Quality assurance manager jobs in Anderson, IN - 251 jobs

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network. The purpose of this position is to provide oversight and drive / maintain harmonization of technical programs that govern implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Network. This position also influences peers within Lilly globally and at the site level, as well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and enables building technical capability at Lilly sites to ensure the vital capabilities are developed and in place to meet business objectives. Finally, this role provides ad-hoc technical support to Lilly PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. Responsibilities: Assess differences in current sterility assurance programs across the sites and drive harmonization Work closely with site and multi-functional SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. Assume SME leadership role for a specific topic area within Sterility Assurance across the network, including harmonization of aspects of the topic area and facilitation of the knowledge across the network. Represent TS/MS on network Science Lead Team and other appropriate governance forums. Ensure that Sterility Assurance programs and similar topics are frequently presented to network team in order to align across sites. Ensure that learnings and best practices are shared across sites: set-up appropriate forums in order to achieve this and present case studies to site SMEs. Provide mentoring leadership to site SMEs to help build continue to build capability, particularly at the newer sites or where deep technical expertise is lacking. Building, maintaining, and growing capability across the organization in the sterility assurance space Provide technical support to new sites/ filling lines during design and start-up activities to ensure sterility assurance programs and process/ product requirements are supported at these sites, particularly while the sites are in early stages of building capability. Provide technical support for significant sterility assurance investigations to help identify root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across the other sites. Benchmark industry trends and emerging regulatory guidance / requirements in the field through building an extensive peer network and attendance at relevant industry and regulatory meetings and advocacy groups. Advance Lilly agenda in the field. Represent Lilly on relevant external bodies related to Sterility Assurance; be influential in terms of representing Lilly's position on technical/ regulatory positions papers and guidance. Assess new technologies to ensure Lilly stays current with new trends and technologies and share with the network with the goal of staying current with industry best practice. Work with PR&D on new technology / platform development and implementation for pipeline products. Influence the agenda within PR&D to ensure the needs of Manufacturing are met, and the control strategies are fit for-purpose for robust and compliant commercial manufacturing. Provide ad-hoc technical support to Lilly organizations outside of the PPN including PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. Engage in providing support during regulatory interactions such as RtQ of submissions, and on-site inspections Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals Basic Qualifications: BS Degree required. MS/PhD in a biological science preferred. 10+ years' experience working in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles preferred. 10+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment preferred. Deep technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, Annex 1 interpretation) Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities Strong written and oral communication skills Ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance Demonstrated experience influencing site and network leaders to advance technical agenda projects Additional Preferences: Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed. Support the establishment of a sterility assurance network or hub in global TSMS Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance Experience in leading external committees or conferences to ensure Lilly remains a leader in the sterility assurance space Work with engineering SME's to support Lilly platforms to maximize the performance and minimize the risk of sterility assurance Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options. Strong capability to influence personnel and management across the organization Close interaction with quality to enable internal audits that identify risks Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance. Additional Information: Approximately 25% travel Lilly currently anticipates that the base salary for this position could range from between $133,500 to $220,000 and will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $133,500 - $246,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Job Description Journey is growing, and we are looking for a passionate Director of Quality Assurance (RN) to support and enhance clinical excellence across our facilities. This leader will play a key role in strengthening our quality outcomes, supporting our facility teams, and ensuring we continue to provide exceptional care to the residents we serve. What You'll Do: Serve as a clinical resource and support partner to our buildings. Lead auditing, quality improvement initiatives, and compliance oversight. Assist with survey readiness, regulatory standards, and follow-up plans. Coach and mentor clinical leadership teams to elevate performance and resident outcomes. Monitor key quality and clinical metrics to guide improvement strategies. Collaborate with senior leadership on best practices and process enhancements. Ensure alignment with Journey's mission, values, and commitment to resident-centered care. What We're Looking For: Registered Nurse (RN) in good standing Strong background in long-term care, skilled nursing, or clinical operations. Knowledge of state and federal regulatory standards. Experience with survey processes and quality assurance/performance improvement (QAPI). Effective communicator with the ability to coach, support, and guide clinical teams. Organized, proactive, and driven to make a meaningful impact. Previous Director of Nursing or MDS experience in long term care. Why Journey: At Journey, we believe in supporting our people so they can support others. We value collaboration, growth, and leadership that lifts others up. You will be joining a team that works with purpose, leads with heart, and is genuinely committed to making a difference every day. If you are a clinical leader who is passionate about improving quality outcomes and empowering teams, we would love to connect.

Title: Global Quality Assurance Manager Worksite Location: Westfield, Indiana Duties: Indiana Mills & Manufacturing Inc. d/b/a IMMI seeks a Global Quality Assurance Manager to coordinate and manage all incoming inspection and testing activities. Assist the appropriate Design Engineering, Product Engineering and Manufacturing Engineering personnel to conduct, develop and document Process and Design FMEA's, utilizing the APQP process. Assist the Supplier Quality Manager and Purchasing teams in supplier development activities and/or testing to validate components. Provide and maintain a state-of-the-art inspection lab to serve IMMI Purchasing, Engineering and manufacturing in the inspection and testing of incoming and outgoing material. Develop and improve the overall inspection and testing process for better effectiveness. Supervise and direct the activities of the Quality Assurance Technician team. Administer the IMMI Quality System within the Quality Assurance Lab to ensure compliance with ISO-9001 or appropriate standards and all customer expectations. Assist with IMMI QMS internal and external auditing activities. Ensure proper housekeeping in the Quality Assurance Lab. Assist in the development of new test fixtures, methods and equipment required by acting as liaison with internal and external engineering teams. Assist in writing summary reports that are worded appropriately, preventing the casting of doubt on IMMI products, development and testing efforts. Provide technical support to Reliability and Compliance, Engineering and Marketing by representing the Quality Assurance group as needed. Assist with customer visits as requested. Support and/or maintain a comprehensive corrective action program using problem solving tools and root cause analysis to identify and address product, process, or testing integrity or reliability issues. Ensure the confidentiality of sensitive information with internal or external customers. Insure and maintain data integrity of all testing results. All other duties as assigned by the Vice President of Quality Assurance. Up to 10% to customers, suppliers, and/or other IMMI plants when needed. The geographic areas for such travel include: IMMI plants located in Georgia, North Carolina, Illinois, and Kansas, and IMMI's customers and suppliers located in Oklahoma, Texas, Wisconsin, Washington, and Ohio. Requirements: Bachelor's Degree in industrial engineering, mechanical engineering, electromechanical engineering, or related field. 2 years of experience with the test and validation of new product designs and conformance of production testing for seat belts, air bags, seats, steering wheels as it relates to FMVSS, ECE, or customer specific testing including development and maintenance of appropriate fixtures to hold part in test position appropriately and review and approval of test reports. 2 years of experience in managing production floor quality as it pertains to safety and quality fit, form, and function including fast response for quality issues. 2 years of experience in the corrective action process for internal or external (customer) concerns when raised by using the appropriate investigative tools and report to the appropriate representative (internal manger/VP or customer). 2 years of experience in Quality Management System and overseeing compliance to international standards, including but not limited to IATF, BAM, ISO, and VCA. 2 years of experience in the cross functional collaboration with Engineering and Quality in the Design Review process for development of new products. This includes application of past problem history and/or testing for part performance. 2 years of experience in execution of APQP (Advance Quality Planning) for the launch of new products and change point of existing product. 2 years of experience in the warranty and field return investigations including trend analysis, field return tracking, and corrective action report for such claims. 2 years of experience in the warranty and field activities for product performance. Knowledge in FMVSS, ECE, and development testing of Seat Belts, Air Bags, Steering Wheels, and other safety products. To apply: Interested candidates should visit *************************************** UI/CandidateExperience/en/sites/CX_1/ and search by keyword “Global Quality Assurance Manager” and Location (Westfield, Indiana, United States). LR11655.0***********-8579-7244v2

We Are: Are you ready to step into the heart of digital transformation in one of the world's most critical - and most dynamic - industries? The Chemicals Industry is evolving at lightspeed: demand for sustainability-driven products is on the rise. At the same time, digital platforms, real-time analytics, AI, and SAP-enabled processes are no longer "nice to have" - they are foundational. As part of Accenture's SAP Chemical's Practice, you'll be delivering major SAP engagements (for example, Business Transformation Strategy & Roadmaps, migrations to SAP S/4HANA, process standardization, cloud-enablement) that help clients win in this new environment and guide major Chemical clients through the journey of business-model reinvention, process excellence and enterprise technology enablement You Are: Do you have a passion for storytelling and for originating, selling and delivering SAP-based Supply Chain Transformation projects that make a positive impact in your clients' business? Are you inspired by working with the best companies in their industries? Want a role that provides you with a sense of purpose and satisfaction? Then join Accenture and build a rewarding career improving the way the world works and lives, as you help clients innovate with leading-edge SAP and Accenture Supply Chain solutions and technologies on some of the most innovative projects in the world You will thrive in our highly collaborative, digitally-driven and innovation-led environment while nurturing your talent for thoughtful and game changing solutions in our inclusive culture that values diversity of ideas, experiences and backgrounds. Ultimately, you are a confident manager who spots and stays ahead of the SAP platform, industry and Supply Chain trends and knows how to translate client goals into clear and actionable outcomes that everyone can get behind. You know how to fully utilize the capabilities of various SAP platforms to drive business value, transform end-to-end functions and drive leading practices for your clients in markets all over the globe. The more complex their challenges, the more excited you are about leading the charge to solve them. The Work: Team with clients on their SAP functional transformation programs through your combined SAP application and functional process expertise which includes your ability to: + Engage with client executives on the business challenges/trends and the potential value of SAP solutions (current & future) + Lead customers in defining their SAP journey through the development of business cases & roadmaps including during sales origination, proposal development and client presentations + Architect E2E solutions that leverage SAP technologies, custom apps, & add on partner solutions + Advise, design and deliver solutions based on the latest industry and technology best practices leveraging a SAP solutions and embedded innovation. + Lead small teams - helping them achieve transformational roadmaps - onsite with clients or within Accenture + Become a trusted expert and advisor to your clients, team, and Accenture Leadership by staying current on regulations, trends, and innovations across your area of expertise + Be a thought leader, build assets and best practices and develop the next level of transformation experts Travel may be required for this role. The amount of travel will vary from 0 to 100% depending on business need and client requirements Here's what you need: + Minimum of 5 years of SAP functional and technical experience/expertise in Quality Management and/or Manufacturing. + Minimum 3 years of experience in SAP projects supporting Chemicals clients. (SAP support / managed services experience will not be considered for this requirement) + Minimum 2 end-to-end SAP S/4 implementations, including project planning, estimation and solution architecture for Chemicals clients + Experience managing SAP delivery teams, in a Global Delivery Model, including but not limited to the following responsibilities: driving complex workshops and leading design decisions, as well as leading the design and execution of system build, configuration, testing, cutover, and go-live in the SAP Transportation Management or Quality Management area + Prior experience in a Consulting and/or Advisory role + Bachelor's degree or equivalent (minimum 12 years' work experience). If Associate's Degree, must have equivalent minimum 6-year work experience Compensation at Accenture varies depending on a wide array of factors, which may include but are not limited to the specific office location, role, skill set, and level of experience. As required by local law, Accenture provides a reasonable range of compensation for roles that may be hired as set forth below.We anticipate this job posting will be posted on 01/24/2026 and open for at least 3 days. Accenture offers a market competitive suite of benefits including medical, dental, vision, life, and long-term disability coverage, a 401(k) plan, bonus opportunities, paid holidays, and paid time off. See more information on our benefits here: U.S. Employee Benefits | Accenture (******************************************************* Role Location Annual Salary Range California $94,400 to $293,800 Cleveland $87,400 to $235,000 Colorado $94,400 to $253,800 District of Columbia $100,500 to $270,300 Illinois $87,400 to $253,800 Maryland $94,400 to $253,800 Massachusetts $94,400 to $270,300 Minnesota $94,400 to $253,800 New York $87,400 to $293,800 New Jersey $100,500 to $293,800 Washington $100,500 to $270,300 Requesting an Accommodation Accenture is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Accenture and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired. If you would like to be considered for employment opportunities with Accenture and have accommodation needs such as for a disability or religious observance, please call us toll free at **************** or send us an email or speak with your recruiter. Equal Employment Opportunity Statement We believe that no one should be discriminated against because of their differences. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. For details, view a copy of the Accenture Equal Opportunity Statement (******************************************************************************************************************************************** Accenture is an EEO and Affirmative Action Employer of Veterans/Individuals with Disabilities. Accenture is committed to providing veteran employment opportunities to our service men and women. Other Employment Statements Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States. Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration. Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process. Further, at Accenture a criminal conviction history is not an absolute bar to employment. The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. Additionally, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the Company's legal duty to furnish information. California requires additional notifications for applicants and employees. If you are a California resident, live in or plan to work from Los Angeles County upon being hired for this position, please click here for additional important information. Please read Accenture's Recruiting and Hiring Statement for more information on how we process your data during the Recruiting and Hiring process.

The Director, Quality & Compliance Training, is a senior leader within the Learning Center of Excellence under Global Quality. This role is responsible for developing and executing global training strategies for various functions (e.g., Commercial, Finance, HR, Legal, and other General & Administrative areas). The position ensures that learning programs drive business performance, compliance with corporate standards, and foster a culture of continuous development across the organization. **Key Responsibilities:** **Strategic Leadership & Governance** + Define and lead the global training strategy aligned with corporate objectives and quality principles. + Establish governance frameworks for training compliance and operational excellence, including policies and SOPs. + Serve as a key advisor to senior leadership on learning trends, capability-building strategies, and risk mitigation. **Program Development & Delivery** + Design and oversee training programs for Commercial and G&A functions, ensuring relevance and scalability. + Implement innovative learning solutions leveraging adult learning principles, digital platforms, and blended learning approaches. + Ensure training content aligns with corporate standards and supports organizational priorities. **Stakeholder Engagement & Collaboration** + Partner with functional leaders, HR, and Quality to identify learning needs and align initiatives with business goals. + Act as a trusted advisor to senior leadership on training effectiveness and workforce capability development. **Continuous Improvement & Analytics** + Define KPIs and leverage data analytics to measure training impact and drive enhancements. + Stay current with industry best practices, emerging technologies, and evolving business needs to continuously improve learning programs. **Operational Oversight** + Collaborate with training operations teams to ensure efficient delivery and compliance tracking. + Oversee vendor relationships for training services and technology solutions **Qualifications:** + Bachelor's degree required; advanced degree in Life Sciences, Education, Organizational Development, or related field preferred. + 10+ years in pharmaceutical or life sciences industry with significant experience designing and implementing global training programs. + Proven track record in designing and implementing global training programs and managing cross-functional teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA, EMA, etc.). + Proven ability to design and deliver impactful learning programs using adult learning principles. + Experience with learning technologies (e.g., LMS, virtual learning platforms) and data-driven training strategies. + Excellent communication, collaboration, and stakeholder engagement skills. **Preferred Attributes:** + Strategic thinker with a passion for scientific learning and development. + Agile and adaptable in a fast-paced, matrixed environment. + Strong project management and organizational skills. + Committed to fostering innovation, compliance, and continuous improvement through learning. **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 $164,530.00 - Maximum $245,985.00, 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.

QA Director Job Responsibilities: Assures quality products and processes by establishing and enforcing quality standards and testing materials and products. Establishes quality and reliability standards by studying product and consumer requirements with other members of management and with production operators, technicians, and engineers. Develops raw material standards by studying manufacturing and engineering requirements, conferring and negotiating with suppliers, and devising testing methods and procedures. Implements in-process product inspection standards by studying manufacturing methods and devising testing methods and procedures. Establishes standards for the disposition of finished product by devising evaluation tests, methods, and procedures. Institutes rework standards by devising inspection and physical testing methods and procedures. Creates product quality documentation system by writing and updating quality assurance procedures. Maintains product quality by enforcing quality assurance policies and procedures and government requirements. Collaborates with other members of management to develop new product and engineering designs and manufacturing and training methods. Prepares product and process quality reports by collecting, analyzing, and summarizing information and trends. Completes quality assurance operational requirements by scheduling and assigning employees and following up on work results. Develops a quality assurance staff by recruiting, selecting, orienting, and training employees. Manages quality assurance staff job results by coaching, counseling, and disciplining employees. Ensures quality by planning, monitoring, and appraising job results. Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies. Achieves financial objectives by preparing the quality assurance budget, scheduling expenditures, analyzing variances, and initiating corrective actions. Contributes to team effort by accomplishing related results as needed. QA Director Qualifications/Skills: Leadership Strong written and verbal communication skills Analytic skills Collaboration skills Product management skills QA process skills Computer knowledge and skills

Pepper Construction is building a culture of quality where project teams and trade partners take ownership of the work and build it right the first time. Our Quality Department team members provide industry-leading expertise and advice in Building Enclosure and MEP Systems, lead the quality process and are a valuable resource to our project teams. Our company vision is to deliver the ultimate experience to our clients, trade partners, and each other while being leaders in our industry and community. Our Quality team plays a big part in achieving this vision. A typical week for a Quality Manager may include the following: Running preinstallation meetings with our trade partners Walking a jobsite to evaluate construction work in-place Writing quality observation reports following a site visit Performing a constructability review for a future project Developing a job specific quality plan with a project team The Quality Manager is always on the go and generally sets their own schedule, typically managing the quality process for several projects at a time. Our quality team members attend 4-5 national conferences or training events every year to develop their knowledge and maintain their credentials. Pepper's Quality Department leads quarterly internal training for our project managers and superintendents to keep our quality culture fresh and present the details of a technical topic. The ideal Quality Manager is a sharp, curious, problem-solver and an excellent communicator. They are interested in the details of construction and seek to understand the best way to put things together. The Quality Engineer serves as a resource to the project team in the areas of project delivery, constructability, workflow and sequencing, and proper installation techniques. MAJOR RESPONSIBILITIES: Assist Project Teams: Leads Project Teams in developing the Job Specific Quality Plan. Reviews Construction Documents, Specifications, Shop Drawings, and Submittals with the intent to identify challenges and opportunities. Assist Trade Partners: Leads project Quality pre-installation meetings with Trade Partners. Works with subcontractors to develop and implement Trade Partner Job Specific Quality Plans. Conduct Quality Site Visits: Reviews and documents work in the field. Photographs and discusses work in place with the project team. Writes reports for each site visit, providing directions and suggestions to correct improper work-in-place. Assist in Preconstruction: Conducts constructability reviews of future jobs to identify risks and incorporate lessons learned and best practices before construction starts. Education & Growth: Participates in education and growth opportunities to remain relevant and aware of current trends affecting construction and quality. Attend industry events in the local area and out of town events four to five times a year. Past conferences have included organizations such as Air Barrier Association of America (ABAA), International Institute of Building Enclosure Consultants (IIBEC), World of Concrete, American Contractors Insurance Group (ACIG), Construction Specifiers Institute (CSI), Building Enclosure Science and Technology (BEST), and more. Expertise: The Quality Engineer will have a general understanding of all elements of construction but will develop focused expertise in building enclosure, concrete, metal stud framing and drywall, flooring, and life safety systems. POSITION REQUIREMENTS: Education: Bachelor's degree in Construction Management, Engineering, Architecture, or related field. Experience: 3+ years' experience in Construction Management, Design, Construction Technology, or Construction Testing. Strong background and understanding of Construction Documents and Submittals. A general understanding of the construction process and how buildings go together is required. Knowledge of or experience with building enclosures, concrete, drywall framing, life safety, and flooring are a plus. Certifications: Building Enclosure Certifications such as Registered Roof Observer (RRO), Registered Exterior Wall Observer (REWO), Certified Air Barrier Specialist (CABS) are a plus. Concrete certifications from ACI are a plus. Attributes: Excellent problem-solving skills with a strong curiosity for how systems operate together. Always maintains a calm demeanor. Able to explain things clearly both verbally and in writing. Self-motivated and able to work independently or as part of a team. Travel: Able to travel throughout Central Indiana but will typically be home every night. Pepper will provide a company vehicle or stipend for local travel. Overnight travel is required 4-5 times per year for conferences. Physical Requirements: Must be able to visit and work within an active multi-level construction site, including the use of ladders, scaffolds, and lifts. Must be able to stand and walk for long periods of time when necessary. Must be able to wear personal protective equipment for several hours per day. Schedule: Daily work schedule is typically between 8AM - 5PM. Applicants whose background is exclusively in manufacturing will not meet the requirements for this role.

Scismic is supporting a global consulting company that fosters a highly collaborative and inclusive culture, encouraging creativity, growth, and innovation. With a team of over 1,000 professionals across 50 global markets, the organization partners with world-class clients to solve complex business challenges across diverse industries. The company values a “builder's mindset,” empowering employees to create new solutions, develop lasting impact, and grow their careers in a supportive environment. QA Manager - you will manage a team of 62 people (36 in QA and 26 in Sanitation). This is a hands-on, boots on the ground role. You will ensure quality in the factory and are responsible for meeting quality targets. You are fully responsible for the people, machinery and the identification and elimination of quality losses and problems in the department. You grow your team's capabilities and coordinates departmental activities in accordance with corporate standards, local requirements and ISO standards. In this role, you report directly to the plant manager with dotted line responsibility to corporate quality. How you will Contribute:You will ensure that all quality objectives, goals and targets in the factory (including regional and global commitments) are met. You will develop and track your department's budget and eliminate losses. With your team, you will conduct regular plan-do-act-check assessments to plan how targets will be met, executing the plan and periodically checking and taking action to stay on track. In addition, you will ensure that there is strict adherence with all appropriate laws, food safety quality standards and consumer requirements of all manufactured products and manage crisis situations internally and externally in ways that support the company's image, policies and business. As a people leader, you are responsible for recruitment and structuring of the department to ensure there are sufficient resources to deliver on plant objectives, set and assess performance goals, and coach and mentor team members. Requirements:Minimum 7+ years of Quality experience in food / pharma industry.Minimum of 5 years of demonstrated leadership position in a Manufacturing PlantEducation: BS Food Science or related required Proven leadership experience required Growth mindset Experience with sanitation is required Experience with compliance systems, food defense systems, audit and budgeting Experience with GFSI - FSSC, Organic, Kosher, and Rainforest Alliance implementation and compliance is required. Salary - $128-135k, 14% bonus, relocation available to Indianapolis area.

At Indianapolis Fruit Company, our distribution network and premium supply chain provide our team the necessary tools to deliver a full-service retail experience for our customers that will differentiate them from competition and provide great opportunities for success. Indy Fruit team members thrive in our dynamic and collaborative environment in this fast-paced and ever-changing industry. Indy Fruit recognizes the importance of being able to provide our team members and their families with quality benefits as part of their overall compensation package. We provide a comprehensive and competitive package that delivers quality and value while satisfying the diverse needs of our workforce. Since 1947, Indy Fruit has been delivering fresh fruits and vegetables to our valued retail partners throughout the Midwest. We look forward to adding you to our team and continuing our company growth. Essential Functions: Ensure a clean and sanitary operational room for the processing of fruit and vegetables in accordance with company and government standards Ensures a clean and sanitary processing environment for fresh cut fruit and vegetables in accordance with company and government standards (this includes but is not limited to employee practices and sanitation) Maintain and improve environmental monitoring program Lead and participate in product development, including sensory evaluations, shelf life testing and product formulations Ensures that product in the containers match the label on the container, date codes and outgoing packaging/Barcode is correct Ensures processing room is ready for production thirty minutes prior to beginning of day Chemicals were added to the main flume system and Barrels containing chilled water with Peracetic Acid placement, potato line, Apple line and fruit tanks and findings documented Metal detection machines validated at start of shift and throughout production and findings documented Hand and knife dip stations filled with sanitizer with verification of chemical strength is documented Ensure all Products are to be run through metal detection machines at every product change metal detector validation and verification and must be completed and documented Ensure all chemical stations must be checked with every change of product and the check off sheet completed Check Random weight checks, bag leak test, and various other H.A.C.C.P documentation and logs Overall Product Quality, ensuring shelf life and cold chain compliance Purchase supplies as needed such as additives and chemicals used directly in the food processing areas Develop, implement, and maintain a comprehensive food safety and quality program in line with industry standards and regulatory requirements Ensure that all quality assurance processes and procedures are properly documented, regularly reviewed, and continuously improved Participate in internal and external audits to assess the effectiveness of food safety systems and ensure compliance with relevant standards (e.g., SQF, FDA regulations) Lead, mentor, and develop the quality assurance team, fostering a culture of continuous improvement and accountability Conduct regular performance reviews, provide coaching and support, and identify training and development opportunities for team members Work with QA and Food Safety team members across companies to establish best practices Oversee the quality control process for incoming materials, in-process production, and finished products to ensure they meet established quality standards Collaborate with production teams to identify and resolve quality issues, implement corrective and preventive actions and improve product quality Monitor key quality metrics and trends, and report on quality performance to senior management Lead continuous improvement initiatives aimed at enhancing product quality, reducing waste, and improving operational efficiency Facilitate cross-functional teams to drive quality improvement projects Investigate customer complaints, identify root causes, and implement corrective actions to prevent recurrence Ensure timely and effective communication regarding quality issues and resolutions if needed Stay informed of industry regulations and standards and ensure that the company's products and processes comply with all relevant laws and regulations Prepare required documentation and reports and review completed documentation in required time frame Ensure that all employees are trained and aware of the quality standards and regulatory requirements applicable to their roles Coordinate and facilitate training for all production staff Maintain standard operating procedures and overall program compliance Collaborate with production and food safety teams to develop and improve procedures as needed Competencies, Education, and Experience Excellent leadership and team management skills Listening skills Strong problem-solving and analytical skills Organized and attention-to-detail approach Excellent verbal and written communication skills High school diploma or GED equivalent Speak and write English satisfactorily At least 2 years of recent and successful experience performing the above functions in a significant food processing environment and food safety knowledge Strong knowledge of quality management systems (QMS), regulatory requirements, and industry standards Proficient PC skills in Microsoft Office, and common E Mail systems Work Schedule: Tuesday - Saturday Start Time: 5:00am - Finish Physical Demands: Stand or walk for long periods of time Work in cold and wet cooler conditions for extended periods of time Repetitive bending and use of arms, legs etc. Ability to lift 25 lbs Benefits: Health & Welfare Benefits (Medical, Dental, Vision, Disability, and Voluntary Life) Paid Time Off Holidays 401(k) with Company Match Weekly Paid Career Advancement Opportunities All qualified applicants will receive consideration for employment without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state or local laws and ordinances.

Job Title: QA/QC Manager Department: Quality Control The QA/QC Manager both reports to and takes direction from the Senior Director of Operations. The primary responsibility of the QA/QC Manager is to ensure through testing, so all products and services meet client requirements and company standards. The individual must possess a strong background in the Corporate and Company arena. Graywolf Integrated Construction company is a diverse industrial contractor with significant emphasis on ASME Boilers, Pressure Vessels, and Pressure Piping installations and repairs. Candidate must possess a strong background in the ASME B&PV Codes, including but not limited to Sections I, VIII-1, IX B31.1 and B31.3. Candidate must possess a strong background in the development, implementation, and understanding of ASME Welding Procedures (WPS) and Welder Performance Qualifications (WPQ). Candidate must possess a strong background in the NATIONAL BOARD OF Boiler and Pressure Vessel Inspectors (NBBPVI) NBIC Codes for Repairs and Alterations. Performance Objectives: Mentors and coaches' staff; interprets performance and provides feedback. Leads and coordinates the daily activities of the project team. Interprets and applies a strong understand of key indicators to make effective business decisions. Embraces new opportunities and tough challenges with a sense of urgency, and enthusiasm. Secures and deploys resources effectively and efficiently. Cultivates innovation and creates new and better ways for the organization to be successful. Provides direction, delegates, and removes obstacles to get work done with focus on continuous improvement. Develops people to meet both their career goals and organizational goals. Creates a climate where people are motivated to do their best to help the organization achieve it objectives. Gains the trust and confidence of others through honesty, integrity, and authenticity. Rebounds from setbacks and adversity when dealing with difficult situation. Technical Objectives: Manages and oversees corporate and project quality to ensure compliance with Codes, standards & quality program requirements. Promotes Quality Achievement and performance improvement throughout the organization. Manages the development and implementation of the QMS for construction, execution, inspection of documentation, and operations activities including: Planning duties within the QA/QC group to execute QA/QC activities. Establishing standards of service for customers, clients, and departments Identifying & developing workforce planning schedules & quality related training needs Provides functional leadership, mentorship, and direction to all project quality personnel. Develops and implements risk-based inspection activities and processes. Oversees supervision of all visual and NDE inspections including subcontractors. Creates inspection and test plans for new construction, repair work, and alterations. Identifies and plans how to rectify inspection gas issues. Ensures that total quality management principles are integrated in all functions of organization. Promotes, trains, encourages, and otherwise ensures adherence to the QMS as well as applicable Codes and Standards. Ensures all QA/QC requirements are met and are fully in compliance. This includes inspection and testing of “in progress” as well as completed systems and installations. Develops testing plans and manages both defect management and change management processes. Ensures Quality Engineers or others assist with redesign and/or modifications. Plans and manages the activities of departmental staff and provides technical guidance and co-Co-ordination to site personnel. Oversee the continuity and maintenance of the Company's Local, State, or Jurisdictional Certification and Licenses, as well as keeping the Company's ASME and NATIONAL BOARD Certifications and stamps current. Safety Objectives: Managers are responsible for integrating the company's Health and Safety procedures and controls into every activity they manage. All managers are directly accountable for the provisions and maintenance of an effective Safety Program. * Refer to Graywolf Safety Manual for a description of responsibilities. Experience (Required): Above average ability to communicate effectively with all levels of the organization including craft, project management, corporate management, client representatives, and outside regulatory authorities. Must excel at co-ordination, organization, written and verbal communication skills, with strict emphasis on accuracy and attention to detail. Experience working within local jurisdictional authorities and regulatory bodies. Solid understanding of requirements associated with project specific documentation related to turnover, inspection, testing, installations, and quality control including understanding of safety related implementations associated with each process. Supervision of safe storage and verification of all projects related documentation. Experience in project management, including project execution. Education (Required): Certification in architectural, structural, construction or engineering technology or related field with a minimum of 15 + years of experience in heavy construction. American Welding Society (AWS) CWI Certificate Knowledge of Occupational Safety and Health Administration (OSHA) A bachelor's degree in occupational safety is preferred but will consider years of experience in similar role. Graywolf Integrated Construction Company is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, disability, sex, sexual orientation, gender identity or expression, age, national origin, veteran status, genetic information, union status and/or beliefs, or any other characteristic protected by federal, state, or local law. #LI-AC1

Plans, coordinates, and directs the quality control program designed to ensure continuous production of products consistent with established standards. Plays active role on quality management teams within the organization. Designs and implements quality control training programs to key personnel in conjunction with managers. Fulfills supervisory responsibilities in accordance with the organization's policies and applicable laws. Job Duties: Develops and analyzes statistical data and product specifications to determine present standards and establish proposed quality and reliability expectancy of finished product. Formulates and maintains quality control objectives aligned to corporate policies and goals. Creates and implements inspection criteria and procedures. Interprets quality control philosophy to key personnel in the organization. Coordinates objectives with production procedures in cooperation with other plant managers to maximize product reliability and minimize costs. Provides inspection activity for products throughout production cycle. Applies total quality management tools and approaches analytical and reporting processes within each department. Directs workers engaged in inspection and testing activities to ensure continuous control over materials, facilities, and products. Works with vendors to ensure quality of all purchased parts for company use. Other duties as assigned. Job Qualifications: Bachelor's degree in manufacturing management or industrial engineering, Quality Management, or a related field preferred and/or Lean Six Sigma Certification preferred. Five to seven years of experience in a similar role Must have organizational skills with an ability to prioritize and multi-task. Ability to maintain confidentiality, exceptional attention to detail and good follow-up skills. Must have good problem-solving skills. Ability to interact in a professional manner with employees and vendors. Ability to communicate effectively both verbally and in writing. Proficient in Excel and Word Willingness to work as team member or independently. Must be committed to continuous improvement.

Are you looking to take your quality career to the next level? Do you have multi-site manufacturing quality experience in a highly regulated environment with expertise in Quality Control, Quality Assurance, and Lean practices? The successful candidate will lead a plastic flexible packaging quality program across four manufacturing campuses supporting leading food and perishable packaging companies. Key Responsibilities Systems Management: Develop, establish, and maintain global quality systems, programs, policies, processes, procedures, and controls. Ensure the performance and quality of products conform to established standards and agency guidelines to ensure lasting customer satisfaction. Cultural Leadership: Lead a cultural change within the quality organization from reactive to proactive. Establish strong engagement between quality and operations to achieve the company's quality mission. Problem Solving: Implement an effective Root Cause and Permanent Corrective Action process to permanently eliminate quality defects and deliver a significant reduction in customer returns and complaints. Strategy: Develop, implement, and lead an effective quality organizational structure focusing on strategy and driving cultural change within the leadership team. Decision Making: Make final decisions on administrative or operational issues affecting all quality functions. Participate with the leadership team in developing and establishing company-wide policies. Operational Excellence: Maintain accountability for the overall effectiveness and operational success of the global quality organization. Successfully integrate these activities with other major organizational segments. Lead, train, and facilitate a company-wide Continuous Improvement process focused on key company objectives. Requirements Bachelor's degree is required. Quality certifications preferred (e.g., ISO, Six Sigma, Lean). Well-versed in continuous improvement tools and methods with demonstrated proficiency in implementing and facilitating CI teams. Excellent ability to drive and implement Root Cause and Permanent Corrective Action throughout the organization. 5+ years of quality control/quality assurance experience is required, as well as at least 5 years in a global quality leadership role. Demonstrated success in developing and leading a company-wide quality function. Proven success in driving cultural and organizational change that delivers continuous improvement in customer satisfaction. Ability to bring structure and process to an unstructured environment. Previous experience with consumer packaging is strongly desired. Competence in program, metrics, and measures development. Strong people development and cross-functional collaborative skills. Ability to manage horizontally and vertically; ability to articulate strategy and results to the executive team while enabling understanding of quality objectives throughout the organization. Experience with flexible packaging, rigid packaging, and/or printing processes preferred. If you fulfill these responsibilities, please apply. We offer outstanding compensation, including benefits.

Job Description Are you looking to take your quality career to the next level? Do you have multi-site manufacturing quality experience in a highly regulated environment with expertise in Quality Control, Quality Assurance, and Lean practices? The successful candidate will lead a plastic flexible packaging quality program across four manufacturing campuses supporting leading food and perishable packaging companies. Key Responsibilities Systems Management: Develop, establish, and maintain global quality systems, programs, policies, processes, procedures, and controls. Ensure the performance and quality of products conform to established standards and agency guidelines to ensure lasting customer satisfaction. Cultural Leadership: Lead a cultural change within the quality organization from reactive to proactive. Establish strong engagement between quality and operations to achieve the company's quality mission. Problem Solving: Implement an effective Root Cause and Permanent Corrective Action process to permanently eliminate quality defects and deliver a significant reduction in customer returns and complaints. Strategy: Develop, implement, and lead an effective quality organizational structure focusing on strategy and driving cultural change within the leadership team. Decision Making: Make final decisions on administrative or operational issues affecting all quality functions. Participate with the leadership team in developing and establishing company-wide policies. Operational Excellence: Maintain accountability for the overall effectiveness and operational success of the global quality organization. Successfully integrate these activities with other major organizational segments. Lead, train, and facilitate a company-wide Continuous Improvement process focused on key company objectives. Requirements Bachelor's degree is required. Quality certifications preferred (e.g., ISO, Six Sigma, Lean). Well-versed in continuous improvement tools and methods with demonstrated proficiency in implementing and facilitating CI teams. Excellent ability to drive and implement Root Cause and Permanent Corrective Action throughout the organization. 5+ years of quality control/quality assurance experience is required, as well as at least 5 years in a global quality leadership role. Demonstrated success in developing and leading a company-wide quality function. Proven success in driving cultural and organizational change that delivers continuous improvement in customer satisfaction. Ability to bring structure and process to an unstructured environment. Previous experience with consumer packaging is strongly desired. Competence in program, metrics, and measures development. Strong people development and cross-functional collaborative skills. Ability to manage horizontally and vertically; ability to articulate strategy and results to the executive team while enabling understanding of quality objectives throughout the organization. Experience with flexible packaging, rigid packaging, and/or printing processes preferred. If you fulfill these responsibilities, please apply. We offer outstanding compensation, including benefits.

Anova Technical Services is a growing professional service organization headquartered in Indianapolis, Indiana with project locations across the US. Our clients come from various markets such as pharmaceutical, healthcare, agriculture research, chemical manufacturing, industrial and higher education. We provide knowledgeable expertise with proven processes delivered through technology platforms to provide best practices to our clients. Position Overview Quality professionals are critical to Anova's implementation of our quality assurance program. This position is a key component for our continued success and growth in providing professional services to our clients. Individuals should be trained on industry quality standards and are expected to learn, understand, and apply specific quality standards to construction project systems and component installations. Key Responsibilities Conducting Project Quality Observations Field Inspection Auditing Gap Assessments Quality Inspection Record Documentation Contractor Quality Control Plan Review Drawing and Specification Reviews QA/QC Activity Coordination Standard Compliance Reviews Requirements and Qualifications Bachelor's degree in Engineering, Construction Management, or a related discipline, or minimum three (3) years of experience in construction delivery, quality assurance, and/or building commissioning Certifications and training in various fields of mechanical, electrical, and general construction applications Excellent knowledge of construction materials and equipment Experience in building systems, facility inspections, and good documentation practices Excellent written and verbal communication skills Project Management experience with commercial-related projects Experience with computer-based scheduling programs such as Primavera or ASTA At Anova, We Offer: Medical, dental, and vision benefits Dependent Care, Medical Savings Account, and Health Savings account with employer contribution Employee Stock Ownership Plan Fitness Membership Reimbursement Cell Phone Reimbursement Traditional and Roth 401k with company match Generous paid time off and paid holidays Four company-sponsored events a year Life insurance, short & long-term disability. Annual 40% off boot vouchers. ½ price Indianapolis Zoo and Children's Museum memberships Parental Leave Employee Referral Program Many additional voluntary benefits Please note sponsorship and/or relocation are not available for this position. Notice to Recruiters and Agencies: Shiel Sexton prefers to recruit candidates directly, rather than through a third-party recruiter or agency. Do not submit or present your candidate(s) through any means (e-mail, fax, phone, mail, verbal referral) to Shiel Sexton or any employee of Shiel Sexton. In the case of candidate(s) submitted or presented to Shiel Sexton by a recruiter or agency without a signed agreement in place for the specific position or without a specific open requisition, Shiel Sexton explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency. To request consideration as a Recruiting Vendor, please contact our human resources department.

As Manager of Supplier Quality Assurance, you'll be at the forefront of expanding our supplier quality program and leading supplier quality management for all types of biologic drugs for our clients. This is a unique opportunity to shape quality systems, develop a high-performing team, and drive continuous improvement initiatives that directly impact patient safety and product quality. You'll work alongside passionate professionals in a collaborative environment where innovation meets rigorous GMP standards, and where your expertise will be valued and your career growth accelerated. This role encompasses comprehensive responsibility for all aspects of supplier quality assurance, including vendor qualification and management, incoming material inspection programs, supplier auditing, and CAPA management. You'll lead the development and implementation of robust quality systems that ensure compliance with FDA, EMA, and other regulatory requirements while supporting our rapidly growing aseptic filling operations. The successful candidate will build and mentor a team of quality professionals, drive process improvements for enhanced efficiency, and establish strategic partnerships with key suppliers to ensure consistent delivery of high-quality materials and services. Essential Job Functions: Team Leadership & Development: Build, lead, and mentor a team of supplier quality professionals, establishing clear performance objectives, providing ongoing coaching, and fostering a culture of continuous improvement and regulatory compliance Supplier Qualification & Management: Develop and execute comprehensive supplier qualification programs, including risk assessments, audits, and ongoing performance monitoring for raw materials, components, and contract services Quality Systems Ownership: Maintain robust supplier quality management systems, including vendor approval processes, incoming inspection protocols, and supplier scorecards aligned with GMP requirements Regulatory Compliance: Ensure all supplier quality activities comply with FDA and EMA regulations, ICH guidelines, and other applicable regulatory standards Supplier Auditing: Plan and conduct comprehensive supplier audits, including pre-qualification, routine surveillance, and for-cause audits, ensuring thorough documentation and effective CAPA follow-up Process Improvement: Identify and implement process improvements to enhance efficiency, reduce cycle times, and strengthen compliance while supporting the organization's rapid growth trajectory Cross-functional Collaboration: Partner closely with Procurement, Manufacturing, Quality Control, and Regulatory Affairs teams to ensure seamless integration of supplier quality requirements into business operations Risk Management: Conduct supplier risk assessments, develop mitigation strategies, and manage supply chain disruptions to minimize impact on manufacturing operations Documentation & Reporting: Maintain comprehensive supplier quality documentation, generate performance metrics and reports, and present findings to senior leadership and regulatory inspectors Change Control: Evaluate and approve supplier changes, ensuring appropriate risk assessment, validation activities, and regulatory notifications as required Training & Knowledge Management: Develop and deliver supplier quality training programs, maintain subject matter expertise, and ensure team competency in evolving regulatory requirements Special Job Requirements: · Bachelor's degree in Life Sciences, Chemistry, Engineering, or related field · 7+ years of experience in pharmaceutical quality assurance with at least 3 years in supplier quality management · Strong knowledge of FDA regulations (21 CFR Parts 210, 211, 600), EMA regulations, ICH guidelines, and GMP requirements related to quality assurance and quality systems · Experience with supplier auditing, qualification, and ongoing management programs · Demonstrated ability to identify improvements to quality systems and to lead implementation of these improvements · Excellent written and verbal communication skills with ability to interact effectively with suppliers and internal stakeholders Additional Preferences: · Master's degree in relevant field or advanced quality certifications (ASQ, Certified Auditor, etc.) · 3+ years of leadership experience managing quality professionals in a GMP environment · Experience in aseptic filling operations, sterile manufacturing, or parenteral drug products · CDMO or contract manufacturing experience Additional info about INCOG BioPharma Services: At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. By submitting your resume and details, you are declaring that the information is correct and accurate.

Job Title: Manager, Batching & Quality Control Department: Management Reports to: Director of Operations We are seeking a highly organized, proactive, and culture-focused Batching & Quality Control Manager to join our team. This role will oversee two of the critical departments that enable Circle Beverage to uphold our core values of: (1) taking care of people, (2) delivering on our commitments, (3) choosing the high road, and (4) being nimble. This position is responsible for a 24-hour team that oversees the batching process (6 team members) and the quality control process (3 team members) for the company. Key Responsibilities: Batching process ● Accountable for the end-to-end batching process, which includes pick lists, kitting, batching, blending, spec signoff, and preparation for packaging. ● Direct supervisor for the Batching Technicians. ● Responsible for the batching room, all batching equipment, and other assets of the batching department. ● Owns all SOPs related to the batching department and process. ● Accountable for food safety, quality, and sanitation activities across the department. Quality Control process ● Accountable for the end-to-end quality control process, which includes hourly FSQA checksheets, product inspections, seam checks, fill level checks, batch spec signoff, sensory, and more. ● Conducts internal audits to identify process gaps, and participates in the process to close those gaps. ● Works alongside the Quality Assurance Manager to support regulatory, compliance, customer, and other requirements. ● Direct supervisor for the Quality Control technicians. ● Responsible for the quality control lab and all equipment and assets of the lab and QC process. ● Owns all SOPs related to the companywide quality control process. ● Accountable for food safety, quality, and sanitation activities across the department. Leadership & Culture ● Lead, develop, and grow the direct reports of the department. ● Invest in the performance and growth of the direct reports of the department. ● Be a force for driving the company culture across the department. ● Accountable for team member performance and engagement across a 24 hour operation. Is able to work a flexible schedule to periodically be present on each shift, to allow for personal coaching, develop, and interaction with all team members. Continuous improvement ● Develop and oversee an internal continuous improvement (CI) process for the company. Safety ● Develop and oversee the internal Safety committee and initiatives for the company. Qualifications: The experiences that a qualified candidate will have are: ● At least three years of experience as a supervisor or manager in beverage manufacturing with direct experience overseeing activities such as blending, batching, brewing, and quality control of a 24-hour manufacturing operation. ● You have exhibited mastery in developing skilled employees to achieve self-sufficiency, certifications, and developed into future leaders. You have experience with performance-managing people out and managing others up to a higher level of performance. ● You have led continuous improvement initiatives within a LEAN, Six Sigma, or comparable program. Preferred: you hold a certification in one of these improvement methodologies. ● You have been trained in food safety, quality control, GMP's, and other relevant regulations. Preferred: you hold a PCQI certification. ● You have a history of using data and structure to drive discipline within your teams. What We Offer: ● A collaborative and inclusive team environment. ● Opportunities to grow and take on new challenges. ● A chance to make a meaningful impact on company culture and employee experience.

The Quality Control Manager is responsible for the implementation and maintenance of the quality management system for heavy mechanical industrial projects, civil, and structural steel. Responsibilities include managing and scheduling third party testing subcontractors. Must be able to work out-of-town projects when required. RESPONSIBILITIES Ensures that a safe workplace remains a top priority by partnering with Safety to support policies, procedures, and practices for establishing a safe workplace. Prepares, controls, and supervises the company's QA manual control, all amendments, and revisions. Controls and distributes all company quality documentation. Monitors all quality related activities on the project. Attend client quality management meetings. Manages and schedules third party testing subcontractors. Prepares and controls project quality system management documentation prior to project commencement. Reviews quality inspection personnel qualifications and training requirements. Monitors the disposition of all issued nonconformance reports. Monitors the progress and effectiveness of the project quality management system; recommends and implements improvements. Coordinates all QA/QC activities with the site QC tech. Coordinates with customer representatives on all quality matters. Proactive in all areas of safety and recognizes potential safety issues/hazards. COMPETENCIES Business Literacy: understands the line of business, takes the business vision, and translates it into the project vision. Corporate Procedures and Tools: understand and apply established policies and procedures, corporate tools, and requirements to the project. Knowledge of weld procedure, weld qualifications, associated codes for industry. Communications: produces clear status reports, writes clearly, communicates tactfully and candidly, exhibits clear verbal skills and an excellent listener. Financial Acumen: understands how decisions affect the bottom line; understands performance, general financial and accounting principles and practices that affect operations; and knows about the links between operations and the department's financial performance which is essential to create value for all the organization's stakeholders. Leadership: motivates project members, sets achievable objectives, maintains a positive outlook, takes responsibility, makes decisions, and provides constructive feedback. Time Management: manages competing priorities effectively, is resourceful and uses time as a resource. Environmental, Health and Safety Management: understands and knows how to comply with all regulations; implements a positive attitude toward health and safety in the design and execution of the project; ensures safe deliverables and incorporates sustainable development practices. QUALIFICATIONS Education/Experience: Bachelors' (B. A. or B.S.) from four-year college or university in Engineering or Construction Management and at least seven years' experience with Quality Assurance/Quality Control in Industrial Construction; or 12 years' experience as CWI or 15 years of combination of experience as CWI and experience as pipe welder. Current CWI license is required. Language Ability: communicate clearly and effectively to manage and motivate staff individually and as a team. Spanish proficiency is preferred. Reasoning Ability: must have a record of impartial, objective analysis, approaching issues with an open mind; be able to identify viable solutions that are technically and conceptually sound. Working knowledge of standard construction practices and law. Computer Skills: knowledge of and experience with HCSS HeavyBid, Excel, and CAD Must be legally authorized to work in the United States. Must be able to pass a criminal background check and drug screen. Must be able to travel nationally. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to frequently inspect the project and may be exposed to ongoing construction and various weather conditions. The noise level in the work environment may range from moderate to loud. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision and color vision. The employee is occasionally required to sit in a vehicle up to 8 hours. The employee is occasionally required to reach with hands and arms. The employee is occasionally required to climb or balance, stoop, climb ladders, board boats, kneel, crouch and/or crawl. The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions and perform any other related duties as assigned by their supervisor. Powered by ExactHire:191289

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network. The purpose of this position is to provide oversight and drive / maintain harmonization of technical programs that govern implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Network. This position also influences peers within Lilly globally and at the site level, as well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and enables building technical capability at Lilly sites to ensure the vital capabilities are developed and in place to meet business objectives. Finally, this role provides ad-hoc technical support to Lilly PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. Responsibilities: Assess differences in current sterility assurance programs across the sites and drive harmonization Work closely with site and multi-functional SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. Assume SME leadership role for a specific topic area within Sterility Assurance across the network, including harmonization of aspects of the topic area and facilitation of the knowledge across the network. Represent TS/MS on network Science Lead Team and other appropriate governance forums. Ensure that Sterility Assurance programs and similar topics are frequently presented to network team in order to align across sites. Ensure that learnings and best practices are shared across sites: set-up appropriate forums in order to achieve this and present case studies to site SMEs. Provide mentoring leadership to site SMEs to help build continue to build capability, particularly at the newer sites or where deep technical expertise is lacking. Building, maintaining, and growing capability across the organization in the sterility assurance space Provide technical support to new sites/ filling lines during design and start-up activities to ensure sterility assurance programs and process/ product requirements are supported at these sites, particularly while the sites are in early stages of building capability. Provide technical support for significant sterility assurance investigations to help identify root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across the other sites. Benchmark industry trends and emerging regulatory guidance / requirements in the field through building an extensive peer network and attendance at relevant industry and regulatory meetings and advocacy groups. Advance Lilly agenda in the field. Represent Lilly on relevant external bodies related to Sterility Assurance; be influential in terms of representing Lilly's position on technical/ regulatory positions papers and guidance. Assess new technologies to ensure Lilly stays current with new trends and technologies and share with the network with the goal of staying current with industry best practice. Work with PR&D on new technology / platform development and implementation for pipeline products. Influence the agenda within PR&D to ensure the needs of Manufacturing are met, and the control strategies are fit for-purpose for robust and compliant commercial manufacturing. Provide ad-hoc technical support to Lilly organizations outside of the PPN including PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. Engage in providing support during regulatory interactions such as RtQ of submissions, and on-site inspections Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals Basic Qualifications: BS Degree required. MS/PhD in a biological science preferred. 10+ years' experience working in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles preferred. 10+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment preferred. Deep technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, Annex 1 interpretation) Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities Strong written and oral communication skills Ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance Demonstrated experience influencing site and network leaders to advance technical agenda projects Additional Preferences: Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed. Support the establishment of a sterility assurance network or hub in global TSMS Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance Experience in leading external committees or conferences to ensure Lilly remains a leader in the sterility assurance space Work with engineering SME's to support Lilly platforms to maximize the performance and minimize the risk of sterility assurance Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options. Strong capability to influence personnel and management across the organization Close interaction with quality to enable internal audits that identify risks Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance. Additional Information: Approximately 25% travel Lilly currently anticipates that the base salary for this position could range from between $133,500 to $220,000 and will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $133,500 - $246,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Plans, coordinates, and directs the quality control program designed to ensure continuous production of products consistent with established standards. Plays active role on quality management teams within the organization. Designs and implements quality control training programs to key personnel in conjunction with managers. Fulfills supervisory responsibilities in accordance with the organization's policies and applicable laws. Job Duties: Develops and analyzes statistical data and product specifications to determine present standards and establish proposed quality and reliability expectancy of finished product. Formulates and maintains quality control objectives aligned to corporate policies and goals. Creates and implements inspection criteria and procedures. Interprets quality control philosophy to key personnel in the organization. Coordinates objectives with production procedures in cooperation with other plant managers to maximize product reliability and minimize costs. Provides inspection activity for products throughout production cycle. Applies total quality management tools and approaches analytical and reporting processes within each department. Directs workers engaged in inspection and testing activities to ensure continuous control over materials, facilities, and products. Works with vendors to ensure quality of all purchased parts for company use. Other duties as assigned. Job Qualifications: Bachelor's degree in manufacturing management or industrial engineering, Quality Management, or a related field preferred and/or Lean Six Sigma Certification preferred. Five to seven years of experience in a similar role Must have organizational skills with an ability to prioritize and multi-task. Ability to maintain confidentiality, exceptional attention to detail and good follow-up skills. Must have good problem-solving skills. Ability to interact in a professional manner with employees and vendors. Ability to communicate effectively both verbally and in writing. Proficient in Excel and Word Willingness to work as team member or independently. Must be committed to continuous improvement.