about the craft of editing. About the Role The Senior Editorial and Quality Lead will own editorial quality control as the central hub across all deliverables-from post-medical writing drafts through design layouts, internal strategy reviews, and client approvals. This hands-on role encompasses proofreading, light editing, layout verification, and workflow coordination for slides, print materials, digital assets, training modules, and long-form content, serving pharmaceutical and healthcare clients. Work closely with medical writers, designers, strategists, and account teams to ensure grammar, style, accuracy, and layout integrity meet the highest agency and client standards. Key Responsibilities Editorial Quality Control Proofread and edit copy developed by medical writers for grammar, clarity, consistency, spelling, accuracy, AMA Manual of Style, and client-specific guidelines. Verify references, superscripts, citations, medical terminology, numeric values, units, symbols, and data formatting. Perform light editing or rewrites to address minor issues and maintain project efficiency. Brand & Compliance Consistency Ensure content aligns with each client's editorial style, tone, branding expectations, and regulatory requirements (including PI/ISI placement when applicable). Confirm correct application of references, anchors, superscripts, and citation formatting. Design & Layout Review Review designed documents and slides (PowerPoint, InDesign, PDFs) to confirm clean, consistent formatting and layout. Verify alignment between copy and design elements (tables, charts, visuals, callouts); identify inconsistencies in spacing, bullets, alignment, superscripts, or content order that could alter meaning. Process & Workflow Execution Manage editorial checkpoints and coordinate handoffs across medical writers, designers, internal strategy reviewers, and clients on multiple concurrent projects. Implement QC edits directly; track and ensure all internal, client, and MLR feedback is accurately incorporated with proper version control and file naming. Serve as the final quality assurance step before client delivery. Requirements Minimum 4-5 years of editorial or proofreading experience in a healthcare, pharmaceutical, or medical communications agency setting. Strong knowledge of the AMA Manual of Style and the ability to apply client-specific style guides and branding requirements. Experience reviewing healthcare or scientific content with a high level of accuracy for terminology, data, units, and references. Demonstrated ability to manage multiple projects and deadlines in a fast-paced, detail-oriented environment. Proficiency in Microsoft Office, Adobe Acrobat Pro, and cloud-based document systems (eg, SharePoint/OneDrive). Exceptional attention to detail and a commitment to editorial precision and quality control. Strong communication and collaboration skills for working with medical writers, designers, strategists, and account teams. Education Bachelor's degree in English, Communications, Journalism, or a related field; a life sciences background is a plus but not required for this role. Work environment Our Cherry Hill, NJ office offers a flexible and collaborative environment. We align projects with each team member's core skills, striking a balance between fun and efficiency to achieve our goals and those of our clients. This is a hybrid position, with 3 days onsite and 2 days remote. Application Process To apply, please submit your resume (and, if available, editing samples) directly through this LinkedIn job posting. Candidates selected for the next steps will be asked to complete a brief editing exercise.

The Project Quality Engineer is responsible for ensuring the effective establishment and maintenance of the Delcath Quality System and ensuring that the facility is fully compliant to all applicable FDA, ISO regulations and the Medical Device Directives/Regulations. The Project Quality Engineer is responsible for providing quality project management and support for the company by working with the Senior Quality Assurance Manager to assure proper GMP compliance within Delcath Systems. PRIMARY DUTIES AND RESPONSIBILITIES: Project Management - lead continuous improvements projects. Participate on new product design teams as the design quality assurance engineer. Support design verification, process validation, software validation and test method validation. Generate procedures, specifications, and labeling as required. Support the Corrective Action and Preventive Action Program. Support the Internal Audit Program through the performance of audits as required. Support the Supplier Quality Program and perform on-site quality audits, as required. Support external regulatory audits. Understand and communicate component and finished product specification requirements. Support the Management Review process to monitor and evaluate Quality System effectiveness. Maintain effectiveness of the Quality Management System through the resolution of quality concerns and related issues as required. A minimum of Bachelor's degree in engineering or physical sciences is preferred. A minimum of five or more years of experience in quality assurance, quality engineering, project management or related functions in an FDA regulated industry or ISO certified organization is required. Must be team oriented, with the ability work well with diverse cross-functional teams. Must possess strong analytical and process skills, and be computer proficient in EXCEL, Word, etc.

A leading global biotechnology firm in Boston seeks a Principal Engineer to lead the automation of pre-clinical data pipelines and regulatory reporting solutions. This role focuses on driving modernization and standardization initiatives, leveraging AI technologies, and enhancing data consumption practices. Candidates should possess strong programming skills and a degree in a relevant field, with a minimum of five years in technical leadership within the biotechnology industry. The position offers a hybrid work model and a comprehensive benefits package. #J-18808-Ljbffr

Core Hours: Monday - Friday, 8:00 am - 5:00 pm Purpose and Scope Provide direct supervision of a team of analysts responsible for the testing and release of Tolmar products in support of manufacturing timelines. Essential Duties & Responsibilities Prioritize workload to meet timelines while ensuring on-time delivery of all projects, testing and action items. Take ownership of tasks and results from initiation to completion to meet commitments and proactively address outcomes. Escalate and communicate items which arise per the timelines specified in the department escalation strategy. Execute all business and department goals and initiatives on time. Ensure adherence for compliance with all processes and procedures including training completions, QE and CAPA due dates, notebook and logbook audits, archiving, schedules, internal assessments. Issue all Certificates of Analysis within 2 business days of last test completion. Generate, monitor and report weekly team and analyst KPIs. Supervise the testing and release of Tolmar products, cleaning samples, EM, Bioburden, Endotoxin, raw materials, and stability samples. Strive to balance workload across all sites and teams to ensure adequate resource allocation. Partner with the scheduler to schedule all testing and reviews, review the weekly schedule and ensure company and department targets are met in the shortest possible cycle time. Provide assistance, training and leadership for direct reports through utilization of the OTD resources. Create, revise and monitor training progress utilizing training matrices for immediate functional areas, and collaborate with team on remediation of training gaps for site training matrix. Set and communicate clear expectations for analysts including providing regular feedback and coaching, monitoring progress and fostering employee development to align individual and team performance with organization goals. Create and revise developmental plans to help employees grow their skills and advance their careers. Monitor and discuss progress of employee's performance, growth and development in one on ones utilizing the career ladder and KPIs. Establish sample priorities for QC scheduler, submit schedule tickets as needed and ensure adherence to ship dates. Partner with the investigations team and the scheduler to ensure all actions for QEs are completed in 24 hours, second analyst testing is completed in less than 5 business days and QEs are closed on time (less than 45 business days). Support and execute all potential 3-day field alert investigations and actions expeditiously. Submit document change requests for all document updates and minimize document revisions for routine updates where possible. Ensure all samples logged into the LIMS system are submitted correctly. Identify, and complete cost savings initiatives and facilitate continuous improvement. Participate in leadership development activities and take an active role during department and company activities. Aid in setting procedure and ensure that all operations and functions (including the laboratory) are in full FDA, cGMP compliance and staff is properly trained. Utilize senior analysts to assist in training, document updates, laboratory investigations, projects, or advanced technical issues. Conduct and coordinate laboratory investigations, and all associated actions. Review and approve technical reports, test methods, specifications and procedural documents and ensure overall validity of the analytical results and review stability reports. Participate in project teams, company and department meetings, third party audits, and regulatory audits. Monitor departmental spending to stay within the established budget. Demonstrate leadership aptitude in technical functions and people management. Ability to perform designated duties under minimal supervision and support departmental management in all aspects of organizational functions. Accountable for maintaining an atmosphere of teamwork, cordiality and respect towards co-workers. Accountable for meeting departmental and compliance timelines. Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to, container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures. Participate in the interview and selection process for candidates, as required. Perform other duties as required by business demands. Knowledge, Skills & Abilities Possesses a strong sense of purpose and drive to meet deadlines without sacrificing quality. Balances the need for speed with a commitment to accuracy and quality, completing tasks thoughtfully and effectively Expert knowledge in analytical testing of drug substances and formulations for Chemistry or Microbiology. Ability to perform designated duties under minimal supervision and support departmental management in all aspects of organizational functions. Proficient with computer systems for sample tracking, laboratory equipment, raw data handling and storage. Knowledge in analytical method validation and instrument qualification. Thorough knowledge of government regulations of drugs and medical devices as they apply to laboratory work. Technical leadership when working on complex problems within a technical scope in which analysis of situations or data requires an in-depth evaluation of various factors. Exceptional interpersonal and organizational skills that lead directly to the advancement of others and of the QC department. Ability to supervise a team of analytical professionals that is fully compliant with current Good Manufacturing Practices. Knowledge of analytical troubleshooting and product investigation. Effective oral and written communication. Proficient in the use of analytical laboratory instruments such as HPLC, FTIR, GPC, GC, and UV-Vis spectrophotometers, CCIT, Endotoxin, MODA,. Ability to prepare, review, conduct and assess analytical method validations, feasibility and suitable for use. Ability to coordinate activities to assure customers' needs are met in terms of sample analysis cycle time. Core Values The Quality Control Supervisor is expected to operate within the framework of Tolmar's Core Values: Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together. Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes. Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace. Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality. Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future. Education & Experience Bachelor's degree in science, preferably in Chemistry or Biochemistry, or Microbiology. Six or more years' experience in an analytical laboratory environment with at least five years in a pharmaceutical GMP setting. Supervisory or team lead experience is preferred. Working Conditions Laboratory setting. Will be exposed to solvents, bio-hazardous materials, hazardous waste, and pharmaceuticals. Must be adaptable to shifting priorities and operate with a sense of urgency while maintaining high quality to meet important timelines in a high throughput lab. Business demands present a need to work extended hours. On call weekend support will be required with a minimum of 8 on call weekends each year. Compensation and Benefits Annual pay range $100,000 - $105,000 depending on experience Bonus Eligible Benefits information: careers/employee-benefits Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience. Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

Core Hours: Monday - Friday, 8:00 am - 5:00 pm Purpose and Scope The Senior Automation and AI CSV Engineer will lead the design, implementation, and validation of automated systems and AI-driven solutions within a sterile injectable pharmaceutical manufacturing environment. This role ensures compliance with regulatory requirements (FDA, EMA, ICH) and company standards for computerized systems, automation platforms, and AI-enabled technologies used in production, quality control, and data analytics. Essential Duties & Responsibilities Automation & AI Validation: Develop and execute validation strategies for automated systems, robotics, and AI-based tools in compliance with GAMP 5, 21 CFR Part 11, FDA's CSA for Production and Quality System Software, Annex 11, Annex 22, and PIC/S. Perform risk assessments and ensure data integrity for AI-driven decision-making systems. Author and review validation documentation (URS, FS, DS, IQ/OQ/PQ protocols, reports). System Lifecycle Management: Oversee system implementation, upgrades, and change control for automation and AI platforms. Collaborate with IT, Engineering, and Quality teams to maintain validated state of systems. Regulatory Compliance: Ensure adherence to cGMP, FDA, EMA, and global regulatory guidelines for sterile injectable manufacturing. Support audits and inspections by providing validation evidence and technical expertise. Innovation & Continuous Improvement: Identify opportunities to integrate AI and advanced analytics for process optimization and predictive maintenance. Drive digital transformation initiatives. Quality Oversight & Approval: Provide independent quality oversight for automation and AI validation activities. Review and approve validation protocols, reports, and change control documentation to ensure compliance and data integrity. Act as a quality representative during system implementation and qualification phases. Adhere to company and departmental timelines with high accuracy and quality. Maintain an atmosphere of teamwork, cordiality, and respect towards co-workers. Performs other duties as assigned. Core Values This position is expected to operate within the framework of Tolmar's Core Values: Center on People:We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together. Are Proactive & Agile:We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes. Act Ethically:We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace. Constantly Improve:We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality. Are Accountable:We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future. Knowledge, Skills & Abilities Excellent organizational and project management skills. Excellent oral and written communication skills. Ability to work independently with minimal supervision and as part of a cross-functional team. Advanced knowledge of Automation and CSV/CSA principles, industry guidance, regulatory requirements, cGMP practices, and ICH guidelines. Strong project management and cross-functional leadership skills. Ability to author strong technical reports free of errors. Advanced knowledge with Microsoft Office Suite, and various GMPS systems such as Veeva eQMS, Maximo CMMS, BMS, LIMS, CDS, and ERPs. Familiarity with SCADA, PLC, MES, and AI platforms from simple context analysis tools to large language modeling, prompt engineering and the role of human interaction for process engineering and establishment of trustworthy data. Advanced troubleshooting and problem-solving skills. Ability to manage multiple projects concurrently and under tight time constraints. Education & Experience Bachelor's degree in Engineering, Computer Science, Pharmaceutical Sciences, or related field required Master's degree in Engineering, Computer Science, Pharmaceutical Sciences, or related field preferred Minimum of 8 years' experience in pharmaceutical automation and computerized system validation. Strong knowledge of sterile injectable manufacturing processes and aseptic techniques. Hands-on experience with AI/ML applications in manufacturing or quality systems preferred. Expertise in GAMP 5, 21 CFR Part 11, Annex 11 and knowledge of Annex 22 compliance. Proficiency in risk-based validation and data integrity principles. Working Conditions Working conditions include general office environment. Business demands may require working extended hours. Compensation and Benefits Annual pay range $125,000 - $135,000 depending on experience Bonus Eligible Benefits information: careers/employee-benefits Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience. Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

Crane Aerospace and Electronics has an exciting opportunity for a Quality Manager at our West Caldwell, NJ location. About Crane: Crane Aerospace & Electronics supplies critical systems and components to the aerospace and defense markets. You'll find Crane Aerospace & Electronics in some of the toughest environments: from engines to landing gear; from satellites to medical implants and from missiles to unmanned aerial systems (UAS). Every time you use phone navigation, make a bank transaction or have food delivered to your home, Crane Aerospace & Electronics Microwave product is hard at work. Located in the tight-knit, family-first West Caldwell, NJ., community, our West Caldwell facility supplies industry-leading microwave components and systems for use in space, defense and commercial applications, including GPS III satellites. With more than 60 years of expertise, our Microwave group has proven capabilities in major military, communications, electronic warfare, radar and satellite systems. Start the next chapter of your career with Crane Aerospace & Electronics! Job Summary: The Quality Manger is responsible for establishing, implementing and directing quality assurance efforts to ensure components and other materials in finished goods and products conform to quality standards based on the requirements and expectations of the organization and customer. Essential Functions: • Management, training and mentoring of all Quality Department employees at site level • Lead problem solving Kaizen events • Manage budget, costs and expenditures within the Quality function and applicable functional support requirement. • Responsible for investigation of and formal response to all customer complaints(SCARS) • Responsible for failure analysis & corrective action reporting system(FRACAS) • Participate in internal and external quality audits • Any other task assigned by your supervisor or management Minimum Qualifications: • Experience: 5+ years Quality assurance experience in the defense, space electronics or high end aerospace industry in either a management role or senior quality engineering position; Experience with Lean and Six Sigma methodologies • Knowledge: Expert knowledge of Quality Management Systems as well as Process Improvement and Control Techniques; Demonstrated knowledge of manufacturing best practices, process control (SPC, Six Sigma), logistics processes (inventory management), engineering management (project management) and safety management • Skills/Abililties: Demonstrated strong analytical and problem solving skills; Effective written and verbal communication skills and interpersonal skills; Ability to manage through influence; Abilty to demonstrate a strong sense of urgency • Education/Certification: B.S. degree in electrical or mechanical engineering, or related field Preferred Qualifications: • Certified ISO/AS lead assessor credentials Working Conditions: • Standard office environment • Work requires substantial visual concentration on detail • Working conditions are normal for a manufacturing environment • Manufacturing operations may require the use of safety equipment to include but not limited to: eye safety glasses, gowning, masks, hearing protectors, heel/wrist straps and any other required PPE • May be exposed to unusual environmental conditions such as loud noises, cold temperatures, confined spaces, dust or fumes • Travel up to 10% may be required Standing: 30% *percentage is approximate and may vary depending on work task Sitting: 70% *percentage is approximate and may vary depending on work task Lifting (in pounds): up to 25 pounds Pushing (in pounds): up to 25 pounds Mental/Visual: use of computer, calculator, filing cabinets Workspace: cubicle/desk Crane Co. reserves the right to change or assign other duties to this position. The statements contained herein reflect general details as necessary to describe the principal functions of this job, the level of knowledge and skill typically required and the scope of accountability and responsibility. These descriptions should not be considered to be all-inclusive listings of work requirements. Crane Co. is an Equal Opportunity Employer and does not discriminate on the basis of race, color, creed, religion, sex, national origin, marital status, age, sexual orientation, gender identity characteristics or expression, physical or mental disability, pregnancy, medical condition, genetic information, or U.S. military or veteran status or any other characteristic protected under federal, state, or applicable local law, in recruiting, hiring, training and promoting Salary range: $132,020.70 - $162,894.20. Several factors contribute to actual salary, including experience in a similar role or performing comparable job responsibilities, skills, training, and other qualifications. Some roles may be eligible for participation in performance-based bonus programs. This description has been designed to indicate the general nature and level of work being performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Crane Company. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, gender, sexual orientation, general identity, national origin, disability or veteran status.

Responsibilities The ASC Clinical-Quality Manager provides leadership in daily clinical operations of the ASC in accordance with State rules and regulations, and AAAHC standards for ambulatory surgical facilities. Develops and enforces compliance with ASC policies and procedures. This position works closely with the providers, ASC Director, Clinical Manager, Business Office Manager, ASC Educators, Staff, and Medical Staff Leadership. This position is responsible for identifying, implementing, monitoring and reporting on Quality Improvement activities within the ASC. Provides leadership and oversight for the materials management operations of the ASC Job Title: ASC CLINICAL-QUALITY MANAGER Location: Pearland Administrative Office Department: ASC Administration Job Type: Full Time Salary Range: $101,147 - $124,947 (Pay is based on several factors including but not limited to education, work experience, certifications, etc.) Qualifications Education Required: MSN 2 years or BSN with 5 years of experience Preferred: MSN preferred Experience Required: 3 years clinical in ASC, OR or critical care, 2 years in management, education, infection control or research. Preferred: Adult educator experience, Quality and/or, outcomes monitoring experience. Infection control or compliance experience. License(s) Required: Texas RN Preferred: Specialty Certification as AORN, CQHP or ICP. Special Skills Required: Knowledge of compliance regulations and nursing standards for surgery. Excellent Microsoft Office (Word, Excel, Power Point skills,) adult education skills, quality/research skills. Preferred: Computer-based education skills, database development and management skills. Other Required: Previous AAAHC preparation experience Preferred: N/A Working Environment: Other- Ambulatory Surgery Center About Us Start your career journey and become a part of a community of renowned Healthcare professionals. Kelsey-Seybold Clinic is Houston's fastest growing, multispecialty organization with more than 40 premier locations and over 65 specialties. Our clinics are comprised of more than 600 physicians and as we continue to grow, our focus is providing quality patient care by adding to our team of clinical and non-clinical professionals that work together in a convenient, coordinated, and collaborative manner. Enjoy the rewards of a successful career while maintaining a work/life balance by joining our team today and changing the way health cares. Why Kelsey-Seybold Clinic? Medical, Vision, and Dental Tuition Reimbursement Company Matching 401K Employee Reward and Recognition Program Paid time off for vacation, sick, and holidays Employee Assistance Program Continuing Medical Education allowance

About QTS QTS offers critical end-of-line services for medical device OEMs including finished device assembly, packaging and sterilization management. QTS is part of the Cretex Medical family of companies. Learn more at ******************** and ********************** Responsibilities Quality Manager Ideal Candidate Profile QTS is currently seeking an experienced, energetic, responsive, and well-organized full time Quality Manager. This position will be responsible for building, managing, and leading the quality department staff, working in partnership with sales, engineering, procurement, and operations, to ensure the highest possible quality products to the QTS Quality Management System. This role will support our customer facing function to ensure customer requirements are met, drive quality customer communications, and support the quality and delivery of the products. This position will ensure the products and processes meet the quality management system requirements and methods in alignment with the FDA QSR and ISO requirements and utilize metrics to continually improve quality processes and efficiency. This would be an on-site position. *This position is not currently offering relocation assistance. Quality Manager Job Summary Establish and lead a high-performing team of Quality Engineers, Quality Technicians, and Customer Facing Quality, providing mentorship and coaching to staff as needed. Manage customer quality communication and relationships. Assist in the resolution, documentation, customer responses for complaints. Execute quality policies, quality objectives, and quality plans that support the corporate strategic business goals and conform to customer, internal, ISO 9001:2015 and EN ISO 13485:2016, regulatory and legal requirements. Ensure effective coordination of investigations, root cause analysis, risk assessments, field actions and implementation of change control and corrective and preventive actions to the adhered timelines. Professional and timely cross functional communication with other departments and customers. Monitor and assess the QMS processes for compliance, effectiveness, and opportunities for improvement, ensuring product meets requirements and continued certification to applicable standards. Maintain Quality System Dashboards, Scorecards / Key Performance Indicators for the quality of products. Review and monitor trends, communicating issues to department management. Contribute to and assist in providing quality system training as appropriate. Assures in process inspection, batch record review, sterile and product release complies with the quality system. Support the Management Review process. Drive process implementation including quality control plans, validation, qualifications (IQ, OQ, PQ) and root cause - corrective action. Support a culture of Operational Excellence, inclusive of lean and six sigma principles. Act as the Deputy Management Representative should need arise. Act as a representative for customer audits, and support external audits by regulatory authorities and registration agencies. Qualifications Quality Manager Skills and Experience Bachelor's degree in Engineering, Sciences, Quality, or relevant experience. 8 years of experience in Quality or Engineering in a manufacturing setting in a regulated field. 5 years of leadership experience. Clear and effective verbal and written communication skills. Strong attention to detail and organizational skills. In depth knowledge of 13485, 14971, FDA Quality System Regulation, 21CFR Part 820, Good Manufacturing Practices, or other relevant regulated requirements. Experience with Corrective and Preventative Actions, including the ability to lead cross functional teams to solve problems and complete root cause analysis. Working knowledge of quality tools, variable and attribute sampling plans, root cause analysis, DOE, Statistics, Lean Manufacturing, and Six Sigma - an asset. Demonstrated leadership skills with the ability to build, mentor and maintain an efficient, effective organization with a team focused on continual improvement and holds team members accountable. Experience with finished device manufacturing. Ability to prioritize, plan, and evaluate deliverables to established strategic goals and timeline. Ability to consistently achieve short and long-term business results. Ability to work in a fast-paced team environment. Desirable Criteria & Qualifications Continuing education, including participation in local chapters, associations, and/or organizations. What Is It Like to Work for QTS? At QTS, we are passionate about quality as the services we provide have a direct impact on the quality of life for others and we pride ourselves on our culture and work environment. Here are some of things that employees have said about working at QTS: “I would describe my coworkers as kind and friendly.” “… I interned at QTS, then I went back to school… I was brought on as a shared service engineer, then I moved into a role with more customer interaction associated with it. All in all, a good fun ride so far and I can't wait to keep it going!” “Three words that I would use to describe QTS's culture are: Respectful, Fast-paced, and Fun!” We encourage you to explore the many opportunities that Quality Tech Services could offer you as an employee and as a valued team member. Pay Range USD $97,900.00 - USD $146,900.00 /Yr. Pay Range Details This pay range reflects the base hourly rate or annual salary for positions within this job grade, based on our market-based pay structures. Actual compensation will depend on factors such as skills, relevant experience, education, internal equity, business needs, and local market conditions. While the full hiring range is shared for transparency, offers are rarely made at the minimum or maximum of the range. Company Benefits All Employees: Our 401k retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program (based on years of service), Cretex University, 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost, wellness program with incentives, an employee death benefit, and employee sick and safe leave are available to all Cretex employees. 20+hours: Cretex's medical benefit package includes: comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider); vision insurance; a pre-tax health savings account, healthcare and dependent care pre-tax reimbursement accounts; paid holidays, paid time off; and our discretionary profit sharing program are available to employees working 20+ hours/week. 30+ hours: Parental Leave, accident and critical illness benefits, optional employee, spouse, and child life; short and long term disability; company provided life insurance; and tuition assistance programs are available to employees working 30+ hours per week. (Some benefits are subject to eligibility criteria.) Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law. Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit *********************

About QTS QTS offers critical end-of-line services for medical device OEMs including finished device assembly, packaging and sterilization management. QTS is part of the Cretex Medical family of companies. Learn more at ******************** and ********************** Responsibilities Quality Manager Ideal Candidate Profile QTS is currently seeking an experienced, energetic, responsive, and well-organized full time Quality Manager. This position will be responsible for building, managing, and leading the quality department staff, working in partnership with sales, engineering, procurement, and operations, to ensure the highest possible quality products to the QTS Quality Management System. This role will support our customer facing function to ensure customer requirements are met, drive quality customer communications, and support the quality and delivery of the products. This position will ensure the products and processes meet the quality management system requirements and methods in alignment with the FDA QSR and ISO requirements and utilize metrics to continually improve quality processes and efficiency. This would be an on-site position. * This position is not currently offering relocation assistance. Quality Manager Job Summary * Establish and lead a high-performing team of Quality Engineers, Quality Technicians, and Customer Facing Quality, providing mentorship and coaching to staff as needed. * Manage customer quality communication and relationships. Assist in the resolution, documentation, customer responses for complaints. * Execute quality policies, quality objectives, and quality plans that support the corporate strategic business goals and conform to customer, internal, ISO 9001:2015 and EN ISO 13485:2016, regulatory and legal requirements. * Ensure effective coordination of investigations, root cause analysis, risk assessments, field actions and implementation of change control and corrective and preventive actions to the adhered timelines. * Professional and timely cross functional communication with other departments and customers. * Monitor and assess the QMS processes for compliance, effectiveness, and opportunities for improvement, ensuring product meets requirements and continued certification to applicable standards. * Maintain Quality System Dashboards, Scorecards / Key Performance Indicators for the quality of products. Review and monitor trends, communicating issues to department management. Contribute to and assist in providing quality system training as appropriate. * Assures in process inspection, batch record review, sterile and product release complies with the quality system. * Support the Management Review process. Drive process implementation including quality control plans, validation, qualifications (IQ, OQ, PQ) and root cause - corrective action. * Support a culture of Operational Excellence, inclusive of lean and six sigma principles. * Act as the Deputy Management Representative should need arise. * Act as a representative for customer audits, and support external audits by regulatory authorities and registration agencies. Qualifications Quality Manager Skills and Experience * Bachelor's degree in Engineering, Sciences, Quality, or relevant experience. * 8 years of experience in Quality or Engineering in a manufacturing setting in a regulated field. * 5 years of leadership experience. * Clear and effective verbal and written communication skills. * Strong attention to detail and organizational skills. * In depth knowledge of 13485, 14971, FDA Quality System Regulation, 21CFR Part 820, Good Manufacturing Practices, or other relevant regulated requirements. * Experience with Corrective and Preventative Actions, including the ability to lead cross functional teams to solve problems and complete root cause analysis. * Working knowledge of quality tools, variable and attribute sampling plans, root cause analysis, DOE, Statistics, Lean Manufacturing, and Six Sigma - an asset. * Demonstrated leadership skills with the ability to build, mentor and maintain an efficient, effective organization with a team focused on continual improvement and holds team members accountable. * Experience with finished device manufacturing. * Ability to prioritize, plan, and evaluate deliverables to established strategic goals and timeline. * Ability to consistently achieve short and long-term business results. * Ability to work in a fast-paced team environment. Desirable Criteria & Qualifications * Continuing education, including participation in local chapters, associations, and/or organizations. What Is It Like to Work for QTS? At QTS, we are passionate about quality as the services we provide have a direct impact on the quality of life for others and we pride ourselves on our culture and work environment. Here are some of things that employees have said about working at QTS: * "I would describe my coworkers as kind and friendly." * "… I interned at QTS, then I went back to school… I was brought on as a shared service engineer, then I moved into a role with more customer interaction associated with it. All in all, a good fun ride so far and I can't wait to keep it going!" * "Three words that I would use to describe QTS's culture are: Respectful, Fast-paced, and Fun!" We encourage you to explore the many opportunities that Quality Tech Services could offer you as an employee and as a valued team member. Pay Range USD $97,900.00 - USD $146,900.00 /Yr. Pay Range Details This pay range reflects the base hourly rate or annual salary for positions within this job grade, based on our market-based pay structures. Actual compensation will depend on factors such as skills, relevant experience, education, internal equity, business needs, and local market conditions. While the full hiring range is shared for transparency, offers are rarely made at the minimum or maximum of the range. Company Benefits All Employees: Our 401k retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program (based on years of service), Cretex University, 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost, wellness program with incentives, an employee death benefit, and employee sick and safe leave are available to all Cretex employees. 20+hours: Cretex's medical benefit package includes: comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider); vision insurance; a pre-tax health savings account, healthcare and dependent care pre-tax reimbursement accounts; paid holidays, paid time off; and our discretionary profit sharing program are available to employees working 20+ hours/week. 30+ hours: Parental Leave, accident and critical illness benefits, optional employee, spouse, and child life; short and long term disability; company provided life insurance; and tuition assistance programs are available to employees working 30+ hours per week. (Some benefits are subject to eligibility criteria.) Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law. Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit *********************

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice (https://urldefense. proofpoint. com/v2/url?u=https-3A__www. takedajobs. com_privacynotice&d=DwMFAg&c=eIGjsITfXP_y-DLLX0uEHXJvU8nOHrUK8IrwNKOtkVU&r=R7Z8seTzCwqpIAi7APe73INoZm9-sx CdHQKjwfWPCQs&m=dHDH9k7lo2jkh-wOGxeg4p4mAfV8Vr_FCuR60MDlbTo&s=Tj67ufwJLuB1vZlHjecELumJYbWpaHHiC9kI2nnRDKU&e=) and Terms of Use (https://urldefense. proofpoint. com/v2/url?u=https-3A__www. takeda. com_terms-2Dof-2Duse_&d=DwMFAg&c=eIGjsITfXP_y-DLLX0uEHXJvU8nOHrUK8IrwNKOtkVU&r=R7Z8seTzCwqpIAi7APe73INoZm9-sx CdHQKjwfWPCQs&m=dHDH9k7lo2jkh-wOGxeg4p4mAfV8Vr_FCuR60MDlbTo&s=_CIJE9CeroUy1ZLHeCKCoxM1jCAPZSz9Vq5yEGoRCGg&e=) . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. OBJECTIVES/PURPOSE Monitors all systems and activities to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Shire Quality System, and other applicable regulations for a plasma center. Authorized and responsible to cease operations within the center or stop source plasma shipment(s) if product or donor safety is or may be compromised. All below listed responsibilities must be completed in compliance with federal, state, local and company-specific regulations related to quality of product, employee and donor safety, and to the proper performance of day-to-day activities. Employees must also maintain complete and accurate records, in accordance with cGMP. ACCOUNTABILITIES Regulatory Compliance: (15%) Stays current with federal, state, local and company-specific rules, regulations, and practices. Ensures center compliance with all federal, state, local and company-specific regulations related to quality of product, employee and donor safety. Ensures that SOP's are current and that staff perform routine tasks according to SOP through direct observation. Plasma Collection Center Quality Assurance Oversight: (80%) Reviews operational records to ensure they are complete, accurate and compliant with cGMP requirements. Tracks deviations and trending in operating procedures and policies through established mechanisms. Reports errors, deficiencies, discrepancies and observations to center management and the Regional Quality Manager. May stop operations or shipments when donor or product safety is or may be compromised. Identifies potential SOP revisions as needed to support continuous improvement. Works in collaboration with center manager and management team to prepare for and host (if needed) internal auditors and external inspectors. Assists center management teams to ensure timely closure of audit observations. Tracks responses to and evaluates effectiveness of corrective actions for errors. Conducts monthly quality assurance audits for critical control points and key elements for the systems related to donor suitability, source plasma collection, sample collection, plasma storage, product release, quality assurance, and employee training program. Coordinates management review meetings and participates in center staff meetings. Employee Recruitment and Retention: (5%) Responsible for providing feedback and developing employees in the quality department. Provides feedback during the recruitment process for quality department employees, including performance evaluations and merit increases. Fosters teamwork. Works collaboratively with staff, peers, and management to achieve business goals. Communicates continuously and resolves conflicts proactively. Provides timely feedback on performance and initiates disciplinary action when necessary. Participates in the evaluation and review of center staff. Ensures high levels of customer service and satisfaction. Meets and strives to exceed customer expectations. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Minimum of one-year relevant work experience, or an equivalent combination of education and experience. Relevant work experience within medical or regulated field, highly desirable. Previous work experience within the plasma collection industry is strongly preferred. Computer skills in word processing, excel, data analysis and databases highly desirable. Demonstrated understanding of quality assurance in an FDA-regulated environment. Demonstrated understanding of plasma center operations. Effective organizational, technical and problem-solving skills. Leadership Integrity Fairness Honesty Perseverance Putting the patient at the center Building trust with society Reinforcing our reputation Developing the business Decision-making and Autonomy Responsible for providing exceptional customer service to donors (external) and fellow employees (internal) Refers to Group/Regional Lead for guidance on complex, high-impact or urgent decisions (internal) Refers to management team for escalated donor/employee concerns (internal) Interaction Consults and coordinates directly with the Center Manager on quality concerns within the plasma center. Advises and coordinates will all other center roles to effectively problem solve, mitigate risk, ensure safety of staff and donors, and provide an exceptional customer experience. Attend staff meetings and other team meetings as required. Attention to detail and ability to work independently Effective coaching and counseling skills. Innovation May participate in the management of projects and new initiatives within the center or across centers. Coordinates will all other center roles to effectively problem solve, ensure safety of staff and donors, and provide an exceptional customer experience. Supports the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes as needed, through use of company approved procedures (including but not limited to 5S, Value Stream Mapping and Kaizen). Complexity Maintain general cleanliness of work area and assist other work areas as needed to ensure a clean and professional environment. Production environment oversight. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Essential: High School Diploma or equivalent required. Desired: Associates or Bachelor's degree highly desirable. ADDITIONAL INFORMATION FLSA Classification (US) - Exempt Other duties and responsibilities as assigned. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. W e are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - NY - Latham U. S. Base Salary Range: $67,200. 00 - $92,400. 00 The estimated salary range reflects an anticipated range for this position . T he actual base salary offered may depend on a variety of factors , including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained , certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U. S. based e mployee s may be eligible for s hort -t erm and/or l ong- t erm incentiv e s . U. S. based employees may be eligible to participate in medical, dental , vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U. S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations USA - NY - Latham Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes

This position leads and over-sees the end-to-end Quality Management System (QMS) activities that ensure Animal Health products supplied to the retail market consistently meet regulatory, customer, and company quality standards. This role owns batch acceptance, repackaging quality oversight, product release, temperature-controlled product storage, compliant distribution, and complaint management - driving product integrity, regulatory compliance, and customer trust across the retail supply chain. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Commercial Operations Quality Manager is responsible for the overall management of Commercial Quality USA Animal Health Supplier Management Program from qualification through lifecycle in support of supply chain integrity and continuity, including suppliers, local repackaging operations, internal AST warehouses and 3PL network. This role is responsible for comprehensively evaluating the supplier's regulatory/GXP compliance, investigations, remediation activities, and assessing suitability of Corrective Actions and Preventive Actions (CAPAs). **Duties & Responsibilities** + Own and maintain retail QMS elements (SOPs, Work Instructions, records) covering repackaging, release, storage, and distribution. + Execute quality release of incoming goods and repackaged units per predefined specifications and quality agreements. + Maintain Quality relationship with distribution center(s) and third-party repackaging site, monitoring service-level and quality performance, lead and support investigations and CAPA, ensure inventory is maintained in proper quality status, and initiate continuous improvement activities. + Serve as the quality point of contact for retail customers, addressing quality queries, returns, and complaint trends. + Perform responsibilities of local Management System Owner for assigned quality systems, including writing and maintaining local procedures, training local personnel, actively participating in global network. **Requirements** + Bachelor's degree with focus in pharmaceutical science, veterinary health, chemistry, supply chain, or other related science field. Other bachelor's degree acceptable with relevant experience. + Minimum five (5) years of experience in Pharmaceutical / Animal Health or related field with at least three (3) years of Quality Assurance experience. + Experience within a regulated environment, preferably pharmaceuticals, is desired. + General knowledge of Good Distribution Practices, cGMP, EU, and FDA or USDA regulations. + Possesses excellent communication skills with the ability to influence cross-functional teams as well as work independently. + Excellent oral and written communication skills with the ability to influence cross-functional teams. Attention to detail in a fast-paced, high-volume environment imperative. + Ability to work in a team environment and independently. + Willingness to travel up to 25%. **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

Oversees the quality assurance processes and ensures compliance with industry standards, customer expectations, and regulatory requirements. Collaborates with cross-functional teams to drive continuous improvement initiatives, resolves quality issues, and maintains quality management systems. Responsibilities Maintains the organization's quality standards and ensures compliance with industry regulations and customer requirements. Identifies opportunities for process improvements and collaborates with teams across departments to implement changes that enhance product quality and reduce defects. Reviews and analyzes quality data, including production metrics, testing results, and customer feedback, to identify trends and areas for improvement. Conducts internal audits to ensure that quality processes align with regulatory standards and company policies. Supports external audits and prepares necessary documentation. Investigates quality issues and non-conformances, conducts root cause analysis, and works with relevant teams to implement corrective and preventative actions. Prepares reports, documentation, and quality metrics for internal stakeholders and external regulatory bodies. Ensures that all quality records are properly maintained. Ensures the quality of incoming materials meets company standards and resolves any quality-related issues with suppliers. Performs other duties as assigned. Qualifications Strong knowledge of quality management systems (e.g., ISO 9001, Six Sigma). Excellent problem-solving and analytical skills. Ability to collaborate effectively across multiple departments and external partners. Strong written and verbal communication skills, especially for technical documentation. Knowledge of regulatory and industry standards within the relevant field. Proficient in quality-related software and data analysis tools. Bachelor's degree in engineering, quality management, or a related field, or equivalent education and experience. Experience Requirements: Five years of experience in a quality assurance or quality management role.

If you believe healthcare is a right, that everyone deserves high quality care so they can enjoy their highest level of health and wellbeing, and you value each person's individual story - consider joining us at Neighborhood! We're looking for a highly responsible quality manager who enjoys collaborating with co-workers and is passionate about aligning their work with the organization's mission. About the Role: As the quality manager, you'll develop, implement, and oversee quality improvement initiatives aimed at enhancing patient care outcomes, safety, and satisfaction. Responsibilities include: * Managing quality staff and adhering to standard responsibilities for all managers * Manages the daily operations of the quality assurance and quality improvement program * Facilitates the requirements of the risk management program * Manages quality reporting and data activities You will be primarily based at our Riverway location, 1569 Niagara Street in Buffalo, and will travel to other Neighborhood sites in Western New York as needed. What it's Like to Work at Neighborhood: The top three words employees say describe the work environment are: teamwork, supportive, kind. These are from an anonymous survey of Neighborhood employees for the Buffalo Business First Best Places to Work competition. Neighborhood has earned "finalist" distinction in the competition the last four years. We are a group of flexible and kind individuals who are open to each other's ideas, and see opportunities to innovate and find solutions when challenges arise. Education and Skills to be the Quality Improvement Manager: * Bachelor's degree required. Training in public health preferred. FQHC or similar experience preferred * Experience in quality improvement and risk management required * Able to read, write and speak the English language. A second language of Spanish preferred. What We Offer: Compensation: $78,000-$85,000 per year (based on a full time, 40 hour work week) Individual compensation is based on various factors unique to each candidate, including skill set, experience, qualifications, and other position related components. Benefits: You'll have options for medical, dental, life, and supplemental insurance. We also offer a 403b match, health savings accounts with employer contribution, wellbeing programs, continuing education opportunities, generous paid time off, holidays. About Neighborhood: Neighborhood Health Center is the largest and longest serving Federally Qualified Health Center in Western New York, and is the highest ranked health center for quality in the region. We provide primary and integrated healthcare services all under one roof, regardless of a person's ability to pay. Services include internal/family medicine, pediatrics, OB-GYN, dentistry, podiatry, psychiatry, vision care, nutrition and behavioral health counseling, and pharmacy services. We're working toward a Western New York where all enjoy their highest level of health and wellbeing. Neighborhood Health Center is an equal opportunity employer.

SummaryThe Quality Manager is responsible for the post market surveillance, periodic quality data monitoring using statistical techniques, and risk management processes as well as provides Quality Engineering and Quality Assurance technical expertise and functional support to execute the processes in compliance with applicable regulations including FDA, and international regulations, ISO standards, and any other requirement that apply to the post market surveillance of the products manufactured by BD Urology & Critical Care (UCC).Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Job Responsibilities Manages the post market surveillance (PMS) process including the schedule of product reviews, coordination of updates to documentation, management of actions generated from the reviews and publishes the reviews in the EDMS. Coordinates with R&D, Clinical, Medical Affairs, Regulatory Affairs and Quality to facilitate completion of the PMS reports for each product family. Acts as a technical expert in PMS and risk management. Interfaces with the UCC manufacturing facilities and other business units as required to execute the PMS program and ensure risks are being evaluated and identified, and appropriate controls are being executed. Prepare and implement policies and procedures relating to quality, post market surveillance, risk controls and statistical techniques throughout product lifecycle in compliance with regulations. Ensures the selection, orientation, development, and retention of a sufficient number of qualified staff to carry out the responsibilities of the department. Maintains the integrity of all quality documentation. Responsible to maintain the training requirements for staff, including job position requirements, and evidence of training completion for associates. Responsible to meet quality objective goals as defined annually in support of monthly and quarterly metrics and business strategies. Provide Quality Engineering technical support to assist in resolving quality issues. Participate and have membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the business in an efficient, timely, and accurate manner. Participate in cross-functional team(s) to ensure that PMS, risk, and statistical techniques documentation is prepared and meets new regulatory requirements. Represents UCC in the BD network for PMS, risk and statistical techniques. Interfaces and responds to regulatory agencies as necessary. Oversee the design and implementation of analytical business and technology solutions, i.e., MS Access databases, R, SQL programs, Python, Power BI to support QM Operations. Oversee the use of quality metric data into Quality Management Review Support audits as a Subject Matter Expert for PMS, Risk Management and Statistical Techniques. Education and Experience BS degree required in Engineering, Science, or Technical field, higher education a plus. Minimum of 5 years, 8-10 years preferred of Quality Management System experience in a medical device or pharma or other regulated industry (medical device is preferred). Previous supervisory experience preferred. Experience using analytics / BI packages (e.g., SAS, R, SQL, Cognos, Business Objects, Power BI) to build client analysis solutions is preferred. ASQ, CQE, and CQA Certifications preferred. Knowledge and Skills Experience in data analysis, trending and presenting data in a manner to drive informed decision making. Strong listening, assessment, questioning, analytical and problem-solving skills. Must consistently demonstrate critical thinking skills to manage inputs and outputs. Comprehensive knowledge of quality systems regulations, post market surveillance and risk management. Extensive knowledge of manufacturing Ability to work independently with general direction and concurrence from senior management. Ability to participate and provide leadership to teams and maintain positive work environment. Knowledge, understanding and interpretation of FDA regulations, ISO standards, EU MDR and other industry standards for medical devices is required. Comprehensive knowledge of statistical techniques, investigation techniques, Quality Engineering principles, team functions, leadership techniques and project management methodologies. Ability to effectively manage time and multiple task assignments as well as managing team assignments and direction. Supports a strong culture of accountability and inclusion and seeks to develop team capabilities as well as foster personal growth. Strong interpersonal skills required in areas of verbal/written communications, customer focus, professionalism, coaching, team building, and leading. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Required Skills Optional Skills . Primary Work LocationUSA GA - Covington BMDAdditional LocationsWork ShiftUS BD 1st Shift 8am-430pm (United States of America)

Work Schedule: Monday - Friday, 8:00am - 4:30pm 100% on-site Catalent's 206,878-square-foot Philadelphia-area facility serves as the global Center of Excellence for Clinical Supply Packaging, offering GMP secondary packaging and clinical labeling services. The site provides manual to fully automated packaging solutions, including temperature-controlled options for sensitive products. Come and be part of a team that delivers industry-leading quality and innovation. This position is responsible for being the quality liaison between Philadelphia Quality Assurance and the client. Specific clients will be assigned to each Quality Program Manager with whom they will support and develop a Quality relationship. The Quality Program Manager must be flexible and have well-developed organizational skills and the ability to interact with all levels within the organization. The Role: Work closely with Catalent Philadelphia site to obtain necessary quality information for clients to support their projects and requests Plan, schedule, manage, and host customer, corporate, and internal audits. Support regulatory inspections as required Track audit reporting, drive completion of Catalent response to audit findings, and closure of audit actions Attend project kick-off meetings to assist various departments with understanding the project from a Quality perspective Attend client preparation calls and visits to ensure that the client receives any appropriate documentation requested and get questions answered Act as the primary contact person for client-specific quality questions and be the quality liaison between client and Catalent staff; Act as the primary contact with clients if there are quality questions on documentation, process questions, issues, etc Be knowledgeable about customer-specific requirements. Ensure they are built into the process and communicated to relevant Catalent staff Review deviation and complaint reports and address trends. Prepare communications regarding the results where appropriate and requested Other duties as assigned The Candidate: Bachelor's degree is required, life sciences or scientific degree is preferred Five years of relevant experience working in a pharmaceutical industry or life science industry is required Must possess regulatory and/or client audit experience Must have the ability to present Quality/ Compliance information both internally at Catalent and externally to clients Knowledge of cGMP's is required Why you should join Catalent: Defined career path and annual performance review and feedback process Diverse, inclusive culture Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 152 hours of PTO + 8 paid holidays Generous 401K match Medical, dental and vision benefits Tuition Reimbursement - Let us help you finish your degree or start a new degree! Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

The Manager of Quality Control position is a hands-on role providing support for all aspects of Quality Control for clinical and commercial products. The position will provide expertise in drug substance (API), drug product and device analytical testing. Specifically, the role will provide support to release and stability testing of products, including providing support to investigations related to OOS/OOT results, nonconformances, deviations and other product associated incidents. The role will also oversee or support stability programs related to mid-stage clinical to commercial programs. The position will ensure timely and appropriate analytics activities to meet project target profiles and ICH, USP, FDA, and EMA standards. The Manager will effectively communicate results and issues to peers and management with excellent professional standards. Responsibilities 1. Manager Quality Control operations at contract sites (CDMO, CMO, Laboratories, etc.). Responsibilities include, but may not be limited to: • Managing contract relationships • Managing Contract Approval Forms, Purchase Orders and updates when required • Participating in vetting and selecting appropriate contract testing labs through the Xeris supplier management process • Supporting material qualification processes • Supporting the coordination of testing of raw, intermediate, and final product through the global supply chain • Managing analytical methods validation and transfer to/from contract testing labs • Overseeing release and stability testing operations at contract sites • Ensuring timely and appropriate analytics activities to meet project target profiles and ICH, USP, FDA, and EMA standards • Manage/validate SLIMstat software and trend manufacturing/stability data • Participating in the preparation of analytical, testing, and specification sections of regulatory submissions and communications • Adhering to CMC/QC budgets 2. Support Mid/late Stage clinical and commercial stability programs. Responsibilities include, but may not be limited to: • Supporting the clinical stability programs for Xeris mid-to-late stage products • Supporting the commercial stability programs for Xeris commercial products • Managing stability sample storage and testing at contract sites • Managing API retain and reference standard storage • Participating in the preparation of stability sections for drug substance and drug product sections of regulatory submissions Qualifications • Bachelor's/Master's degree in biology, chemistry, or similar discipline and 5+ years of experience working with pharmaceuticals/biopharmaceuticals, or Ph.D. and 5+ years' experience • A minimum of 5 years in a supervisor or manager role in a GMP pharmaceutical/biopharmaceutical environment, including knowledge of analytical requirements for clinical-phase and commercial products • Experience in Quality Controls and analytical method validation operations • Solid understanding of Quality Systems in support of investigations and quality events • Ability to effectively work with R&D scientists, CMC engineers, Supply Chain, Regulatory Affairs, and Quality Assurance functions • Proficient with Microsoft Word, PowerPoint, Outlook, and Excel, as well as web-based software for various applications • Experience in the use and application of statistical software. For example, SLIM, JMP, etc. • Competencies: Teamwork & Collaboration, Attention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Project Management, Adaptability, Professionalism, Written and Verbal Communications, Presentation skills • Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. This is a hybrid role based in Xeris' Chicago office and requires a minimum of three days per week in the office. On-site requirements may change at management's discretion. The level of the position will be determined based on the selected candidate's qualifications and experience. #LI-HYBRID As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. The anticipated base salary range for this position is $110,000 to $160,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

The Manager of Quality Control position is a hands-on role providing support for all aspects of Quality Control for clinical and commercial products. The position will provide expertise in drug substance (API), drug product and device analytical testing. Specifically, the role will provide support to release and stability testing of products, including providing support to investigations related to OOS/OOT results, nonconformances, deviations and other product associated incidents. The role will also oversee or support stability programs related to mid-stage clinical to commercial programs. The position will ensure timely and appropriate analytics activities to meet project target profiles and ICH, USP, FDA, and EMA standards. The Manager will effectively communicate results and issues to peers and management with excellent professional standards. **Responsibilities** 1. Manager Quality Control operations at contract sites (CDMO, CMO, Laboratories, etc.). Responsibilities include, but may not be limited to: - Managing contract relationships - Managing Contract Approval Forms, Purchase Orders and updates when required - Participating in vetting and selecting appropriate contract testing labs through the Xeris supplier management process - Supporting material qualification processes - Supporting the coordination of testing of raw, intermediate, and final product through the global supply chain - Managing analytical methods validation and transfer to/from contract testing labs - Overseeing release and stability testing operations at contract sites - Ensuring timely and appropriate analytics activities to meet project target profiles and ICH, USP, FDA, and EMA standards - Manage/validate SLIMstat software and trend manufacturing/stability data - Participating in the preparation of analytical, testing, and specification sections of regulatory submissions and communications - Adhering to CMC/QC budgets 2. Support Mid/late Stage clinical and commercial stability programs. Responsibilities include, but may not be limited to: - Supporting the clinical stability programs for Xeris mid-to-late stage products - Supporting the commercial stability programs for Xeris commercial products - Managing stability sample storage and testing at contract sites - Managing API retain and reference standard storage - Participating in the preparation of stability sections for drug substance and drug product sections of regulatory submissions **Qualifications** - Bachelor's/Master's degree in biology, chemistry, or similar discipline and 5+ years of experience working with pharmaceuticals/biopharmaceuticals, or Ph.D. and 5+ years' experience - A minimum of 5 years in a supervisor or manager role in a GMP pharmaceutical/biopharmaceutical environment, including knowledge of analytical requirements for clinical-phase and commercial products - Experience in Quality Controls and analytical method validation operations - Solid understanding of Quality Systems in support of investigations and quality events - Ability to effectively work with R&D scientists, CMC engineers, Supply Chain, Regulatory Affairs, and Quality Assurance functions - Proficient with Microsoft Word, PowerPoint, Outlook, and Excel, as well as web-based software for various applications - Experience in the use and application of statistical software. For example, SLIM, JMP, etc. -Competencies: Teamwork & Collaboration, Attention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Project Management, Adaptability, Professionalism, Written and Verbal Communications, Presentation skills -Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. This is a hybrid role based in Xeris' Chicago office and requires a minimum of three days per week in the office. On-site requirements may change at management's discretion. The level of the position will be determined based on the selected candidate's qualifications and experience. \#LI-HYBRID As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. The anticipated base salary range for this position is $110,000 to $160,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. **Job Locations** _US-IL-Chicago_ **Title** _Manager, Quality Control_ **ID** _2026-2330_ **Category** _Quality Control_ **Type** _Full-Time_

Company Information Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,200 experts servicing global clients from North America and European sites, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. At Cambrex, our people set us apart. We're committed to attracting, nurturing, and retaining a passionate and talented team of valued experts in our fast-paced and growing company. We offer an exceptional benefits package including medical, dental, vision, Life, LTD, generous vacation in your first year, sick time, and retirement savings! Known for our scientific and manufacturing excellence, as well as our strong customer focus, we offer a range of career opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Job Overview Come join our QC team of experts. This role will manage and direct Quality Control scientific staff. Focus efforts of self and team on analytical support with analytical activities involving the stability and reference standard programs. Enhance efficiency of current systems. Mentor and develop team members. Seek innovative cost and scientific solutions. Ensure compliance with applicable Company SOPs and regulatory guidelines. Responsibilities Manage/coordinate/drive efforts of staff in stability plan design and coordinating the activities that support the entire stability lifecycle of the study. Manage/coordinate/drive efforts of staff in the design of stability protocols and reports in accordance with ICH guidelines and publishing in MasterControl with adherence to associated SOPs. Manage/coordinate stability study set down to fraction and stage materials. Track/monitor all active stability programs including pull dates and report issue dates. Ensure stability inventory is correct and up to date. Manage/coordinate/drive efforts for reference standard management and retesting program. Track/monitor all current reference standards to plan for the testing and timely delivery of certificates. Provide training/development for specified laboratory staff on the stability and reference standard program. Routinely represents the department on stability and reference standard topics in internal or external meetings, with clients, and during audits. Assure compliant, staffed analytical laboratory support. Write deviations, assist/lead laboratory investigations, and assist in CAPAs relative to stability and reference standard program. Recommend/justify new/additional equipment, staffing or organizational positions, promotions. Qualifications/Skills Excellent verbal and written communication and interpersonal skills, problem-solving, and organizational skills. Track record of successfully applying high level judgment in a variety of complex and unprecedented situations. Proven ability to act independently to achieve pre-determined goals and objectives and obtain desired results. Ability to coach and develop staff and to transfer job knowledge and skills. Ability to integrate input/data from diverse sources and create new and innovative solutions. Demonstrated ability to apply technical, functional, and industry knowledge to design and execute projects that shape the strategic direction of one or more projects. Other demonstrated abilities: work in a diverse team environment; foresight and judgment in planning, organizing, and guiding complex projects; making complex decisions and troubleshooting in ambiguous situations. Exposure to broader analytical techniques (i. e. , beyond just USP compendial testing). Education, Experience & Licensing Requirements BS, MS, or PhD in Chemistry (or closely related discipline). A minimum of at least 7 plus years' experience in QC (or similar role) with 2 plus years' experience managing others in a laboratory environment (prefer in a GMP/QC-compliant pharmaceutical laboratory environment) with focus on ICH stability testing. Strong Quality Control, compliance, scheduling, and organizational skills and insight. Expertise in most common analytical techniques/technologies (e. g. , HPLC, GC, LC/GC/MS, IR, Empower, etc). Expertise in USP compendial and other technical application testing and in OOS investigations. Expertise in creating and interpreting SOPs. Ability to function as technical expert/consultant. Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. #LI-RD1 Sedentary work, exerting up to 10 pounds of force occasionally, and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. The daily work is performed in an office setting and involves sitting most of the time. Walking and standing are required only occasionally. Knowledge of working with hazardous chemicals. Position also requires visual acuity, talking, writing, and typing. BS, MS, or PhD in Chemistry (or closely related discipline). A minimum of at least 7 plus years' experience in QC (or similar role) with 2 plus years' experience managing others in a laboratory environment (prefer in a GMP/QC-compliant pharmaceutical laboratory environment) with focus on ICH stability testing. Strong Quality Control, compliance, scheduling, and organizational skills and insight. Expertise in most common analytical techniques/technologies (e. g. , HPLC, GC, LC/GC/MS, IR, Empower, etc). Expertise in USP compendial and other technical application testing and in OOS investigations. Expertise in creating and interpreting SOPs. Ability to function as technical expert/consultant. Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. #LI-RD1Manage/coordinate/drive efforts of staff in stability plan design and coordinating the activities that support the entire stability lifecycle of the study. Manage/coordinate/drive efforts of staff in the design of stability protocols and reports in accordance with ICH guidelines and publishing in MasterControl with adherence to associated SOPs. Manage/coordinate stability study set down to fraction and stage materials. Track/monitor all active stability programs including pull dates and report issue dates. Ensure stability inventory is correct and up to date. Manage/coordinate/drive efforts for reference standard management and retesting program. Track/monitor all current reference standards to plan for the testing and timely delivery of certificates. Provide training/development for specified laboratory staff on the stability and reference standard program. Routinely represents the department on stability and reference standard topics in internal or external meetings, with clients, and during audits. Assure compliant, staffed analytical laboratory support. Write deviations, assist/lead laboratory investigations, and assist in CAPAs relative to stability and reference standard program. Recommend/justify new/additional equipment, staffing or organizational positions, promotions.