Quality assurance manager jobs in Chula Vista, CA - 259 jobs

A biotechnology firm located in San Diego, California, is seeking a Director of Quality Assurance to lead the QA function. The role involves developing and implementing GxP quality systems, ensuring compliance with regulatory requirements, and driving continuous improvement. Candidates should have at least 7 years of experience in Quality Assurance within the pharmaceutical or biotech sectors and possess extensive knowledge of GxP regulations. This position offers competitive compensation and employee benefits in a collaborative environment. #J-18808-Ljbffr

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others The Director, Quality Assurance (GCP) oversees the development, implementation, maintenance, and performance of GCP Quality Assurance systems both within company and external vendors. The Director will execute and/or ensure proper oversight of the GCP QA audit program management, clinical operations phase 1 to phase 4 study team support, regulatory inspections, and GCP QA infrastructure development.**ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:**These may include but are not limited to:General* Provide GCP quality assurance strategy and oversight of QA GCP operations* Ensures that clinical trials and research activities adhere to regulatory requirements, industry standards, and internal policies* Develop and implement risk management strategies to identify, assess, and mitigate risks* Drive effective initiatives that foster a culture of quality and continuous improvement* Successfully collaborate on multiple projects with cross-functional stakeholders* Lead investigations of significant complexity* Prepare and present to executive management* Manage, lead, and mentor quality assurance team members; lead cross-functional teams on compliance projects Audit Management* Develop a plan with CROs for clinical sites' audit execution* Manage clinical site, TMF, and GCP and GLP vendor audit activities* Generate and/or review and approve overall GCP QA audit plans and schedules* Generate and/or review and approve audit trend reports* Execute the GCP QA audit program to ensure that processes and systems are adequate for communicating, addressing, and preventing identified GCP compliance issues and trends Study Team Support & Issue Escalation Management* Represent QA at program-wide (e.g., study team or governance) meetings and provide GCP guidance and feedback* Serve as point of escalation for GCP compliance issues identified by clinical study teams or QA leads, and responsible for informing the head of QA and Management, as required* Manage quality events, CAPAs, and deviations* Collaborate with cross-functional teams (Clinical Operations, Clinical Research, Regulatory, etc.) to embed quality by design in clinical programs.* Provide guidance and support to Trial Master File activities Quality Systems / Inspections / Infrastructure* Ensure adequate systems and controls are in place for GCP compliance* Identify and address quality systems gaps, including internal processes and personnel GCP training* Execute the review of GCP SOP tracking and status reports to ensure timely review and development of SOPs* Author, review, or revise SOPs related to clinical and non-clinical studies* Develop and provide GCP training* Support regulatory inspection activities* and GCP inspection readiness activities* Prepare internal team, clinical sites, and vendors for inspection readiness* Thoroughly review clinical study documents* Perform breach assessments* Oversee quality vendor management and governance for GCP and GLP vendors* Review Quality Agreements to ensure clear delineation of responsibilities and compliance expectations between the sponsor and the vendor* Contribute and present GCP quality events and metrics at the Quality Management Review meeting* Support other Quality Assurance and Quality Systems activities* Other duties as assigned.**Education and Experience**Required:* Minimum Bachelor's degree in a science discipline and at least 12 years' experience in a QA function within the pharmaceutical/biotech industry (an equivalent combination of experience and education may be considered)* Minimum of 8 years of working in a GCP QA function* Previous experience leading inspection readiness and audits* Thorough understanding of FDA, EU and local regulations, as well as understanding of ICH guidelines* Hands-on experience in developing and implementing GCP procedures* Strong working knowledge of GCP and GLP regulations* Proven ability to cultivate and develop relationships with cross functional teams and vendors* Demonstrated leadership ability to identify, manage and develop QA teams* Must be able to make critical and strategic decisions based on risk-assessments* Capable of managing multiple projects simultaneously* Excellent communication and listening skills Preferred:* Auditing certification is a plus**Physical Demands and Work Environment:**Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.**Travel:**You may be required to travel for up to 10% of your time.**The Anticipated Base Salary Range: $1****76,000 - $220,000***In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.*The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.**Equal Opportunity Employer:**Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.**Vaccination requirement:**Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone #J-18808-Ljbffr

About the job Type: Full-Time, Direct Hire NCC Talent Solutions is proud to partner with a growing CDMO biotech startup in San Diego to identify a Head of Quality who will play a critical leadership role in building, scaling, and safeguarding the company's Quality function during an exciting phase of growth. This is a high-impact opportunity for a quality leader who enjoys rolling up their sleeves, setting standards, and serving as a strategic partner to the business while ensuring compliance with global regulatory expectations. About the Role As the Head of Quality, you will lead the Quality Assurance organization and serve as the primary QA representative across internal teams and external partners. You will be responsible for establishing, maintaining, and continuously improving the Quality Management System (QMS) in alignment with FDA, EMA, and ICH GMP regulations, while supporting regulatory inspections, customer audits, and submissions. Beyond compliance, this role is instrumental in driving operational excellence-reducing waste, improving efficiency, and embedding quality as a core business enabler as the organization scales. Key Responsibilities: Leadership & Strategy Lead, mentor, and develop the Quality Assurance team. Serve as the QA representative for assigned programs at the management and external stakeholder level. Oversee all QA programs and projects, ensuring cross-functional alignment and on-time execution. Provide leadership in the design and continuous improvement of QA processes, systems, tools, and organizational structures. Quality Systems & Compliance Establish, implement, and maintain a robust Quality Assurance System. Ensure internal documentation and processes comply with applicable regulatory requirements. Translate evolving regulatory expectations into practical internal quality standards. Independently monitor and assess the effectiveness of the QMS. Operational Quality Oversight Partner closely with internal departments and external service providers to uphold quality policy. Own and manage the company's documentation control system, including creation, review, approval, and maintenance of GMP documentation. Lead deviation management, CAPAs, and change control processes. Support and participate in internal audits, customer audits, regulatory inspections, and contractor audits. Review and approve qualification and validation plans and batch releases. Process Ownership & Continuous Improvement Act as process owner for assigned quality processes, including: Regular review and optimization of processes Ensuring appropriate training and readiness of impacted employees Staying current on regulatory trends, guidance, and industry best practices Serving as the primary point of contact during audits and inspections Desired Qualifications Education Bachelor's degree (or higher) in Pharmacy, Biotechnology, Natural Sciences, Engineering, or a related field, or equivalent professional experience. Experience & Expertise Minimum of 5 years of experience in Quality Assurance in a GMP-regulated environment, preferably with experience with aseptic processing. Strong working knowledge of bioprocessing, manufacturing, and analytical operations. Demonstrated leadership or people-management experience. Experience supporting regulatory inspections and audits. Skills Strong written and verbal communication skills in English. Ability to balance strategic thinking with hands-on execution in a fast-paced, growth-stage environment. Why This Role This is a rare opportunity to shape the Quality function from the ground up within a growing CDMO, with direct influence on compliance, culture, and long-term success. The Head of Quality will be a trusted leader and partner to the business, with visibility, autonomy, and the ability to make a lasting impact. NCC Talent Solutions is managing this search on behalf of our client. All inquiries and applications will be handled with discretion.

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.**We are PCI.**Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.**Summary of Objective:** The Director of Quality is tasked with defining and promoting a quality mindset across the entire site. This position is responsible for the direction and oversight of all Quality efforts and compliance functions at PCI Pharma Services. As a member of the Site Leadership Team, this position works directly with the Site General Manager to create and sustain a culture of Safety, Quality performance, Operational Excellence, continuous improvement, error reduction, regulatory compliance, and sound fiscal responsibility. The Director of Quality leads the development of site Quality Objectives, site Quality Plans, Quality Management Reviews, etc. Major responsibilities include the alignment of Quality objectives, driving proactive improvements into the organization, coaching and mentoring, and the establishment and maintenance of policies and standard operating procedures. This position will ensure customer requirements, cGMP requirements, and all foreign and domestic regulations are accurately incorporated into PCI's Quality Operations.**Essential Duties and Responsibilities:*** Direct strategy and efforts for Quality and continuous improvement programs that is in compliance with regulatory and customer expectations, which includes developing and maintaining “Best-in-Class” Quality Standards and associated policy and work practices.* Direct oversight for quality improvement efforts that bring improved performance and regulatory compliance to selected activities within the organization.* Ensure strong alignment and coordination with business units and other functional groups. Collaborate on best practices with other Quality leadership team members.* Develop Quality team members, with a focus on continuous organizational growth. Oversee proper training, goal setting and effective organizing and assigning of work.* Ensure effective and timely communication of issues to appropriate levels of management.* Collaborate with the appropriate Account Executive to coordinate and facilitate client Quarterly Business Reviews.* Design, maintain and continually improve the Quality operations and systems in line with current national and international standards. Serve as the public-facing Quality Subject Matter Expert (SME) for PCI Pharma Services* Develop and manage department budgets, schedules and performance requirements and evaluations.* Ensures Quality representation on cross-functional and multi-site teams to support integrating risk management into various product quality systems.* Drive harmonization efforts with other global PCI Pharma Services facilities and operations, and create appropriate work standards for harmonization efforts.* Participate, present and provide rationale for the Quality operations during periodic audits and regulatory inspection and customer visits/conference calls as required.* Participate in Operational Excellence projects as necessary* Establish and build relationships with our current customer base in order to enhance their perceptions of the PCI Quality organization.* Ensure that all deviations are comprehensively investigated, the appropriate corrective and preventive actions are installed, and the investigation is closed out on time.* Participate in customer focused meetings or kick off meetings in order to secure and define the scope of new projects* Internal Investigations on cGMP issues, trends, and customer complaints* Review and approve GMP documentation, including SOPs, Manufacturing Batch Records, validation protocols and reports, and executed Batch Records for cGMP compliance and clarity* Process integration and procedural harmonization with other PCI sites* Customer and Regulatory Audits, including coordination and submission of PCI's responses* Communication and escalation of quality issues to Site Leadership Team and QA senior management* Supplier and internal audits* Implement Global quality policies and standards and PCI network procedures at the site* Continuous process improvements, particularly as a function of site deviation rate and recurrent deviation rate* Maintain robust relationships, interactions, and communications with client QA counterparts* Facility/equipment/process/analysis method/cleaning validation and qualification program* This position may require overtime and/or weekend work.* Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.* Attendance to work is an essential function of this position* Performs other duties as assigned by Manager/Supervisor.* The position must have experience in clinical trials with high standards of working, best practices and cGMP knowledge to ensure operational excellence and effective risk management.**Qualifications:****Required:*** Bachelor's Degree in a related field and/or 7-10 years related experience and/or training.* Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.* Math Skills Required.* Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.* Highest Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems and deal with nonverbal symbolism in its most difficult phases while dealing with concrete/abstract variables.* Ability to Travel* Ability to adapt to changing work environments.The base salary hiring range for this position is ($151,360 - $170,280) plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). #LI-AK2Join us and be part of building the bridge between life changing therapies and patients.**Equal Employment Opportunity (EEO) Statement:** *PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.**At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.*###At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. #J-18808-Ljbffr

The Quality Systems and Regulatory Staff Lead ensure robust governance and execution of post-market quality processes, including CAPA management, issue impact determinations, field action decisions and follow-ups. This role evaluates quality signals to determine escalation, aligns investigations and corrective actions with regulatory requirements, and partners cross-functionally to scope field actions, collaborates and provides feedback on the Post Market Risk Assessment and Health Hazard Evaluation (HHE) process and facilitates its completion, and delivers data-driven insights for decision-making. Additionally, it manages regulatory communications such as FDA responses, drives continuous improvement across the quality system, and leverages analytics to monitor KPIs, identify systemic issues, and implement timely, validated solutions that uphold product safety, compliance, and customer trust Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Key Responsibilities: Support the development, execution, and governance of remediation and prevention strategies as well as post market issue impact/risk assessments. Ensure alignment with regulatory requirements and internal quality standards. Evaluate potential issues before formal CAPA initiation. Conduct structured evaluations of quality signals, complaints, audit findings, and other inputs to determine whether formal CAPA is warranted. Ensure that issues are appropriately prioritized, risk-ranked, and moved forward based on impact and recurrence. Partner with multiple functional areas to gather relevant data and context, enabling informed decisions and timely initiation of CAPA when necessary. Confirm that CAPA investigations are directly tied to the reason for the recall. Ensure that corrective and preventive actions are appropriate, mitigations are suitable, and implementation plans are robust. Verification of effectiveness (VOE) plans must be clearly defined, thoroughly tested, and documented to demonstrate sustained resolution of the issue. Support comprehensive issue impact and risk evaluations (SAs). Help teams apply a risk-based method to prioritize process and product issues, actions, and partner concerns for the field action committee. Facilitate discussions with medical affairs and other relevant function to understand issue's impacts on patients, business operations, and regulatory compliance, quantify risk levels, and deliver actionable recommendations that enable informed decision-making and proactive mitigation strategies. Ensure HRA or HHE alignment by collaborating with cross-functional teams to determine the scope of field actions. Facilitate HRAs or Health Hazard Evaluations (HHEs) to assess clinical risk and support decision-making. Partner with cross functional teams to help them develop and deliver clear, data-driven presentations to the committee deciding the field actions. Support alignment on issue impact assessments/risk assessment, scope definition, and mitigation strategies for recalls and related actions, enabling informed and collaborative decision making. Draft and coordinate responses to FDA warning letters, field action inquiries, and other regulatory correspondence. Ensure timely and accurate updates on mitigation activities. Drive End-to-End Process Improvements Throughout the Quality System: Identify inefficiencies and gaps across the quality lifecycle. Lead initiatives to streamline processes, enhance compliance, and improve overall system performance. Support the successful execution of field corrective actions by ensuring solutions are readily available and thoroughly validated. Ensure solutions are accurately released and fully aligned with all applicable regulations and standards. Leverage data analytics to uncover opportunities for benchmark and KDG refinements by analyzing quality trends (15% of the time). Use advanced tools to monitor performance indicators, detect systemic issues, and propose targeted improvements. Lead weekly and daily management meetings with team members to evaluate metrics, foster accountability, and align on improvement strategies. Maintain continued transparency through multifaceted tracking and reporting of key performance measure Background and Experience: Bachelor's Degree in Engineering, Life Sciences, or a related technical discipline. Minimum 7 years of progressive experience in medical device Quality Assurance, with a proven track record of compliance excellence. Minimum 5 years of hands‑on risk management expertise, including a deep understanding and practical application of ISO 14971 principles. Demonstrated experience in direct communication with FDA, including drafting and managing regulatory responses and correspondence. Comprehensive knowledge of global quality and regulatory standards, including ISO 13485, ISO 9001, 21 CFR Part 820, and EU MDR, with the ability to interpret and apply requirements effectively. Proven leadership capabilities, including driving cross-functional collaboration, influencing stakeholders, and leading complex quality initiatives. Strong analytical, problem‑solving, and decision‑making skills with the ability to manage multiple priorities. At BD, we prioritize on‑site collaboration because we believe it fosters creativity, innovation, and effective problem‑solving, which are essential in the fast‑paced healthcare industry. For most roles, we require a minimum of 4 days of in‑office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work‑life balance. Remote or field‑based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID‑19. In some locations, testing for COVID‑19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally‑protected characteristics. Primary Work Location USA CA - San Diego TC Bldg C&D Salary Range Information $155,900.00 - $257,300.00 USD Annual Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field‑based and Remote roles. Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. #J-18808-Ljbffr

GVI Inc., a subsidiary of Three Saints Bay, LLC, and a Federal Government Contractor industry leader, is seeking a Quality Assurance Manager (Depot) in San Diego, CA. High School Diploma & 5 years in restoration/repair depot. 5 yrs experience in restoration/repair depot with emphasis on managing quality management systems. Qualified as a Lead Auditor for ANSI-Z540.1, ANSIZ540.3, or ISO 17025. Compensation: $100K - $150K Position is located in San Diego, CA. VEVRAA Federal Contractor Three Saints Bay, LLC and its subsidiaries offer a team-oriented working environment and the opportunity to work with exceptional, dedicated industry professionals. We offer our employees a comprehensive benefits package and the opportunity to take part in exciting projects with government and commercial clients, both domestic and international. We are an Equal Opportunity Employer. We invite resumes from all interested parties without regard to race, color, sex, sexual preference, religion, creed, national origin, age, genetic information, marital or veteran status, disability, or any other category protected by federal, state, or local law.

Kinovate Life Sciences, Inc. established in 2004 in Oceanside, California. A wholly owned subsidiary of Nitto Denko Corporation (*************** Kinovate was spun-off from Oceanside, CA based R&D facility Nitto Denko Technical Corp (**************** with a mission to provide the highest quality materials to niche life science markets worldwide. Since its inception, Kinovate has grown to become the market leader in solid support in the oligonucleotide synthesis field. We are bringing the most creative minds in science and technology to develop medical discoveries and breakthroughs. Our customers are well-known in the biotechnology industry. We are in a growth phase within ISO work environment and leading towards a GMP Certification. KLS is seeking extraordinary people to join the team. KLS is proud to be an equal employment opportunity employer. Why Work Here Great place to work. Small subsidiary of large international company headquartered in Japan. Generous discretionary bonuses. Health, dental, vision, life, and disability insurance effective from date of hire. Additional benefits include 401(k), 3 weeks vacation in your first year, 12 paid yearly holidays, 5 paid sick days, tuition reimbursement and more. JOB SUMMARY: Under strategic leadership, sustain the improvement of the Quality Management Systems (QMS) and manages the development of quality assurance & systems staff. Utilize the following industry standards to drive high-quality products: Current Good Manufacturing Practice (cGMP), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), and International Organization for Standardization (ISO). Facilitate employee relations issues including coaching, mentoring, and disciplining including performance evaluation of employees. Provides strong leadership to motivate, guide and inspire employees to meet the organization's business objectives with production. Lead the implementation phase of MasterControl, ensuring successful implementation, and post-implementation management. ESSENTIAL DUTIES and/or RESPONSIBILITIES: Partners with leadership to develop the Quality Management System (QMS) and ensure it is compliant with relevant regulations, including ISO 9001, 21 CFR Part 210 and 211, ICH, and other applicable national and international regulatory guidelines.Ensure the QMS always remains in an auditable state. Oversees the daily operations of the QMS, ensuring it runs efficiently and in compliance with quality standards. This includes managing critical quality systems processes such as Incoming Raw Material Receipt, Raw Material Review/Disposition, Final Product Review/Disposition. Manages quality events and investigations including but not limited to Deviations, CAPA, Change Control, OOS, OOT, Customer Complaints, including leading and facilitating cross-functional meetings to ensure proper assessments and actions. Ensures QA review of Validation/Qualification activities including protocols, execution, and reports. Upholds timely response to events and on-the-floor QA support(MQA), including ensuring the MQA program is tracked and measurable. Leads the transition of QMS programs, such as Quality Events (Deviation, CAPA, Change Control, OOS, OOT), Audits and Supplier Qualification transition into Master Control, and serves as the System Administrator. Administers post-implementation management of MasterControl, including, but not limited to, system optimization, performing troubleshooting support, managing software updates, and continuously improving system functionality to meet evolving regulatory needs. Reports key metrics for QA Operations turnaround times and Quality Events. Contributes to the continuous improvement initiatives related to the QMS, collaborating with cross-functional teams to optimize quality processes. Analyze quality data and metrics to identify trends, root causes, and areas for process improvement within manufacturing and quality control activities. Develops standard operations and other quality documents related to QMS and ensure all documents meet regulatory requirements and internal standards. Supervises and develops a team providing guidance, training, and support to ensure compliance with regulatory standards and best practices. Mentors and develops a team of the QA team, fostering an environment of accountability and growth. Ensures cross-functional collaboration and provide effective leadership managing the QMS processes and ensures effective employee relations. Facilitates training initiatives to ensure that team members are adequately prepared to handle QMS functions and sustain a flexible workforce. Fosters a culture of continuous improvement, supporting staff development and efficiency improvements within the quality systems team. Conducts performance reviews for direct reports. Institutes timely corrective actions and interfaces with Leadership and HR in developing disciplinary actions up to and including terminations. Administers time-keeping functions to track absenteeism; approves timecards on a bi-weekly basis. SUPERVISOR RESONSIBLITIES: Quality Assurance Associate Quality Assurance Specialist Sr. Quality Assurance Specialist MINIMUM EDUCATION and/or EXPERIENCE: Bachelor's degree in a scientific discipline; and five (5) years' directly related experience in a Good Practice (GXP) or ISO manufacturing-controlled environment or equivalent combination of education and experience. Experience in transitioning from paper based to electronic QMS. KNOWLEDGE, SKILLS and/or ABILITIES: Working knowledge of pharmaceutical industry concepts, as well as analytical methods and writing skills, including documenting manufacturing processes, a plus. Familiarity in Lean or Six Sigma, a plus. Strong Knowledge of quality management principles and practices, including ISO 9001 and cGMP standards. Proficient in the use of quality management software with experience in implementing or managing MasterControl being highly desirable. Experience conducting technical investigations with formal root cause analysis tools. Prior supervisory experience, preferred. Knowledgeable of change control, validation/qualification, and method development and tech transfer. Strong knowledge of formal root cause analysis and risk assessment tools. Ability to lead or facilitate investigations and/or risk assessments. Strong application of critical thinking skills along with problem solving and creative skills to identify manufacturing issues for continuous improvement. Strong multi-tasking skills, flexibility in responding to rapidly changing, dynamic processes and demands/pressures in a fast-paced environment. Strong ability to verbally communicate across functional organizational groups, provide high-level customer service through effective interpersonal skills and conflict resolution, including communicating with equipment suppliers to obtain input on equipment modification and improvement. Microsoft Office Suite software applications such as Excel, Word, Power Point, and other enterprise software applications such as Net Suite, LIMS, and Familiarity with statistical analysis tools. Strong language skills with the ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or government regulations. Write clear processes, manuals and reports for management review and present technical information in understandable terms and respond to questions from groups of customers, employees and/or public. Work independently as well as in a small and/or large group and foster cooperation in a team environment using interpersonal skills to document working knowledge. Work in a detail-oriented environment with strong follow-up, follow-through, and organizational skills. CERTIFICATES and/or LICENSES: American Society for Quality Certified, a plus. Certified Quality Engineer, a plus. Certified Quality Auditor, preferred. PHYSICAL DEMANDS and/or WORK ENVIRONMENT: (Typical physical demands and the work environment characteristics an employee must meet and encounter while performing the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.) Works in a typical office environment with prolonged periods in front a computer entering or researching data. Regularly required to sit; use hands to finger, handle or feel and talk or hear. Availability and willingness to travel if required for audits, inspection, vendor management or if requested to visit or attend a business transaction as legal agent of the company. Must be able to work extended hours per the demands of the business.

Sr. Staff Software Test Engineer - NextGen ERP Test Lead page is loaded## Sr. Staff Software Test Engineer - NextGen ERP Test Leadlocations: US - California - San Diegotime type: Full timeposted on: Posted Todayjob requisition id: 41470-JOB## At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.## Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.## **Location**San Diego, CAOur NextGen ERP Transformation team is seeking a Test Lead who is passionate about continuous improvement and innovation. As a pivotal member of Illumina's transformation initiative, you will lead testing and quality assurance for the migration from SAP ECC to S/4 HANA, ensuring the successful delivery of program objectives. Join us in driving transformation, quality, and innovation at Illumina.* In this role, you will leverage your expertise to refine processes, drive impactful results, and uphold operational excellence. Collaboration is central: you will work closely with internal teams, key stakeholders, and our System Integrator to achieve project milestones. Your leadership will guide teams through sophisticated testing methodologies, facilitate seamless integration of business applications, and contribute to best practices in testing tools and strategies.* As Illumina's SAP Test Lead, you will plan, execute, and oversee comprehensive testing of SAP systems and supporting platforms such as Salesforce, guaranteeing compliance with business requirements and quality standards. You will champion standardized practices in software development and testing.* Essential qualifications include deep expertise in SAP modules, proficiency with test management tools, and exceptional leadership and communication abilities. This position is core to the enterprise team tasked with migrating Illumina's SAP ECC platform to S/4 HANA, shaping the future of our business systems and processes.**Key Responsibilities*** **Strategy & Planning**: Design and implement comprehensive testing strategies for SAP S/4 HANA solutions to meet business objectives. Define and implement the overall SAP automated and manual testing strategy for all phases - including unit, integration, system, regression, and User Acceptance Testing (UAT). Clearly communicate the goals and objectives of the testing program to the broader program team.* **Team Leadership**: Lead and mentor a cross-functional team of testers, including a global team of system integrator testing resources. Ensure effective resource allocation, provide performance feedback, and oversee the entire SAP testing project lifecycle. Act as a strategic advisor on the ERP initiative, leveraging team members and the System Integrator team to achieve key milestones are deliver quality results. Facilitate collaboration, bring the right people together, and escalate appropriately to resolve any complex problems and challenges.* **Test Execution & Coordination**: Oversee the testing and implementation of the SAP S/4 HANA from the ECC including all ancillary systems and applications. Plan and execute test strategies, manage testing teams, collaborate with stakeholders, and ensure that testing outcomes align with business goals. Validate outcomes with team, share alternative perspectives, and act on feedback.* **Stakeholder Collaboration**: Maintain operational excellence while engaging with key stakeholders. Identify opportunities for improvement in security, controls, and processes within SAP environment. Monitor test progress, report on defect trends, risks, and issues to senior management and other key stakeholders across the program.* **Reporting & Communication:** Communicate the holistic view of progress. Prepare clear and concise reports and presentations to communicate status, findings, risks, and recommendations to the program team and stakeholders.* **Quality Assurance & Compliance**: Ensure all testing processes and deliverables comply with quality standards, regulatory and audit requirements, project governance, and adhere to Illumina's standards and best practices. Guide teams through intricate testing methodologies and business application integration.* **Process Improvement**: Contribute to thought leadership on testing tools and industry practices. Drive initiatives for test automation and continuous improvement to enhance testing efficiency and effectiveness. Continuously improve test automation frameworks and testing processes. Innovate and refine testing processes to achieve exceptional results.* **Risk & Issue Management:** Apply systems thinking to identify underlying problems and/or opportunities. Identify, manage, and escalate project risk factors and issues that arise during testing throughout the multi-year initiative.**Required Skills and Experience**You will leverage your influence, expertise, and leadership skills to deliver quality results, motivating and coaching others to solve complex problems collaboratively. By exercising sound judgment, you will recognize when to take action and when to escalate. Your ability to navigate complexity, ask insightful questions, and clearly articulate how components fit together is crucial. Commitment to developing and sustaining high-performing, diverse, and inclusive teams, paired with a drive for excellence, will support your success.* **SAP Expertise:** Deep knowledge of SAP business processes, configuration, and integration points, especially with solutions such as S/4HANA, MDG, ECC, and others.* **Analytical & Technical Skills:** Experience utilizing data analytics tools and automation to enhance testing efficiency and analyze results.* **Test Management Tools and Methodologies:** Proficiency with industry-standard tools, including Worksoft, ValGenesis, and Atlassian's Jira/Confluence. Proficiency in manual and automation related to unit, integration, user acceptance (UAT), and regression testing approaches.* **Leadership & Communication:** Excellent mentoring and interpersonal skills, with the ability to convey complex technical concepts to both technical and non-technical audiences.* **Analytical & Problem-Solving:** Strong ability to tackle complex testing challenges and resolve unforeseen issues.* **Project Management:** Experience in end-to-end test management: planning, coordinating, and executing test activities within SAP environments; adept at guiding projects from initiation to completion.**Required Qualifications*** 8+ years of experience in progressive roles managing IT teams including quality assurance and controls with software/systems development processes* Typically requires a minimum of 12 years of related experience with a Bachelor's degree; or 8 years and a Master's degree; or equivalent experience.* SAP ECC experience along with manual and automation testing and quality assurance experience leading test methodologies and business application integrations* Strong knowledge of software QA methodologies, tools, and processes and familiarity with testing frameworks and tools including expertise in automation tools and scripting languages* Experience working in Agile/Scrum development environments* Experience with testing frameworks and CI/CD pipelines**Preferred Qualifications*** SAP S/4 HANA experience* Bachelor's Degree in Information Technology, Computer Systems Analysis, Management Information Systems preferred* Experience with ancillary systems like Salesforce, Workday and iCertis* Experience with #J-18808-Ljbffr

This is a public notice flyer to notify interested applicants of anticipated vacancies. Applications will not be accepted through this flyer. Interested applicants must follow the directions in the "How to Apply" section of this flyer to be considered. There may or may not be actual vacancies filled from this flyer. Notice of Result letters will not be sent to applicants who respond to this flyer. Duties Help You will plan, develop, organize, administer, evaluate, and manage a comprehensive contract quality assurance program for conforming contractor quality systems conformance to contract requirements. You will identify and provide contractor availability, quality and management performance assessments to the contracting officer for use in determining future awards. You will review work specifications and other contract documents to ensure adequate quality requirements are specified. You will develop inspection system plans, instructions, and checklists to evaluate the effectiveness of the contractor's quality assurance programs. You will provide and input quality data into the appropriate quality assurance database. Requirements Help Conditions of employment Must be a US Citizen. Must be determined suitable for federal employment. Must participate in the direct deposit pay program. New employees to the Department of the Navy will be required to successfully pass the E-Verify employment verification check. To learn more about E-Verify, including your rights and responsibilities, visit e-verify.gov Within the Department of Defense (DoD), the appointment of retired military members within 180 days immediately following retirement date to a civilian position is subject to the provisions of 5 United States Code 3326. Males born after 12-31-59 must be registered for Selective Service. This is a bargaining unit position. You will be required to successfully complete a pre-appointment physical examination. You will be required to obtain and maintain an interim and/or final security clearance prior to entrance on duty. Failure to obtain and maintain the required level of clearance may result in the withdrawal of a job offer or removal. You will be required to obtain and maintain a current ISO 9000:2008 Internal Auditor certification. You will be required to wear personal protective equipment such as helmets, gloves, coveralls, glasses, goggles, respirators and safety shoes. This position may require travel from normal duty station to CONUS and OCONUS and may include remote or isolated sites. You must be able to travel on military and commercial aircraft for extended periods of time. This position requires work onboard ships. This position requires the ability to climb ladders. Qualifications GS-9: Your resume must also demonstrate at least one year of specialized experience at or equivalent to the GS-7 grade level or pay band in the Federal service or equivalent experience in the private or public sector. Specialized experience must demonstrate the following: Monitoring and evaluating contract quality assurance programs to ensure compliance with contract specifications for ship repair and overhaul. GS-7: Your resume must also demonstrate at least one year of specialized experience at or equivalent to the GS-5 grade level or pay band in the Federal service or equivalent experience in the private or public sector. Specialized experience must demonstrate the following: Providing assistance in monitoring contract quality assurance programs to ensure compliance with contract specifications for ship repair or overhaul. Additional qualification information can be found from the following Office of Personnel Management website: Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., professional, philanthropic, religious, spiritual, community, student, social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. Education In lieu of specialized experience, you may qualify with the following education or combination of both education and experience: GS-9: Successful completion of a master's degree or equivalent graduate degree with major study in quality assurance, statistics, mathematics, production management, industrial management, computer science, engineering, engineering technology, physical sciences, textiles, or another field related to the position. OR Successful completion of 2 full years of progressively higher level graduate education with major study in quality assurance, statistics, mathematics, production management, industrial management, computer science, engineering, engineering technology, physical sciences, textiles, or another field related to the position. OR Possession of an LL.B. or J.D. that is related to this position being filled. GS-7: Successful completion of 1 full year of graduate level education with major study in quality assurance, statistics, mathematics, production management, industrial management, computer science, engineering, engineering technology, physical sciences, textiles, or another field related to the position. OR A bachelor's degree with superior academic achievement with major study in quality assurance, statistics, mathematics, production management, industrial management, computer science, engineering, engineering technology, physical sciences, textiles, or another field related to the position. A transcript must be submitted with your application if qualifying using education. See Required Documents for additional information. Additional information This position is covered by the Department of Defense Priority Placement Program. Several vacancies may be filled. A tentative offer of employment will be rescinded if the selectee fails to meet the pre-employment requirements, including failure to report to any of the scheduled appointments. Federal annuitant information: The selection of an annuitant is subject to the Department of Defense and Department of the Navy policy on the employment of annuitants. Policy information may be found at: Veteran's preference does not apply when selecting individuals under this specific hiring authority. However, if you claim veteran's preference, you will be required to submit supporting documentation with your application as described in the Required Documents section below. Certain incentives (such as Recruitment, Relocation or Student Loan Repayment) may be authorized to eligible selectees. A relocation incentive is generally a single payment intended to offset some of the relocation costs experienced by the selectee. A relocation incentive may be authorized. Vacancies filled from this announcement may be filled at any grade level listed. If selected below the full performance level, you may be noncompetitively promoted to the next higher grade level after meeting all regulatory requirements, and upon the recommendation of management. Promotion is neither implied nor guaranteed. Expand Hide additional information Candidates should be committed to improving the efficiency of the Federal government, passionate about the ideals of our American republic, and committed to upholding the rule of law and the United States Constitution. Benefits Help A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new window Learn more about federal benefits. Review our benefits Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.

Introduction At Gallagher Bassett, we're there when it matters most because helping people through challenging moments is more than just our job, it's our purpose. Every day, we help clients navigate complexity, support recovery, and deliver outcomes that make a real difference in people's lives. It takes empathy, precision, and a strong sense of partnership-and that's exactly what you'll find here. We're a team of fast‑paced fixers, empathetic experts, and outcomes drivers-people who care deeply about doing the right thing and doing it well. Whether you're managing claims, supporting clients, or improving processes, you'll play a vital role in helping businesses and individuals move forward with confidence. Here, you'll be supported by a culture that values teamwork, encourages curiosity, and celebrates the impact of your work. Because when you're here, you're part of something bigger. You're part of a team that shows up, stands together, and leads with purpose. Overview Ideal candidates will have Lead or Supervisory experience in Workers' Compensation, jurisdictional knowledge and expertise preferred in California (CA), Oregon (OR), or New York (NY) (Northeast region). Open to all other jurisdictions. Remote 100%. How you'll make an impact Dedicated to offering exclusive customer care services to meet needs of client base, specializing in worker's compensation claims. Engineered customized client audits, monitor performance metrics, provide technical training, and assist branches in meeting client expectations. Development of processes and procedures to ensure compliance with client, broker, and carrier expectations. Oversight of resources and direct reports, development of trend analysis, producing/delivering training, and conducting both internal and external audits. Additional duties may include preparation of executive reports, monthly oversight reports, and review and development of processes of branch handling to improve claim outcomes. About You Ideal candidates for this position will have: 7-10 years experience working with Worker's Compensation claims. Previous auditing experience. Strong process management and leadership skills. Ability to professionally interact with all levels of claims management. Required Qualifications High School Diploma. Minimum of 7 years related Worker's Compensation claims experience. Knowledge of accepted industry standards and practices. Computer experience with related claims and business software. Desired Bachelor's Degree. Compensation and benefits We offer a competitive and comprehensive compensation package. The base salary range represents the anticipated low end and high end of the range for this position. The actual compensation will be influenced by a wide range of factors including, but not limited to previous experience, education, pay market/geography, complexity or scope, specialized skill set, lines of business/practice area, supply/demand, and scheduled hours. On top of a competitive salary, great teams and exciting career opportunities, we also offer a wide range of benefits. Below are the minimum core benefits you'll get, depending on your job level these benefits may improve: Medical/dental/vision plans, which start from day one! Life and accident insurance 401(K) and Roth options Tax‑advantaged accounts (HSA, FSA) Educational expense reimbursement Paid parental leave Other benefits include: Digital mental health services (Talkspace) Flexible work hours (availability varies by office and job function) Training programs Gallagher Thrive program - elevating your health through challenges, workshops and digital fitness programs for your overall wellbeing Charitable matching gift program And more… We value inclusion and diversity We value inclusion and diversity. Click Here to review our U.S. Eligibility Requirements. Inclusion and diversity (I&D) is a core part of our business, and it's embedded into the fabric of our organization. For more than 95 years, Gallagher has led with a commitment to sustainability and to support the communities where we live and work. Gallagher embraces our employees' diverse identities, experiences and talents, allowing us to better serve our clients and communities. We see inclusion as a conscious commitment and diversity as a vital strength. By embracing diversity in all its forms, we live out The Gallagher Way to its fullest. Gallagher believes that all persons are entitled to equal employment opportunity and prohibits any form of discrimination by its managers, employees, vendors or customers based on race, color, religion, creed, gender (including pregnancy status), sexual orientation, gender identity (which includes transgender and other gender non‑conforming individuals), gender expression, hair expression, marital status, parental status, age, national origin, ancestry, disability, medical condition, genetic information, veteran or military status, citizenship status, or any other characteristic protected (herein referred to as “protected characteristics”) by applicable federal, state, or local laws. Equal employment opportunity will be extended in all aspects of the employer‑employee relationship, including, but not limited to, recruitment, hiring, training, promotion, transfer, demotion, compensation, benefits, layoff, and termination. In addition, Gallagher will make reasonable accommodations to known physical or mental limitations of an otherwise qualified person with a disability, unless the accommodation would impose an undue hardship on the operation of our business. #J-18808-Ljbffr

Responsibilities Electronic Engineering/Quality Assurance Noblis MSD is seeking candidates for Electronic Engineering/Quality Assurance to support the Naval Information Warfare Center, Network Integration Engineering Facility (NIEF). The Associates will be responsible for the inspections and reviews of the various networks, programs, and communication systems for the NIEF. This includes but not limited to: the quality assurance and the quality control of all incoming, in process, and final delivery systems, to provide the highest level of quality products to our customers. The Associates will also develop and review reports and statuses for all quality related encounters. This is a full time / on-site position in San Diego, CA. Responsibilities: Responsible for the coordination and the completion of tasks assigned, and duties specific to the NIEF QA team. Read and understand engineering drawings for quality inspections. Maintain compliance with standards of the NIEF quality management system (QMS) for ISO 9001:2015 Assist in the initiation and resolution of quality inspections to include deviations, out of specification determinations and out of tolerance determinations. Uses configuration management tool (CMPro) for the generation, tracking, creation and closing of work orders. Inspect IUID labels and following the IUID requirements. Maintain a high level of quality awareness through on-the-job training and other required training. Responsible for the review, assessment, tracking, and follow-up, as well as the completion of quality inspections, investigations, CAPA, risk assessments, and other action items. Update databases as needed and provide and prepare weekly metrics to team lead. Identify and communicate trending and reoccurring issues and quality events to the team lead. Follow all applicable regulations, including ISO and company policies, procedures, and standards to provide the highest level of quality products. Required Qualifications Required Experience: Bachelor's Degree or Associate's Degree with 3+ years of experience or High School Diploma with 6+ years of experience Ability to obtain and maintain a Secret clearance. (Must obtain an Interim Secret clearance prior to start). 1-2 years of QA-related experience. Must be a US citizen. Required Skills: Basic knowledge and skill set for using mechanical tools. Must be able to lift up to 50 pounds. Desired Qualifications Active Secret clearance desired. Familiarity with C4l installation fields concepts, practices, and procedures. Familiarity with the defense communication system projects to include quality assurance, quality control, and risk management. Implementing good documentation practices (GDP). Ability to work independently with little supervision and in a team environment. Must have strong technical, interpersonal, written, and verbal communication skills. Must possess the ability to coordinate and collaborate with multiple functional areas in a government environment. Flexibility of schedule and the ability to work occasional overtime when necessary to meet on time deliveries. Be able to work effectively in a high paced environment. Flexibility to switch tasking focus when needed. Knowledge of current Naval or DOD installation processes, practices, and procedures Knowledge of mechanical and/ or electrical industry skillsets #nowhiring Overview Noblis and our wholly owned subsidiaries, Noblis ESI, and Noblis MSD tackle the nation's toughest problems and apply advanced solutions to our clients' most critical missions. We bring the best of scientific thought, management, and engineering expertise together in an environment of independence and objectivity to deliver enduring impact on federal missions. Noblis works with a wide range of government clients in the defense, intelligence and federal civil sectors. Learn more at Noblis -About Us Why work at a Noblis company? Our employees find greater meaning in their work and balance the other things in life that matter to them. Our people are our greatest asset. They are exceptionally skilled, knowledgeable, team-oriented, and mission-driven individuals who want to do work that matters and benefits the public. Noblis has won numerous workplace awards. Noblis maintains a drug-free workplace. *Remote/hybrid status is subject to change based on Noblis and/or government requirements Commitment to Non-Discrimination All qualified applicants will receive consideration for employment without regard to race, color, ethnicity, sex, age, national origin, religion, physical or mental disability, pregnancy/childbirth and related medical conditions, veteran or military status, or any other characteristics protected by applicable federal, state, or local law. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact us. EEO is the Law | E-Verify | Right to Work Total Rewards At Noblis we recognize and reward your contributions, provide you with growth opportunities, and support your total well-being. Our offerings include health, life, disability, financial, and retirement benefits, as well as paid leave, professional development, tuition assistance, and work-life programs. Our award programs acknowledge employees for exceptional performance and superior demonstration of our service standards. Full-time and part-time employees working at least 20 hours a week on a regular basis are eligible to participate in our benefit programs. Other offerings may be provided for employees not within this category. We encourage you to learn more about our total benefits by visiting the Benefits page on our Careers site. Salary at Noblis is determined by various factors, including but not limited to, the combination of education, certifications, knowledge, skills, competencies, and experience, internal and external equity, location, and clearance level, as well as contract-specific affordability and organizational requirements and applicable employment laws. The projected compensation range for this position is provided within the posting and are based on full time status. Part time staff receive a prorated salary based on regularly scheduled hours. The estimated minimum and maximum displayed represents the broadest range for this position (inclusive of high geographic and high clearance requirements), and is just one component of Noblis' total compensation package for employees. Posted Salary Range USD $65,200.00 - USD $101,950.00 /Yr.

Epsilon Systems Solutions, Inc. has a job opportunity for a Quality Assurance Specialist II in National City, CA. Summary: Directly reports to QA & EHS Director. Inspect and monitor work performed on government and commercial work items, specializing in Hull, Mechanical and Electrical Inspections for Quality compliance. Review work packages prior to start-work for completeness, accuracy and compliance with technical specifications and customer requirements. Non-Supervisory. Provide management oversight, and career development of production trades related to quality assurance and safety requirements. Provide Project QA inspections and assessments were requirements cannot be met by trade Quality Control Inspectors. Duties and Responsibilities: Establishes basic Test and Inspection Plans for projects. Perform in-process work surveillances, safety surveillances and conduct final work-package review after work-completion. Performs internal audit of to monitor compliance with company procedures and performs external audits to evaluate supplier suitability for use. Prepares Corrective Action Requests, and Preventative Action requests as related to production work to ensure compliance with established policies, procedures and work instructions. Assists Program Managers, Project Managers, and Supervisors/Foreman in the understanding of NAVSEA Standard Item and other customer related requirements to ensure work is conducted accurately and safely. Assists in the development of written procedures for Safety, Hull, Mechanical, and Electrical Trades work and tasks Monitors compliance with company Quality and Safety Management Systems, Workmanship standards and Customer requirements. Develops safety, quality control and inspection procedures for inclusion in test and inspection plans for production Work-Packages. Defines test standards and specifies test equipment associated with requirements established in test and inspection plans. Schedules and Conducts Safety/Quality Assurance inspections, Audit and Surveillances. Performs Audits and evaluations of Suppliers/Subcontractors. Works with customer QA/Safety representatives to coordinate inspection and acceptance activities. Reviews QA/Safety control requirements with customer representative to assure compliance with requirements. Reviews contractually required quality/safety documentation for accuracy and completeness for project/job/contract completion. Maintain OQE records retention. Performs other duties as assigned by the QA Manager Job Requirements: Bachelor's Degree and 2 years waterfront Quality Assurance experience to include NAVSEA Standard Item Compliance experience. Bachelor's Degree may be substituted with a completed Maritime Trade School / Apprenticeship with 3 years waterfront Quality Assurance experience OR 4 years' military service with specialized training and certifications in Quality Assurance to include NAVSEA Standard Item Compliance experience. Bachelor's Degree/Trade School/Military Service may be substituted with GED minimal education and specialized training and certifications in Quality Assurance with 5 years total waterfront experience with 3 years Quality Assurance experience to include NAVSEA Standard Item Compliance experience. Job Training : Safety, Quality Assurance and NAVSEA Standards for shipboard work. Certifications : Quality Assurance Inspector, Quality Assurance Auditor (preferred), NACE/NBPI (preferred), NDT Level II for VT, PT and MT (preferred), SYCP (preferred), OSHA required classes (521, 3115, 5410 and 3095) for NSI 009-08 Safety Representative (preferred), RCRA and DOT (Preferred). Base Access: Must be able to obtain and maintain access to U.S Military bases and shipyards for performance of job duties. Knowledge: Knowledgeable in shipyard, maritime, and commercial work practices, quality assurance, safety, Metal-work and contracting methods. Knowledge of Navy ship repair processes and procedures. Knowledge of OSHA Regulations for Shipyard Employment, NAVSEA Standard Items, Joint Fleet Maintenance Manual (JFMM), NAVSHIPS Tech Manuals (NSTM), Level I, and DOD Standards, Military Specifications, Performance Standards, and other customer related specifications and standards. Knowledgeable in all aspects of workplace Safety. Knowledge of the practical application of engineering science and technology. This includes applying principles, techniques, procedures, and equipment to the design and production of various goods and services. Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications. Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective fabrication or manufacture and distribution of products. Skills Able to conduct audits and surveillances. Able to develop trend reports based on results of the audits and surveillances. Able to conduct Job Hazardous Analysis specific for tasking Able to conduct tests and inspections of products, services, or processes to evaluate quality or performance. Effective written and oral communication skills. Able to use logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems. Effective interpersonal skills and able to lead/teach others. Effective problem solving skills. Provides sound judgment and decision. Proficient in Microsoft Office programs including but not limited to Word, Excel, Power Point and Access Abilities: Able to understand written sentences and paragraphs in work related documents in the English language. Able to read structural, mechanical and electrical drawings. Able to anticipate problem and apply general rules to specific problems to produce answers that make sense. Able to generate or use different sets of rules for combining or grouping things in different ways. Physical Requirements/Work Environment: Must be able to physically access ships, small craft, and submarines. Able operate in: confined Spaces, noisy environment, heavy Industrial conditions, high traffic areas, office environment, meetings and multiple locations. Able to Remain calm in: Stressful situations including; high pressure production schedule, strict workmanship requirements, customer interface, regulatory requirements. Able to lift, carry and move objects at least 25 lbs. in weight. Visual acuity and manual dexterity. Epsilon Systems Solutions, Inc. is an equal opportunity employer. Qualified candidates will be considered without regard to legally protected characteristics.

Description JOB DESCRIPTION/SUMMARY The CQC Manager will be assigned to Department of Defense (DoD) construction project(s) located in various regions. This individual will be responsible for all aspects of quality control (QC) and must be onsite during all phases of the construction work. While at the jobsite, the CQC Manager works with the customer and other contractor staff to ensure QC objectives are met in accordance with the contract requirements and high standards of service delivery are maintained. DUTIES AND RESPONSIBILITIES · Prepare and update the QC Plan.· Attend coordination meetings with the Client, subcontractors, and vendors.· Implement the “Three Phases of Control” for all definable features of work.· Perform inspections to ensure work is completed in compliance with contract requirements.· Stop work that does not comply with the contract plans and specifications and direct the removal and replacement of any defective work.· Prepare and submit daily quality control reports.· Conduct weekly QC meetings at the jobsite. • Oversee the review and approval of design and construction submittals.· Ensure As-Built drawings are updated daily.· Coordinate onsite and offsite testing. Maintain a testing log.· Review invoices prior to approval to ensure all relevant work has been completed in accordance with the contract requirements.· Perform punch-list and pre-final inspections.· Perform other duties as requested by supervisors and senior level managers in support of successful performance on all projects.MINIMUM QUALIFICATIONS, SKILLS, AND EDUCATIONAL REQUIREMENTS A Bachelor's of Science degree from an accredited school in engineering or sciences with a minimum of seven (7) years' experience (within the last ten (10) years), as a Superintendent, Project Manager, or Project Engineer and at least five (5) years field experience as a CQC Manager with repairs to DoD petroleum, oil, and lubricants (POL) facilities, tank rehabilitation, tank cleaning and repairs and emergency inspection Familiar with requirements of USACE EM-385-1-1, and experience in the areas of hazard identification, safety compliance, and sustainability Knowledge and experience with POL industry standards including API Std 650, API Std 653, API RP 2016, and API Std 2015 and procedures an applicable DoD criterion Completion of course entitled Construction Quality Management for Contractors must be completed prior to fieldwork INTER-PERSONAL RELATIONSHIPS Must work effectively with employees, subcontractors, and clients at all levels. WORKING CONDITIONS The position requires working at the construction job site for extended periods of time. The position may require working during weekends and extended hours in order to meet deadlines. We are committed to a merit-based hiring process that values individual skills, qualifications, and performance. Our hiring practices comply with all applicable federal, state, and executive orders, including the recent Executive Order on Equal Opportunity Hiring.

Full-time Description As a Construction Quality Control Manager (QCM), your construction expertise and excellent organizational skills will be crucial in ensuring our projects meet or surpass the Client's expectations. Working closely with the on-site team, you will actively schedule, plan, and manage technical activities to ensure accuracy and quality throughout the entire project. Your keen attention to detail will guarantee that all project documents, from start to finish, are accurate and complete. Company Culture At Smart Safety Group, we trust your skills and expertise. As a Construction Project Manager, you have the freedom to make decisions, explore new ideas, and grow professionally while adhering to our commitment to excellence. Teamwork is essential to us. You'll be part of a collaborative and supportive environment where we value the power of working together to achieve great results. We support your professional development at Smart Safety Group. We provide incentives to help you achieve your goals. If you're looking for opportunities to grow, Smart Safety Group offers room for advancement. Many of our key leaders started their careers in the field, showing that there are possibilities for you to progress within our organization. Key Responsibilities Create and execute a project-specific Quality Control Plan. Manage and maintain the QC software. Coordinate testing services and additional inspections as required by the contract. Understand and apply contract specifications accurately. Conduct weekly QC meetings. Complete all QC system documents such as daily reports and record drawing maintenance. Identify, document, track, and oversee the completion of re-work items. Communicate with the Client, subcontractors, and suppliers using various methods like meetings, emails, letters, and phone calls. Keep track of, prepare, review, and submit necessary documents on time to ensure accuracy. Conduct inspections before and after completing different parts of the work. Prepare and submit reports promptly. Carry out LEED coordinator duties, if applicable. Attend project meetings. Focus on site safety practices. What We Offer Health, dental, and vision insurance premiums 100% paid. Wages: $35 - $45 per hour Health Insurance Dental Insurance Vision Insurance Life Insurance 401(k) with 100% match up to 6% of salary Paid time off Professional development assistance Schedule This position may rotate between project work groups that operate under different California-approved schedules. Some work groups follow an Alternative Workweek Schedule of four 10-hour days (4/10), while others operate on a five 8-hour day schedule. Placement into a work group determines the schedule. If a change in work group results in a schedule change, the company will provide notice consistent with California labor regulations and company policy. Full time Hours vary, weekend work may be required. On-site where the project is located. Must be willing to travel. Requirements Qualifications & Experience At least 5 years' construction experience Experience in both civil and building construction. Strong communication skills (both written and verbal) Ability to pass a background check to gain access to work on military bases. Current QC certification with Army Corps of Engineers or Navy (Construction Quality Management for Contractors - CQMC) strongly preferred. B.S. degree in construction management, engineering, or related field preferred Experience with federal or public works construction projects is preferred. Technical Skills Proficient in Excel, Word, Outlook, Teams, etc. Experience with Primavera P6, RMS, Oracle, etc. is preferred. Salary Description $35-$45/hr.

Quality Control Manager- Camp PendletonCompetitive Salary and EMPLOYER PAID INSURANCE! EMI Services is hiring a Quality Control Manager (QCM) to work directly with the project manager, the operations manager, the safety supervisor, as well as the United States Government. This position assures quality services to customers: reports performance levels and degrees of compliance with an established QC program. The QCM is required to test and inspect services and work performed for compliance with contract requirements and performance standards. Evaluate data and write reports to validate or indicate deviations. Recommend modifications or necessary actions to achieve optimum quality. Monitor building conditions for possible QC issues or violations, in conjunction with the Safety Supervisor. Also, monitor work assignments and projects for safety or health issues. In addition, the QCM produces and analyzes reports and makes recommendations for quality improvements, as well as, investigates complaints and report's findings to the project manager. The ideal EMI Quality Control Manager promotes quality and customer services excellence. Salary Starting at $100,000 (DOE) plus employer paid insurance! Key Responsibilities Work closely with Project Manager, FSM, SSHO, subcontractors and QCI Staff ALL aspects Quality Control Inspection and documentation of Service and Maintenance work Develop and maintain quality surveillance and tracking system for maintenance shops and subcontractors Develop and implement QC plan, ensuring environmental plan compliance, performance monitoring, analysis and reporting Advise the Project Manager on quality control and environmental program status, strategies, issues and potential problem areas Monitor and track specialized qualifications or credentials such as licenses, certificates, degrees or training needed by personnel Enforce all regulatory, base and company specific safety rules Manage Quality Control Inspectors Lead monthly QCM with Government Execute additional duties and responsibilities as assigned and/or required to complete the project Essential Skills Effective oral and written communication skills Strong organizational, interpersonal skills Type; operate a personal computer, with emphasis on accuracy, mental alertness, and neatness Demonstrated ability to work accurately, follow procedures and schedules, and prioritize multiple tasks Ability to read and understand blueprints, specifications, and contract requirements Proficiency with all MS Office products (Word, Excel, Access, PowerPoint) Ability to work successfully in a team environment, aligning with company culture and processes Must possess a strong work ethic and values that are above-reproach Understand and adhere to policies and procedures as set by EMI Services Promote and maintain a positive image of EMI Services Maintain confidentiality of information related to EMI Services, our customers, vendors and employees Be adaptable and flexible in work situations. Establish priorities to ensure completion of tasks in a timely manner Inform the Project Manager of all pertinent problems, irregularities, and other important information within area of responsibility Adhere to safety policies and procedures to include proper use of personal protective equipment Requirements High School Diploma or equivalent 5 + years of experience as a Quality Control Manager working federal projects Experience with Government Contracts and Personnel ASQ CMQ/OE Certification Safety Certification OSHA 30 hour Construction Quality Management course within 5 years Valid driver's license compliant with REAL ID Act or are you willing and able to obtain one Pass a pre-employment drug screening and background check Regular, dependable attendance required U.S. citizenship to obtain and maintain access to military installations *This individual is subject to Government approval Preferred Qualifications Bachelor's degree or equivalent experience (1:2 ratio) with maintenance and repair facilities Physical Requirements Carrying objects/boxes/print-outs short distances Extensive work with a personal computer Lifting and moving as much as 50 pounds with assistance Use of hands, reaching with hands and arms, talking, and walking Prolonged periods of sitting, bending, squatting, standing, twisting, or stooping Climbing ladders and entering confined spaces Work both indoors and outdoors in various temperatures (some extreme) and weather conditions *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 accommodations may be made to enable individuals with disabilities to perform the essential functions. Click here to follow EMI Services on Facebook Benefits Health Care Plan (Medical, Dental & Vision) Retirement Plan (401k, IRA) Life Insurance (Basic, Voluntary & AD&D) Paid Time Off (Vacation, Sick & Public Holidays) Employee Stock Ownership Plan (ESOP) Short Term and Long Term Disability Term Life Insurance What We Do EMI is an industry-leading provider of DoD base operation support services, facilities maintenance, and logistics. Our goal is to contribute to the repair and maintenance of buildings and equipment. EMI consistently delivers cost-saving through best-value innovations and quality service that exceeds our clients' expectations. What Sets Us Apart The Right Partner: EMI has grown by gaining our customers' trust and our employees' loyalty. We've successfully performed over 60 service contracts and we understand the unique challenges facing today's military. We offer exceptional responsiveness and a strong commitment to customer satisfaction. We demonstrate this commitment by consistently earning some of the highest customer satisfaction ratings in the industry. The Right Team: The EMI team includes over 250 high-achieving professionals, administrative and trades personnel deployed in various locations throughout the United States. At times, we augment our in-house capabilities with proven and capable business partners. The Right Approach: EMI brings vast expertise and proven solutions to augment our clients' operations. We provide a platform that delivers seamless mission support and exceptional customer service in a very cost-effective and repeatable solution. #emiservices

As a Senior Quality Control Manager, you will ensure the project is built within contract document specifications, owner requirements, and comply with local, state, and federal building codes. You will coordinate with other trades, process daily reports of project progress and adhere to all guidelines issued by the owner. As a strong communicator, you will help to build a quality control team that is open, transparent, and delivers excellence. **Responsibilities** + Partner with the project team to understand, plan, and implement the contract drawings and specifications + Collaborate with the owner, design team, and contractors to ensure quality and timeliness of project construction and completion + Implement and manage the "Three Phases of Control" Quality Control Plan + Oversee submittal review and approval + Schedule and conduct quality control meetings - Preparatory, Initial Phase, Follow-up + Control documents related to quality control functions + Establish testing procedures in accordance with contract specifications + Manage inspections process + Coordinate third party testing agents and interface with the Owner's representatives as required + Closely track and maintain a project deficiency log + Manage the punch list process + Oversee project closeout deliverable process-training, O&Ms + Confer directly with the executive management team + Encourage, lead, and/or participate in staff training and development + Proactively identify and develop relationships with industry professionals to generate and win the right work + Take an active role in recruiting top industry talent to join the Clark team. Identify, hire, and retain outstanding people + Exceed our stakeholders' expectations by anticipating their needs, desires, and goals **Basic Qualifications** + Undergraduate degree in a construction or related discipline or relevant experience + Minimum 8-10+ years verifiable construction quality control and/or inspection experience + Experience within building / commercial construction + Takes initiative and personal responsibility to always deliver value and excellence + Uses expertise to create a vision and aligns the team to deliver/achieve desired outcomes + A track record of establishing/contributing to creative strategic solutions + Ability to communicate effectively with, persuade, and gain "buy-in" from, a broad range of stakeholders (e.g., executive team, leadership team, Business Unit Leaders, direct reports, clients, trade partners, and third party providers + Alignment to Clark Standards of Excellence: self-motivated, results oriented, adaptable, team player, accountable, ethical, innovative, resilient, builds relationships, builds people/teams and followership, sets direction and executes **Preferred Qualifications** + Experience in large scale construction management or construction trade with increasing levels of responsibility + Must be able to manage other inspectors and submittal clerks, as well as coordinate independent material testing and lab work + Ability to process a large volume of submittals / RFIs + Prior experience developing and managing Quality Control Plans The work environment and requirements described below are representative of those necessary for an employee to successfully perform the essential functions of this role. **The Physical Side of the Role:** This is an active, hands-on role. You can expect to be on your feet frequently, navigating active job sites with uneven terrain, stairs, ladders, and hoists. The work is physically demanding and requires a full range of motion, including bending, kneeling, and reaching. You'll need to be comfortable frequently lifting and carrying materials up to 25 pounds, and occasionally up to 50 pounds. This role requires the ability to communicate effectively, as well as visual acuity for reading plans and inspecting work. The role does include desk time in the office that may require prolonged periods of sitting for tasks like computer work, document review, and meetings. **Your Work Environment:** You'll spend a significant amount of your time on active construction sites, which means being adaptable to all kinds of weather and moderate to loud noise levels, and comfortable in elevated or confined work areas with moving mechanical equipment and with the fast-paced nature of a project in progress. You will also spend time in a typical office setting with moderate noise levels. Your safety is our top priority, and you'll be expected to follow Clark Construction's safety policies and procedures, and all applicable laws, at all locations. **Our High-Performing Culture:** This is a demanding, high-performance environment. We are looking for candidates who are energized by challenge, thrive under pressure, and are prepared to do what it takes to achieve exceptional results. Success in this role requires significant commitment, including flexibility to work extended hours, especially during critical project phases or client deadlines. Beyond regular working hours, there will be occasions where business needs require your attention, particularly for time-sensitive matters or emergencies. You are expected to monitor and respond to communications (phone calls, emails, text messages) as required to address these situations effectively. Your ability to manage these expectations and be responsive when critical issues arise is key to your success in this role and our collective success as a team. **A Drug Free Workplace:** Clark promotes a drug free workplace. A pre-employment drug "fitness for duty" screening is required, and the company conducts random quarterly drug "fitness for duty" tests. _Clark offers a total compensation package that includes base salary, bonus potential, and a comprehensive benefits package including health/dental/vision benefits, paid time off, retirement/401k, and Company Contribution plan. Additional benefits include life insurance, commuter benefit, short & long term disability, fitness reimbursement, FSA, tuition reimbursement, back-up daycare, tutoring & family support benefits, EAP/Work-Life assistance, and a holiday contribution program. For this role the base salary range i_ _s_ _$110,000-220,000._ _Compensation may vary_ _outside of this range_ _depending on a number of factors, including a candidate's education, experience, skills, and geographic location. Base pay is one part of the Total Compensation Package that is provided to compensate and recognize employees for their work._ _*********************************************************** \#LI-KS1 Clark Construction Group is one of the largest building and infrastructure companies in the United States. Our portfolio spans every major building market, from public to private, corporate to cultural, education to entertainment, and the infrastructure connecting it all - power, transportation, water, and roadways. Since 1906, we've been delighting and delivering value to our clients and project partners, providing diverse opportunities for our team, and strengthening the communities where we live. With offices strategically located across the country, we pride ourselves on being a local builder with national reach. Learn more about Clark Construction (*********************************** . There is a sense of camaraderie that comes with delivering impactful projects as a team. It creates a sense of humility and fosters pride in the work we do. At Clark, we are proud to build what matters, together. Learn more about careers at Clark (****************************************** . Find even more opportunities with the Clark Group, our collection of companies - delivering construction and asset solutions for clients across the United States. Clark Group's capabilities span the entire asset lifecycle - from project development and financing to construction and facility maintenance. **_Asset Solutions_** **Altura Associates (********************************************* **Coda** **Edgemoor Infrastructure & Real Estate (************************************************ **S2N Technology Group** _Building & Infrastructure_ **Atkinson Construction (*********************************************** **Shirley Contracting Company** **C3M Power Systems (************************************************** **_Equal Opportunity Employer_** Clark Construction Group, LLC (and its subsidiaries and affiliates) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, age, national origin, religion, physical and mental disability, genetic information, marital status, sexual orientation, gender identity, citizenship, pregnancy or maternity, protected veteran status, or any other status prohibited by applicable national, federal, state or local law. Clark promotes a drug-free workplace. Applicants have rights under Federal Employment Laws: Family and Medical Leave Act (FMLA), Equal Employment Opportunity (EEO), and Employee Polygraph Protection Act (EPPA). Clark is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please email ************************************ or call ************** and let us know the nature of your request and your contact information. **_Authorization to Work_** Applicants must be currently authorized to work in the US on a full-time basis in order to be considered. Equal Opportunity Employer: Clark Construction Group, LLC, (subsidiaries and affiliates) is an Equal Opportunity Employer committed to diversity and inclusion in the workplace. All qualified applicants will receive consideration for employment without regard to sex, race, color, age, national origin, religion, physical and mental disability, genetic information, marital status, sexual orientation, gender identity/assignment, citizenship, pregnancy or maternity, protected veteran status, or any other status prohibited by applicable national, federal, state or local law. Clark Construction promotes a drug-free workplace.

Since 1996, RQC, LLC. has been a leading player in Southern California's robust commercial and governmental Design-Build economy. Headquartered in beautiful Carlsbad, CA, we are a full-service Design-Build company. We offer management of projects throughout the United States, with our field operations' team members who work on location for each of our projects. We specialize in fast-track projects in new commercial construction for both public and private clients, with a primary focus in the Department of Defense market. We are looking for Construction Quality Control Manager candidates to join our West Coast Field Operations team for military/federal projects located in San Diego County. Headquarter/Office assignment will be in Carlsbad, but specific construction project could be anywhere in San Diego County. QC Manager's are responsible for planning, coordinating, and implementing a project-specific quality control program, executing its performance according to contract requirements, completing administrative documentation on time, and cultivating customer satisfaction with the client, all in alignment with RQ's Mission, Vision, and Values. Local candidates will be given preference depending on location of project, though relocation or travel to on-site management will be required for the QC Manager position. The QC Manager position must work on-site. Pay: $100,000-$145,000 annually (depends on experience) Fringe Benefits: Vehicle Allowance, Medical/Dental/Vision Benefits (UnitedHealthcare), Vacation/Sick/Holiday Pay, Bonus eligibility Ideal Candidates will have the following experience: * A graduate of a four year accredited college or university program within the discipline of Engineering, Architecture, Construction Management, Building Construction, or Building Science. A combination of equivalent work experience and training in the field may be qualifying. * A minimum 5 to 10 years' experience as a Project Manager, Superintendent, QC Manager, Project Engineer, or Construction Manager with at least two years of continuous experience as a QC Manager required. * A current USACE CQM for Contractors Certificate (or equivalent) is required. * Specialty inspection training and licenses/certs highly desired. * LEED AP, AP+ or Green Associate (GA) Certificate preferred. * Level 1 EM 385-1-1, CRP, First Aid, OSHA 30-hour certifications required. Training can be provided. * Computer literacy (Microsoft Office, Outlook, Internet, etc.) required. * Specific software literacy (Viewpoint/Vista) preferred. COMPANY PROFILE: RQC, LLC is a full service contracting and design firm that specializes in Design/Build projects for both public and private clients, with a primary focus on the Department of Defense. Our mission is "to provide our customers the best built environment while being the first choice of all stakeholders." We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, creed, gender (including gender identity and gender expression), religion (all aspects of religious beliefs, observance or practice, including religious dress or grooming practices) marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition (including cancer or a record or history of cancer, and genetic characteristics), sex (including pregnancy, childbirth, breastfeeding or related medical condition), genetic information, sexual orientation, veteran status, or any other basis or status protected by federal, state, or local law or ordinance or regulation. All candidates considered for hire must provide evidence of identity and U.S. work authorization at the time of hire. Additionally, all candidates must successfully pass a drug screening and commercial criminal background check, including a stricter Department of Defense background check, for access to job site at military base (if applicable for position being hired for).

Cirsium Biosciences is creating the next generation of manufacturing technologies for viral vector production. Our novel plant-based platform solves the existing problems of speed, flexibility, scalability, and safety in viral vector manufacturing while dramatically reducing production costs. Our goal is to enable global and equitable access to life-changing genetic therapies. Position Overview We are seeking a highly collaborative Director, Quality Assurance to join and lead the QA function for our growing organization. This strategic role will oversee all aspects of Quality, including the development, implementation, and management of GxP (cGMP, GCP, and GLP) quality systems. Our ideal candidate should have a strong knowledge of relevant regulations and be able to manage and work cross‑functionally to ensure compliance of Cirsium's ongoing development programs with local, state and federal requirements. This position will support developing a culture of quality, ensuring compliance with regulatory requirements, driving continuous improvement in quality systems, supporting the successful development, manufacturing, and commercialization of our unique products. Key responsibilities Assist with developing, implementing, and maintaining GxP compliant quality systems and processes to ensure compliance with FDA, EMA, ICH, and global competent authority regulations and industry guidance Co- lead quality audits, risk assessments, and investigations, ensuring timely resolution of quality issues. Work with the company's external suppliers and contract organizations to ensure consistent quality and compliance. Prepare for and manage inspections by regulatory agencies and commercial partners, serving as a liaison between the Company and auditors, including reporting and follow-up to any finding Work on qualification and validation plans, assure proper batch releases and disposition. Oversee resolution of any product concerns, including investigation, tracking and corrective action plans (CAPA). Provide quality input on contracts and serve as a point person for negotiations of quality agreements. Champion a culture of quality and continuous improvement across manufacturing and development operations. Qualifications Bachelor's degree in biological sciences or related field, with a minimum of 7 or more years experience in Quality Assurance or related fields within the pharmaceutical or biotechnology industry Extensive knowledge of GxP (GMP, GLP, and GCP) regulations and guidelines, including FDA, EMA, and ICH requirements Demonstrated hands‑on experience working on complex projects. In‑depth knowledge of FDA, EMA, and ICH guidelines, regulations, and processes related to CMC. Strong partnering and communication skills required, as well as project management skills. Must be focused on working collaboratively and within our values of: Data rules, All‑in, Own it (Accountable), Caring and Humble. Ability to work effectively in a collaborative, fast‑paced environment. Strong analytical skills, excellent problem‑solving skills, and innovative thinking for sustainable practices. Strong organizational and time‑management skills with the ability to handle multiple projects. Excellent leadership and communication skills, and the ability to work in a collaborative, fast‑paced environment. Generous PTO Health Insurance & Health Savings Account Vision Insurance Employee Assistance Program (EAP) Stock Options Professional Development Opportunities 401(k) Plan Life & AD&D Insurance And More... Cirsium Biosciences is an emerging company located in San Diego, California. We offer highly competitive compensation and employee programs, including comprehensive health, dental and vision plans, generous time off, and equity in our early‑stage company. We are dedicated to fostering a workplace that keeps our team inspired and engaged. We offer an inclusive company culture where employees feel respected and valued. Cirsium Biosciences is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation, veteran status, or any other protected categories. #J-18808-Ljbffr

A leading medical technology company seeks a Quality Systems and Regulatory Staff Lead in San Diego, CA. This role involves managing post-market quality processes, ensuring compliance with regulatory standards, and collaborating across teams to enhance quality systems. The ideal candidate will have extensive experience in quality assurance and risk management within the medical device sector, with a focus on FDA interactions and regulatory communications. Join us to be part of an innovative team committed to advancing health technology. #J-18808-Ljbffr