Quality manager jobs in Lexington, KY - 42 jobs

Datavant is a data platform company and the world's leader in health data exchange. Our vision is that every healthcare decision is powered by the right data, at the right time, in the right format. Our platform is powered by the largest, most diverse health data network in the U.S., enabling data to be secure, accessible and usable to inform better health decisions. Datavant is trusted by the world's leading life sciences companies, government agencies, and those who deliver and pay for care. By joining Datavant today, you're stepping onto a high-performing, values-driven team. Together, we're rising to the challenge of tackling some of healthcare's most complex problems with technology-forward solutions. Datavanters bring a diversity of professional, educational and life experiences to realize our bold vision for healthcare. Datavant is seeking a strategic and hands-on **Director of Quality** to lead product and supplier quality assurance efforts within our **Life Sciences business unit** , which includes the **Datavant Connect** and **Aetion Evidence Platform** . These platforms deliver regulatory-grade real-world data (RWD) solutions through tokenization, data linkage, and privacy-preserving analytics. As Director of Quality, you will own the implementation and evolution of GxP-aligned quality practices that support regulated data services and software. This includes oversight of software validation, privacy compliance, supplier qualification, and audit readiness. You will also lead a team of quality specialists and partner cross-functionally with Product, Engineering, Security, Privacy, and Customer Assurance to ensure that we meet or exceed regulatory expectations and customer trust standards. This role is essential to operationalizing Datavant's **Quality Management System (QMS)** across internal and external stakeholders and enabling continued growth in regulated RWD and evidence generation environments. **What You Will Do** + Lead the development and continuous improvement of Datavant's QMS across Life Sciences products and supplier relationships, ensuring GxP and privacy compliance. + Manage and mentor a team of quality specialists responsible for core functions such as CAPA, internal audits, validation, and supplier monitoring. + Serve as the primary quality liaison to product development teams (Connect and Aetion), providing guidance on SDLC quality controls, validation strategies (GAMP 5, Part 11), and regulatory risk mitigation. + Oversee supplier qualification and re-evaluation processes, including risk-based assessments, audit coordination, and performance monitoring. + Establish and maintain quality metrics (e.g., CAPA closure, audit readiness scores, supplier performance) and drive continuous improvement initiatives. + Support readiness for and participation in customer audits and external assessments (e.g., pharma clients, CROs, regulatory partners). + Partner with Security and Privacy teams to align product and supplier practices with frameworks like HIPAA, GDPR, and FedRAMP. + Lead or support periodic management reviews of the QMS and contribute to strategic quality planning and resource allocation. + Ensure clear documentation and traceability across all quality activities, systems, and changes in compliance with FDA 21 CFR Part 11 and ICH E6(R3). + Represent Datavant's quality program in external communications, including client onboarding, RFIs, and quality-related escalations. **What You Need to Succeed** + 8+ years of experience in quality, compliance, or regulatory roles within life sciences, digital health, or regulated software organizations. + Strong working knowledge of relevant regulations and frameworks, including **FDA 21 CFR Part 11, GAMP 5, ISO 9001, ICH E6(R3), HIPAA** , and **GDPR** . + Proven leadership in scaling and operationalizing a **QMS in a SaaS, RWD, or GxP context** . + Experience managing and mentoring cross-functional teams. + Demonstrated success overseeing **validation, supplier oversight, internal audits, and CAPA management** . + Deep understanding of **data governance, privacy, and security** best practices. + Experience interacting with external auditors, customer compliance teams, or regulatory agencies. + Strong communication skills-capable of explaining complex quality topics to product, legal, technical, and customer-facing stakeholders. **What Helps You Stand Out** + Prior experience supporting real-world data (RWD) platforms or evidence generation technologies used in regulatory submissions. + Background working in or with tokenization, health data linkage, or privacy-enhancing technologies. + Experience interfacing directly with pharmaceutical, biotech, or CRO quality teams. + Training or certification in Six Sigma, ISO Auditing, or software validation methodologies. + Familiarity with supplier portals, quality dashboards, or eQMS platforms (e.g., Veeva, MasterControl). + Experience contributing to industry working groups on quality, data integrity, or health data compliance. \#LI-BC1 We are committed to building a diverse team of Datavanters who are all responsible for stewarding a high-performance culture in which all Datavanters belong and thrive. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. At Datavant our total rewards strategy powers a high-growth, high-performance, health technology company that rewards our employees for transforming health care through creating industry-defining data logistics products and services. The range posted is for a given job title, which can include multiple levels. Individual rates for the same job title may differ based on their level, responsibilities, skills, and experience for a specific job. This role is eligible for additional variable compensation. The estimated base salary range (not including variable pay) for this role is: $165,000-$230,000 USD To ensure the safety of patients and staff, many of our clients require post-offer health screenings and proof and/or completion of various vaccinations such as the flu shot, Tdap, COVID-19, etc. Any requests to be exempted from these requirements will be reviewed by Datavant Human Resources and determined on a case-by-case basis. Depending on the state in which you will be working, exemptions may be available on the basis of disability, medical contraindications to the vaccine or any of its components, pregnancy or pregnancy-related medical conditions, and/or religion. This job is not eligible for employment sponsorship. Datavant is committed to a work environment free from job discrimination. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. To learn more about our commitment, please review our EEO Commitment Statement here (************************************************** . Know Your Rights (*********************************************************************** , explore the resources available through the EEOC for more information regarding your legal rights and protections. In addition, Datavant does not and will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay. At the end of this application, you will find a set of voluntary demographic questions. If you choose to respond, your answers will be anonymous and will help us identify areas for improvement in our recruitment process. (We can only see aggregate responses, not individual ones. In fact, we aren't even able to see whether you've responded.) Responding is entirely optional and will not affect your application or hiring process in any way. Datavant is committed to working with and providing reasonable accommodations to individuals with physical and mental disabilities. If you need an accommodation while seeking employment, please request it here, (************************************************************** Id=**********48790029&layout Id=**********48795462) by selecting the 'Interview Accommodation Request' category. You will need your requisition ID when submitting your request, you can find instructions for locating it here (******************************************************************************************************* . Requests for reasonable accommodations will be reviewed on a case-by-case basis. For more information about how we collect and use your data, please review our Privacy Policy (**************************************** .

is contingent upon contract award.** **Key Responsibilities** + Develop and implement the SOF GLSS quality management strategy in alignment with contract requirements and USSOCOM objectives. + Lead Quality Assurance and Quality Control teams across multiple CONUS and OCONUS sites. + Ensure compliance with applicable standards and regulations, including ISO 9001, AS9100, DCMA, DoD, and USSOCOM directives. + Oversee internal and external audits, government surveillance activities, and corrective action processes. + Establish and monitor key performance indicators (KPIs) tied to contract deliverables and readiness metrics. + Collaborate with engineering, logistics, supply chain, and program management teams to resolve quality issues and enhance system reliability. + Manage document control, training programs, and quality certifications across the SOF GLSS enterprise. + Serve as the primary interface with USSOCOM quality representatives, DCMA, and other oversight entities. + Lead root cause analysis and continuous improvement initiatives focused on lifecycle sustainment and field support. + Promote a culture of quality and compliance through proactive leadership, communication, and training. **** **Qualifications** + Bachelor's degree in Engineering, Quality Management, or related field (Master's preferred). + 10+ years of progressive experience in quality assurance/control, with at least 5 years in a leadership role supporting DoD or federal contracts. + Strong knowledge of DoD acquisition regulations, FAR/DFARS, and government quality oversight practices. + Proven experience with CAPA, Six Sigma, Lean, and performance-based logistics (PBL) environments. + Excellent leadership, communication, and stakeholder engagement skills. + Experience with ERP systems and quality management platforms (e.g., AS9100-compliant systems). **** **Preferred Certifications** + Certified Quality Auditor (CQA) + Certified Manager of Quality/Organizational Excellence (CMQ/OE) + Six Sigma Black Belt or Lean Certification + ASQ or equivalent professional membership + Familiarity with DCMA surveillance protocols and government audit readiness **Employee benefits include the following:** + Healthcare coverage + Life insurance, AD&D, and disability benefits + Retirement plan + Wellness programs + Paid time off, including holidays and leave of absences + Eligible Tuition Reimbursement + Learning and Development resources + Employee assistance resources _Pay and benefits are subject to change at any time and may be modified at the discretion of the company, consistent with the terms of any applicable compensation or benefit plans._ 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.

is contingent upon contract award. Key Responsibilities Develop and implement the SOF GLSS quality management strategy in alignment with contract requirements and USSOCOM objectives. Lead Quality Assurance and Quality Control teams across multiple CONUS and OCONUS sites. Ensure compliance with applicable standards and regulations, including ISO 9001, AS9100, DCMA, DoD, and USSOCOM directives. Oversee internal and external audits, government surveillance activities, and corrective action processes. Establish and monitor key performance indicators (KPIs) tied to contract deliverables and readiness metrics. Collaborate with engineering, logistics, supply chain, and program management teams to resolve quality issues and enhance system reliability. Manage document control, training programs, and quality certifications across the SOF GLSS enterprise. Serve as the primary interface with USSOCOM quality representatives, DCMA, and other oversight entities. Lead root cause analysis and continuous improvement initiatives focused on lifecycle sustainment and field support. Promote a culture of quality and compliance through proactive leadership, communication, and training. 🔹 Qualifications Bachelor's degree in Engineering, Quality Management, or related field (Master's preferred). 10+ years of progressive experience in quality assurance/control, with at least 5 years in a leadership role supporting DoD or federal contracts. Strong knowledge of DoD acquisition regulations, FAR/DFARS, and government quality oversight practices. Proven experience with CAPA, Six Sigma, Lean, and performance-based logistics (PBL) environments. Excellent leadership, communication, and stakeholder engagement skills. Experience with ERP systems and quality management platforms (e.g., AS9100-compliant systems). 🔹 Preferred Certifications Certified Quality Auditor (CQA) Certified Manager of Quality/Organizational Excellence (CMQ/OE) Six Sigma Black Belt or Lean Certification ASQ or equivalent professional membership Familiarity with DCMA surveillance protocols and government audit readiness Employee benefits include the following: Healthcare coverage Life insurance, AD&D, and disability benefits Retirement plan Wellness programs Paid time off, including holidays and leave of absences Eligible Tuition Reimbursement Learning and Development resources Employee assistance resources Pay and benefits are subject to change at any time and may be modified at the discretion of the company, consistent with the terms of any applicable compensation or benefit plans.

This position is contingent upon contract award. Key Responsibilities * Develop and implement the SOF GLSS quality management strategy in alignment with contract requirements and USSOCOM objectives. * Lead Quality Assurance and Quality Control teams across multiple CONUS and OCONUS sites. * Ensure compliance with applicable standards and regulations, including ISO 9001, AS9100, DCMA, DoD, and USSOCOM directives. * Oversee internal and external audits, government surveillance activities, and corrective action processes. * Establish and monitor key performance indicators (KPIs) tied to contract deliverables and readiness metrics. * Collaborate with engineering, logistics, supply chain, and program management teams to resolve quality issues and enhance system reliability. * Manage document control, training programs, and quality certifications across the SOF GLSS enterprise. * Serve as the primary interface with USSOCOM quality representatives, DCMA, and other oversight entities. * Lead root cause analysis and continuous improvement initiatives focused on lifecycle sustainment and field support. * Promote a culture of quality and compliance through proactive leadership, communication, and training. Qualifications * Bachelor's degree in Engineering, Quality Management, or related field (Master's preferred). * 10+ years of progressive experience in quality assurance/control, with at least 5 years in a leadership role supporting DoD or federal contracts. * Strong knowledge of DoD acquisition regulations, FAR/DFARS, and government quality oversight practices. * Proven experience with CAPA, Six Sigma, Lean, and performance-based logistics (PBL) environments. * Excellent leadership, communication, and stakeholder engagement skills. * Experience with ERP systems and quality management platforms (e.g., AS9100-compliant systems). Preferred Certifications * Certified Quality Auditor (CQA) * Certified Manager of Quality/Organizational Excellence (CMQ/OE) * Six Sigma Black Belt or Lean Certification * ASQ or equivalent professional membership * Familiarity with DCMA surveillance protocols and government audit readiness Employee benefits include the following: * Healthcare coverage * Life insurance, AD&D, and disability benefits * Retirement plan * Wellness programs * Paid time off, including holidays and leave of absences * Eligible Tuition Reimbursement * Learning and Development resources * Employee assistance resources Pay and benefits are subject to change at any time and may be modified at the discretion of the company, consistent with the terms of any applicable compensation or benefit plans.

The Manager, Data Quality, is responsible for overseeing the full data management lifecycle and operational workflow of Company Entity Management (CEM) for company and contact data within Dodge Construction Network's (Dodge) master data ecosystem. This role leads both onshore and offshore teams to ensure the accuracy, completeness, and standardization of company entities that power Dodge's products, customer experiences, and analytics. The Manager will define and execute the end-to-end operating model for CEM including the development of Standard Operating Procedures (SOPs), establishing KPIs, designing quality and governance frameworks, and defining requirements for automation and human-in-the-loop workflows. This role drives continuous improvement by refining processes, enhancing data sourcing and enrichment, evaluating automation outputs, and collaborating closely with cross-functional partners across Product, Engineering, and Operations. This leader must bring strong people management and project management skills, an analytical mindset, and have experience working in scalable data operations environments. This is a full-time position and reports directly to the Director of Data Acquisition. **_Preferred Location_** + This is a remote, home-office-based role, and candidates located in the continental United States will be considered. + For this position, there is a preference to hire in the Central and Eastern Time Zone; however, candidates in other areas/time zones would be considered as well. **_Travel Requirements_** Expected travel is minor for this role. **_Essential Functions_** + Design, maintain, and improve company and contact entity workflows, SOPs, SLAs, and quality standards + Define and track KPIs for team efficiency, business impact, financial stewardship, and client satisfaction + Oversee entity creation, updates, merges, conflict resolution, and exception handling + Partner with automation, engineering, and data science to integrate and optimize human-in-the-loop and machine-assisted processes + Analyze performance patterns to identify automation gaps, reduce manual interventions, and continuously improve processes + Lead, mentor, and develop CEM team members + Establish performance expectations, work allocation, and capacity planning + Manage relationships with third party data providers and offshore vendors + Collaborate closely with Engineering, Product, Sourcing, and Sales to align CEM standards with business and platform needs + Participate in roadmap discussions, attribute model design, and classification/taxonomy updates **_Education Requirement_** Bachelor's degree in Information Systems, Data Analytics, Supply Chain Management, Computer Science, Engineering, Operational Management, or related technical fields or equivalent education and work experience. **_Required Experience, Knowledge and Skills_** + 7+ years of experience in data operations, master data management, digital operations, or business transformation + 2+ years managing teams + Proven experience managing both onshore and offshore teams + Experience with SQL and/or Python programming + Advanced problem solving and data driven decision making capabilities + Proven record of managing external vendor relationships + Ability to translate technical concepts into actional business insights for non-technical stakeholders + Experience with automation tools, scraping frameworks, and data pipelines + Exposure to data operations utilizing machine learning and data enrichment techniques + Proficiency in data governance, KPI management, and quality assurance + Strong project management skills, including planning, prioritization, and execution of change management + Excellent written and verbal communication skills for presenting strategies, reporting performance metrics, and building relationships with stakeholders **_Preferred Experience, Knowledge and Skills_** + Data Visualization tools such as AWS Quicksight, PowerBI, Tableau + Knowledge of construction industry or content workflows a plus + Experience with salesforce a plus + Familiarity with cloud-based data environments + Familiarity with Jira/Confluence **_About Dodge Construction Network_** Dodge Construction Network exists to deliver the comprehensive data and connections the construction industry needs to build thriving communities. Our legacy is deeply rooted in empowering our customers with transformative insights, igniting their journey towards unparalleled business expansion and success. We serve decision-makers who seek reliable growth and who value relationships built on trust and quality. By combining our proprietary data with cutting-edge software, we deliver to our customers the essential intelligence needed to excel within their respective landscapes. We propel the construction industry forward by transforming data into tangible guidance, driving unparalleled advancement. Dodge is the catalyst for modern construction. **_Salary Disclosure_** Dodge Construction Network's compensation and rewards package for full time roles includes a market competitive salary, comprehensive benefits, and, for applicable roles, uncapped commissions plans or an annual discretionary performance bonus. **_For this role, we are only considering candidates who are legally authorized to work in the United States and who do not now or in the future require sponsorship for employment visa status._** **_A background check is required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job and consistent with all federal state and local ordinances._** **_Reasonable Accommodation_** **_Dodge Construction Network is committed to recruiting, hiring, and promoting people with disabilities. If you need an accommodation or assistance completing the online application, please email_** **_***************************_** **_._** **_Equal Employment Opportunity Statement_** **_Dodge Construction Network is an Equal Opportunity Employer. We are committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. All employment decisions shall be based on merit, qualifications, and business needs without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law._** \#LI-Remote \#LI-CS1 \#DE-Remote \#DE-2026-22

The Quality Manager is responsible for leading all quality systems within the manufacturing operation to ensure consistent product quality, compliance, and continuous improvement. This role drives quality strategy, develops and maintains effective processes, and partners closely with operations to reduce defects, improve efficiency, and strengthen accountability across the plant.

Meta is seeking an experienced Building Management System (BMS) Quality Manager to join our Data Center Engineering & Construction (DEC) Quality team. Our team's mission is to optimize the delivery of our Building Management Systems to ensure it is completed on time, is safe, robust, reliable, and conforms to our design and quality requirements. Role will be supporting internal cross-functional teams, lead installation and commissioning efforts, oversee quality, and quickly adapt in an evolving space.Our data centers are the foundation upon which our rapidly growing infrastructure efficiently operates, and our innovative services are delivered. Building and operating data centers the "right" way is synonymous with ensuring high uptime, capacity availability and capital conservation. The data center engineering team thinks from chip to chiller (or electrical substation), determining configurations and ensuring maximum efficiency of our compute infrastructure. **Required Skills:** BMS Quality Manager (BQM) - Data Center Design, Engineering and Construction Responsibilities: 1. Manage, onboard, and lead the General Contractor BMS Lead(s), the Control Systems Integrator (CSI) and Electrical and Installation (E&I) controls contractor s throughout all phases of the project, while developing efficiency improvements and incorporating lessons learned to ensure a safe, robust, reliable and functional controls system that adheres to Meta's design and quality requirements 2. Establish a clear vision and foster cross-functional collaboration, coordination, and support among on-site project teams, including the Meta BMS team, general contractors, Control System Integrators, and installation contractors 3. Drive consistency and standardization across all buildings and Control System Integrators and installation contractors 4. Review, understand and ensure project level adherence to the issued revision of the BMS PLC Playbook 5. Perform BMS inspections (wiring, installation, and commissioning) and validate the status/progress of the projects including supporting the project teams, both internal and external, starting from the early stages of Mechanical, Electrical and Plumbing (MEP) construction by working with project level Construction Managers (both internal and external) to check the health of the project (including schedule), working with the project teams and supporting Regional Quality Managers (RQMs). Align internally on program/project related communications to ensure a clear, consistent message to trade partners 6. Assess team performance, build relationships and to support the project benchmark and mock-up process of the BMS installations to assure consistency across the project while coordinating these efforts across multiple cross-functional partners, in a timely manner, to minimize re-work 7. Work with Construction Managers, Regional Quality Managers and General Contractors to ensure creation, accuracy and maintenance of logical schedule(s) for construction, commissioning, and packaged equipment BMS activities while leveraging this data to identify early finish dates for detailed design delivery 8. Coordinate and manage both packaged equipment factory installed controls audits and BMS commissioning audits to ensure specification/requirement adherence and track identified deficiencies through completion 9. Coordinate and lead large multi-stakeholder meetings on a regular basis and communicate discussions to all key stakeholders 10. Support custom tooling and their integration into the construction processes as well as supporting other cross-functional program/project initiatives that directly impact the delivery of the BMS while simultaneously working to identify and mitigate risk associated with these efforts 11. Travel domestically as needed (anticipated 40-50% travel) **Minimum Qualifications:** Minimum Qualifications: 12. Bachelor's degree (Engineering, Construction Management, or equivalent degree) or relevant work experience 13. 10+ years of experience with a combination of Instrumentation and Controls programming/installation, general contractor MEP coordination/project management, commissioning (both mechanical and electrical) of data centers, or other large scale mission critical buildings 14. Experience with Industrial Automation and Building Management Control Systems (i.e. PLC/DDC) 15. 3+ years of experience with programming/designing of HVAC control systems & Electrical Power Monitoring **Preferred Qualifications:** Preferred Qualifications: 16. Experience with PLC, SCADA and OPC UA systems 17. Experience with Schneider Electric Unity Pro, AVEVA, and Ignition platforms 18. Experience with Schneider Modicon and Rockwell Allen-Bradley PLC Platforms 19. Experience with Autodesk ACC Build and Procore Platforms 20. Certified in the following: cGMP, CAP (Certified Automation Professional), and/or PMP (Project Management Professional) **Public Compensation:** $150,000/year to $209,000/year + bonus + equity + benefits **Industry:** Internet **Equal Opportunity:** Meta is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender, gender identity, gender expression, transgender status, sexual stereotypes, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. We also consider qualified applicants with criminal histories, consistent with applicable federal, state and local law. Meta participates in the E-Verify program in certain locations, as required by law. Please note that Meta may leverage artificial intelligence and machine learning technologies in connection with applications for employment. Meta is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know at accommodations-ext@meta.com.

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**Who Are We?** Taking care of our customers, our communities and each other. That's the Travelers Promise. By honoring this commitment, we have maintained our reputation as one of the best property casualty insurers in the industry for over 170 years. Join us to discover a culture that is rooted in innovation and thrives on collaboration. Imagine loving what you do and where you do it. **Job Category** Technology **Compensation Overview** The annual base salary range provided for this position is a nationwide market range and represents a broad range of salaries for this role across the country. The actual salary for this position will be determined by a number of factors, including the scope, complexity and location of the role; the skills, education, training, credentials and experience of the candidate; and other conditions of employment. As part of our comprehensive compensation and benefits program, employees are also eligible for performance-based cash incentive awards. **Salary Range** $52,600.00 - $86,800.00 **Target Openings** 1 **What Is the Opportunity?** At Travelers, the Operations Quality Assurance (QA) groups are responsible for ensuring that a high-level of customer experience is being provided to our external customers and internal business partners. As a Sr Quality Assurance Specialist, you will be responsible for assessing interactions and/or transactions of other internal employee groups to ensure that the predetermined quality standards are being met. As you expand your technical skills and business knowledge, you will have the opportunity to grow your career at Travelers. **What Will You Do?** + Perform quality reviews for supported business area(s), adhering to Quality program guidelines and audit standards, to ensure accuracy. + Assist in the onboarding and training of less experienced team members. + Participate in quality assurance meetings and discussions. + Provide recommendations to improve quality assurance processes, including, but not limited to, program attributes. + Build and maintain knowledge and understanding of products, forms, coverages, workflows, and quality assurance processes for primary business area(s) supported. + Embrace change management efforts. + Perform other responsibilities as assigned. **What Will Our Ideal Candidate Have?** + _Two years of Premium Audit, and Business Insurance experience_ + _Ability to work on high-volume tasks simultaneously to ensure their timely, accurate, and high-quality completion._ + _Attention to detail, with a focus on producing quality, error-free work._ + _Written and verbal communication skills with the ability to collaborate across business areas._ **What is a Must Have?** + High school diploma or equivalent. + One year of insurance, operations, or related experience. **What Is in It for You?** + **Health Insurance** : Employees and their eligible family members - including spouses, domestic partners, and children - are eligible for coverage from the first day of employment. + **Retirement:** Travelers matches your 401(k) contributions dollar-for-dollar up to your first 5% of eligible pay, subject to an annual maximum. If you have student loan debt, you can enroll in the Paying it Forward Savings Program. When you make a payment toward your student loan, Travelers will make an annual contribution into your 401(k) account. You are also eligible for a Pension Plan that is 100% funded by Travelers. + **Paid Time Off:** Start your career at Travelers with a minimum of 20 days Paid Time Off annually, plus nine paid company Holidays. + **Wellness Program:** The Travelers wellness program is comprised of tools, discounts and resources that empower you to achieve your wellness goals and caregiving needs. In addition, our mental health program provides access to free professional counseling services, health coaching and other resources to support your daily life needs. + **Volunteer Encouragement:** We have a deep commitment to the communities we serve and encourage our employees to get involved. Travelers has a Matching Gift and Volunteer Rewards program that enables you to give back to the charity of your choice. **Employment Practices** Travelers is an equal opportunity employer. We value the unique abilities and talents each individual brings to our organization and recognize that we benefit in numerous ways from our differences. In accordance with local law, candidates seeking employment in Colorado are not required to disclose dates of attendance at or graduation from educational institutions. If you are a candidate and have specific questions regarding the physical requirements of this role, please send us an email (*******************) so we may assist you. Travelers reserves the right to fill this position at a level above or below the level included in this posting. To learn more about our comprehensive benefit programs please visit ******************************************************** .

Menasha Corporation Employees, please log-in to your Workday account to apply for positions. ABOUT US (AND OUR EXCITING FUTURE) Menasha Corporation is all about possibilities. Our two businesses, Menasha Packaging and ORBIS Corporation, are leaders in their industries, providing corrugated and plastic packaging products and related services to major global companies. Our employees make the difference, proving that great ideas, collaboration and quality turn possibilities into success. Working at Menasha Corporation means that your insights provide cutting-edge solutions for our customers. If you like to make things happen and are passionate about what you do, you're going to want to be here. Join us and become part of the power behind possible. About The Opportunity We're hiring a Quality Auditor to join our Team. In this position you will perform product and process audits, assist in corrective actions and update documents within the Quality Management System (QMS) to ensure customer satisfaction. This is your chance to grow with a family-owned company that values safety, teamwork, and career development. Why ORBIS? At ORBIS, we prioritize our employees' well-being and satisfaction. After 30 days of employment, you'll be eligible for a comprehensive benefits package that includes Medical, Dental and Vision Insurance 401K with Company Match Annual Incentive Plan And much more! We also provide a safe work environment and a family-friendly work schedule, ensuring a healthy work-life balance. Key Duties and Responsibilities: Support plant personnel on daily quality concerns and issue and communicate quality alerts, as needed. Audit compliance with existing procedures and requirements, including paperwork at the press and process variances. Perform raw material testing, prepare trend analysis to evaluate vendors and update receiving inspection instruction per vendor. Audit finished good and report findings to production and quality personnel. Support correlation studies and conduct in-house calibration and schedule outsourcing calibration services. Support the QMS by updating documentation and aid in writing procedures and work instructions. Work in a safe and efficient manner using all personal protective, safety equipment and devices that are required. Knowledge of Microsoft Office and other computer programs Willing to work alternate shifts as needed and be familiar with all job tasks in the department Strong attention to detail Work Experience: 1-3 years of quality experience Shift Hours and Schedule: 7:00pm-7:00am 2/2/3 Schedule Two companies, one vision. Menasha Corporation consists of two companies that are leading the way to a sustainable future with packaging and supply chain solutions. Founded in 1849 and headquartered in Neenah, Wisconsin, we employ over 7,500 employees in 112 facilities in North America and Europe. Our companies are leading corrugated and plastic packaging manufacturers and supply chain solution providers. Our Menasha Packaging Company is the largest independent provider of packaging and supply chain service solutions in North America, designing, printing, and fulfilling graphic packaging, display and merchandising solutions for over 1,800 brands, both in-store and online. Our ORBIS business believes there is a better way to optimize today's supply chains, with reusable packaging products and services. Reusable containers, pallets, dunnage, bulk systems and metal racks improve the flow product all along the supply chain to reduce costs, enhance profitability and add sustainability. Our products and services are used by global, name-brand companies in the food, beverage, health and beauty, over-the-counter pharmaceutical, industrial, automotive, and electronics industries. Come build an exciting, rewarding career with us, where you'll have opportunities to grow. The possibilities are endless. The power is yours! Menasha Corporation and its subsidiaries and affiliates are equal opportunity employers. All qualified applicants will be provided with equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or genetic information.

Job Title: QA Coordinator, Inventory FLSA Status: Non-Exempt Key Responsibilities Product Substitution & Allocation Review production and warehouse inventory daily to identify substitution opportunities that maintain quality and reduce relabeling needs. Allocate product for outbound loads based on lot codes in BatchMaster, ensuring QA and customer specifications are met. Collaborate with Production Planning and Warehouse personnel to substitute or reassign lots proactively during production. Ensure all substitutions are properly documented in BatchMaster and physically reflected on product labeling. Responsible for allocating appropriate rework materials for specific production runs, ensuring compatibility with product formulation, lot control, and QA approval. Relabeling & Placard Management Coordinate with warehouse staff to re-label products with updated lot or substitution information. Reprint, verify, and validate new placards ensuring accurate product descriptions, lot codes, expiration dates, and quantities. Maintain complete records of relabeling and substitution activities for QA traceability. Inventory & Cycle Counting Conduct cycle counts of substituted products, partial pallets, and QA-hold inventory. Investigate and reconcile discrepancies between BatchMaster ERP and physical stock. Assist Warehouse and QA leadership in corrective actions related to count variances. Participate in scheduled Warehouse Inventory Audits. Auditing & Quality Verification Audit finished product received at the warehouse from production for label, lot, and quality compliance. Verify substituted or relabeled products meets QA release and customer requirements prior to shipment. Support warehouse quality inspections and maintain documentation for audits (internal, SQF, FSSC, or customer). Continuous Improvement Identify patterns of relabeling, substitution, or inventory errors and recommend process improvements. Work with QA and Warehouse Managers to streamline product flow, traceability, and ERP transaction accuracy. Qualifications Associate's or bachelor's degree in quality, Supply Chain, or related field preferred. Equivalent work experience in lieu of degree will also be considered. 2-3 years of experience in food manufacturing, inventory control, or ERP systems. Familiarity with BatchMaster ERP (or other ERP systems) preferred. Strong understanding of lot traceability, labeling requirements, and food safety principles. Excellent organizational, communication, and documentation skills. Ability to work collaboratively across Quality and Warehouse functions. Physical & Work Environment Strong Microsoft Suit skills are preferred. Work performed in both office and warehouse settings. 50/50 split. Must be able to stand, walk, and lift up to 40 lbs on occasion.

Will work with SMT or electronic assembly process. Will work with groups in Production and Japan to help solve quality problems occurring in process. This could involve PPAP's, containment, issuing corrective actions and provide follow-up/solutions as well as writing detailed reports on analysis, help with work instructions, deal with component issues. Will be involved with troubleshooting control units to understand where defect is coming from so knowledge of electrical/electronics is needed. Responsible for cost reductions for defects. Will use 8D/5 Why problem solving to identify root cause and establish counter-measures and improve processes. Skills quality, problem solving, Corrective Actions, electronics, Root cause analysis, oscilloscope, Ppap, circuit analysis, customer service, circuit testing Top Skills Details quality,problem solving,Corrective Actions Additional Skills & Qualifications Bachelors in Engineering (Electrical preferred) oscilloscope experience/knowledge Ability to read and understand electrical schematics and mechanical blueprints strong troubleshooting excellent customer service skills (written and verbal communication) Preferred - experience in automotive quality Honda, Nissan, or other OEM auto quality experience Possess a general working knowledge of automotive or industrial manufacturing (AIAG, PPAP, PFMEA, Control Plan, 8D). Experience Level Entry Level Job Type & Location This is a Contract to Hire position based out of Harrodsburg, KY. Pay and Benefits The pay range for this position is $63.50 - $75.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Harrodsburg,KY. Application Deadline This position is anticipated to close on Jan 31, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

This role is responsible for ensuring the quality of purchased materials and products by strengthening supplier controls, managing incoming quality processes, and driving continuous improvement across the supply base. Core Accountability Areas Manage supplier-related quality issues, including complaints, corrective actions, and containment activities. Maintain and update supplier quality documentation, certifications, and scorecards. Coordinate with suppliers on material sorting, returns, and corrective action plans. Oversee incoming inspection processes and ensure compliance with established procedures. Conduct supplier audits (remote and onsite) and support supplier development initiatives. Support supplier product releases, PPAP approvals, and change management (4M). Monitor supplier and process KPIs using SPC and other quality tools. Ensure purchased products meet applicable quality, environmental, and customer standards. Compliance & Quality Systems Apply AIAG Core Tools (APQP, PPAP, PFMEA, Control Plan, MSA, SPC). Ensure adherence to IATF 16949, ISO 14001, and customer-specific requirements. Support internal audits and risk management activities. Leadership & Authority Authority to stop production or material release due to quality concerns. Supervise and train incoming inspection personnel. Manage hold areas for nonconforming purchased materials. Background & Qualifications Bachelor's degree in Engineering or related field. Minimum 2 years of manufacturing experience; supplier quality experience required. Experience in supplier quality assurance within an automotive or regulated environment is preferred. Knowledge of GD&T and technical drawing interpretation. Strong analytical, organizational, and communication skills. Technical Skills Proficiency in Microsoft Office 365. ERP system experience preferred.

Precision Resource is a leading global supplier of precision metal components and assemblies using fineblank technology. Our eight North American divisions serve a global customer base with a commitment to continuous improvement. For over 50 years we have provided solutions to quality, cost and production challenges for market-leading customers in the automotive, heavy duty and off-highway vehicles, tools and hardware, electronics and cutlery. Job Description Responsibilities Include Quality system audits and maintenance of ISO/TS 16949 quality systems Process auditing and data analysis for continual improvement Capability and measuring systems analysis and corrective action activities Auditing and tracking of suppliers Position reports directly to Quality Manager and assists in training of quality and production team members Qualifications 5 years quality experience in an automotive metal stamping/metal fabrication environment 4 year degrees in applied sciences Working knowledge of SPC, blue print reading, measuring tools and measuring system analysis Hands on experience in Kaizen/Six Sigma continual improvement applications Development or maintenance of ISO/TS 16949 quality system Employment history must show progressive advancement responsibilities in the quality field CQE, CQA, Six Sigma certification will be a plus Additional Information

The Senior Manager, Centers of Excellence (CoEs) is responsible for establishing, leading, and optimizing one or more prioritized CoEs within the Global Quality Operations organization-such as Inspection Readiness, Audit Effectiveness, or other strategic focus areas. This role drives execution of CoE initiatives, develops tools and frameworks, and delivers performance metrics and dashboards to support continuous improvement and operational excellence. The ideal candidate will have strong global collaboration skills and experience working across cross-functional teams in a matrixed environment. **Key Responsibilities** **Centers of Excellence Leadership** + Lead the development and execution of one or more CoEs (e.g., Inspection Readiness, Audit Effectiveness) aligned with global quality priorities. + Establish CoE charters, operating models, and governance structures to ensure clarity and accountability. + Develop and maintain tools, templates, and guidance documents to support CoE objectives. + Collaborate with global and regional quality teams to ensure consistent implementation and adoption of CoE practices. **Execution & Delivery** + Drive the day-to-day operations of assigned CoEs, ensuring timely delivery of initiatives and measurable outcomes. + Coordinate cross-functional working groups and facilitate workshops to gather input and share best practices. + Support the development and rollout of training and communication materials related to CoE initiatives. **Metrics & Performance Tracking** + Define and track key performance indicators (KPIs) to measure CoE impact and effectiveness. + Develop dashboards and reporting tools to provide visibility to leadership and stakeholders. + Analyze data to identify trends, gaps, and opportunities for improvement. **Global Collaboration & Stakeholder Engagement** + Partner with stakeholders across Regulatory Affairs, Clinical, Manufacturing, Compliance, and IT to align CoE efforts with broader quality strategies. + Serve as a point of contact for CoE-related inquiries and support global engagement and alignment. + Contribute to enterprise-wide business excellence initiatives as needed. **Team & Project Support** + May supervise or mentor junior staff or contractors supporting CoE activities. + Provide project management support for CoE-related initiatives. + Promote a culture of collaboration, accountability, and continuous improvement. **Qualifications** Required + Bachelor's degree in life sciences, engineering, business, or related field. + 5-7 years of experience in pharmaceutical quality, operations, or business excellence roles. + Solid understanding of GxP principles and global regulatory expectations. + Experience supporting audit or inspection readiness programs. + Strong communication and collaboration skills across global teams. + Proficiency in MS Office and data visualization tools (e.g., Excel, Power BI, Tableau). Preferred + Experience establishing or managing Centers of Excellence or similar operational frameworks. + Lean Six Sigma or similar continuous improvement certification. + Familiarity with quality management systems and digital tools. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Job Title: Quality EngineerJob Description We are seeking an Advanced Quality Engineer who will play a pivotal role in the launch of new programs. This position involves creating documentation for Production Part Approval Processes (PPAPs), which may include utilizing tools such as Process Failure Mode Effects Analysis (PFMEA) and process flow diagrams. The engineer will also work to develop quality systems for upcoming production programs. Responsibilities + Participate as a key member of the core launch team from product kickoff through the entire life cycle of the parts, responsible for all advance quality elements as defined in RASIC and CLC procedures. + Assist in developing and training all operational groups on processes and requirements related to the launch of new programs. + Understand, communicate, and train all operational personnel on customer-specific requirements. + Lead and participate in corrective action audits and problem-solving teams to support Continuous Improvement to meet performance criteria once a new program is launched. + Perform Process Capabilities and Measurement studies using statistical techniques as necessary to support new program launch and Geometric Dimensioning and Tolerancing (GD&T) requirements. + Develop, document, and provide continuous improvement in manufacturing processes to support quality, cost, and customer expectations. + Act as a liaison with external parties (customers and suppliers) on matters relating to new program requirements. + Develop gauges and gauge instructions with input from the customer and train quality team members on the correct use of gauges. + Coordinate the collection of all data required for customer PPAP approval in a timely manner and prepare paperwork to obtain customer approval for the PPAP packages for assigned programs. + Obtain required customer signoffs for boundary samples, appearance approvals, and fit/function approvals. + Ensure adequate delineation of quality requirements to suppliers through the Purchasing department. + Designate the quality characteristics to be measured and methods/processes for performing quality evaluations, including PPAP submissions, inspection, and test equipment. + Read and interpret GD&T, direct dimensional layout, and test timing as needed to meet PPAP submission date. + Participate in any warranty analysis and investigation. Essential Skills + Experience with PPAP, PFMEA, and quality engineering. + Proficiency in root cause analysis and quality auditing. + Knowledge of quality management and quality management systems. + 1+ years of experience in manufacturing quality engineering. Additional Skills & Qualifications + Associates or Bachelors degree. + Preferred experience in automotive manufacturing. + Experience with injection mold, plating, and assembly. Work Environment The work environment includes injection molding and plating lines, which can be hot and dirty in some areas. The site requires a self-starter with high initiative due to limited technical support on-site. The position offers six paid holidays and one week of PTO. It is a fast-paced environment with opportunities to help build the Engineering team following recent management changes. Job Type & Location This is a Contract to Hire position based out of Nicholasville, KY. Pay and Benefits The pay range for this position is $35.00 - $47.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Nicholasville,KY. Application Deadline This position is anticipated to close on Jan 29, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

Job DescriptionSupplier Quality Engineer This role is responsible for ensuring the quality of purchased materials and products by strengthening supplier controls, managing incoming quality processes, and driving continuous improvement across the supply base. Core Accountability Areas Manage supplier-related quality issues, including complaints, corrective actions, and containment activities. Maintain and update supplier quality documentation, certifications, and scorecards. Coordinate with suppliers on material sorting, returns, and corrective action plans. Oversee incoming inspection processes and ensure compliance with established procedures. Conduct supplier audits (remote and onsite) and support supplier development initiatives. Support supplier product releases, PPAP approvals, and change management (4M). Monitor supplier and process KPIs using SPC and other quality tools. Ensure purchased products meet applicable quality, environmental, and customer standards. Compliance & Quality Systems Apply AIAG Core Tools (APQP, PPAP, PFMEA, Control Plan, MSA, SPC). Ensure adherence to IATF 16949, ISO 14001, and customer-specific requirements. Support internal audits and risk management activities. Leadership & Authority Authority to stop production or material release due to quality concerns. Supervise and train incoming inspection personnel. Manage hold areas for nonconforming purchased materials. Background & Qualifications Bachelor's degree in Engineering or related field. Minimum 2 years of manufacturing experience; supplier quality experience required. Experience in supplier quality assurance within an automotive or regulated environment is preferred. Knowledge of GD&T and technical drawing interpretation. Strong analytical, organizational, and communication skills. Technical Skills Proficiency in Microsoft Office 365. ERP system experience preferred.

Precision Resource is a leading global supplier of precision metal components and assemblies using fineblank technology. Our eight North American divisions serve a global customer base with a commitment to continuous improvement. For over 50 years we have provided solutions to quality, cost and production challenges for market-leading customers in the automotive, heavy duty and off-highway vehicles, tools and hardware, electronics and cutlery. Job Description Responsibilities Include Quality system audits and maintenance of ISO/TS 16949 quality systems Process auditing and data analysis for continual improvement Capability and measuring systems analysis and corrective action activities Auditing and tracking of suppliers Position reports directly to Quality Manager and assists in training of quality and production team members Qualifications 5 years quality experience in an automotive metal stamping/metal fabrication environment 4 year degrees in applied sciences Working knowledge of SPC, blue print reading, measuring tools and measuring system analysis Hands on experience in Kaizen/Six Sigma continual improvement applications Development or maintenance of ISO/TS 16949 quality system Employment history must show progressive advancement responsibilities in the quality field CQE, CQA, Six Sigma certification will be a plus Additional Information

The Senior Manager of Global Quality Management (GQM) supports the execution of clinical quality activities to ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and internal standards across global clinical trials. This role provides hands-on quality oversight, supports audit and inspection readiness, and collaborates with internal teams and external partners to maintain high-quality standards throughout the clinical development lifecycle. **Key Responsibilities** **Clinical Study Support** + Serve as a GCP quality resource to clinical teams during study planning, conduct, and close-out. + Support the review of study documents (e.g., protocols, monitoring plans, vendor agreements) for quality and compliance. + Assist in identifying and resolving quality issues, protocol deviations, and potential noncompliance. + Collaborate with Clinical Operations, Regulatory Affairs, and Medical Affairs to embed quality practices throughout the study lifecycle. **Inspection Readiness** + Support inspection readiness activities including mock audits, documentation reviews, and training coordination. + Maintain inspection readiness tools, trackers, and communication plans. + Participate in regulatory inspections and assist in preparing response documentation. **Audit Program Execution** + Contribute to the development of the annual audit plan using risk-based approaches. + Coordinate and support investigator site, vendor, and internal process audits. + Track audit findings and ensure timely implementation of corrective and preventive actions (CAPAs). + Monitor audit trends and escalate recurring issues to senior leadership. **Quality Systems & Compliance** + Support the implementation and continuous improvement of clinical quality systems, SOPs, and policies. + Assist with deviation management, root cause analysis, and CAPA tracking related to clinical activities. + Stay current with evolving global GCP regulations and industry best practices. **Collaboration & Team Support** + Partner with internal stakeholders and CROs to ensure consistent quality oversight. + May mentor junior staff or contractors. + Contribute to cross-functional initiatives that promote a culture of quality and compliance. **Qualifications** Required + Bachelor's degree in life sciences or related field; advanced degree a plus. + 6-8 years of experience in clinical quality assurance or clinical research within the pharmaceutical or biotech industry. + Solid understanding of GCP, ICH guidelines, and global regulatory requirements. + Experience supporting inspection readiness and participating in audits or inspections. + Strong communication, organizational, and problem-solving skills. + Ability to travel domestically and internationally as needed. + Proficiency in MS Office (Word, Excel, PowerPoint). **Preferred:** + Experience with TrackWise or similar quality management systems. + Prior collaboration with CROs and external vendors. + Exposure to FDA or other health authority inspections. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.