Compliance QA Manager - Systems
Quality manager job in Alameda, CA
The Compliance QA Manager - Systems is responsible for the oversight, support, and administration of client's Quality Management Systems (QMS) to ensure these are effective and efficient, and maintained to support GxP functions. Supports end users and QA requirements, account management, and evaluates changes for implementation and continuous improvement initiatives.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
As QA Core, supports QA Partner:
· Analyze user enhancement requests to deliver solutions focused on establishing and improving business processes that improve efficiency, address process gaps, and enable automation and growth of the organization.
· Gather and document user and functional requirements
· Participate in the authoring and execution of implementation plans, development of solutions and manage project/change timelines
· Perform User Acceptance testing (UAT), Performance Qualification (PQ) and Validation testing, if applicable
Day to day business system administration:
· Manage system access and permissions
· Perform change management activities
· Design solutions and manage configuration
· Liaise with users to resolve issues
· Create reports based on defined requirements
· Maintain system documentation
· Create and run reports; track follow-up actions to ensure data quality and compliance
· Reviews and approves validation deliverables (URS, FS, IQ/OQ/PQ, etc.)
· Identifies, mitigates, escalates, and resolves issues and risks
· Authors and review CSV, DI policies, procedures, lifecycle documents
· Help generate metrics to support business goals
· Maintain end-user support information
· Manage updates to business guidance and user reference documentation
· Continuously look for ways to improve monitoring, user issues and deliver better value to the customer
· Support activities related to internal and external audits/inspections
· Support activities related to Computer System Validation and Data Integrity program.
· Oversee and maintain the Integration tool with the Leaning Management System, ComplianceWire, if applicable
SUPERVISORY RESPONSIBILITIES:
· None
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
· Bachelor's degree in science or related field and a minimum of 7 years of related experience; or,
· Equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job:
· At least 5 years of experience working on validated applications in a pharmaceutical or regulated environment.
· Experience and knowledge of the quality and regulatory business processes.
· Direct hands-on experience implementing GxP computerized systems and maintaining validated state.
· Strong process improvement skills and orientation.
· Must have proven business and technology skills with success providing customer- oriented technology solutions environment.
· Proven strong communication skills interacting with user and technical communities.
· Ability to communicate ideas in both technical and user-friendly language.
· Collaborative working approach.
Knowledge/Skills:
· General knowledge of System Administration with the Veeva Platform (Quality QMS, Quality QDocs)
· Working knowledge/experience with Other Regulated Applications, such as Learning Management Systems and Quality Management Systems.
· General knowledge of database and computer networking
· Working knowledge/experience with SaaS systems
WORKING CONDITIONS:
Environment: primarily working indoors, performing office work.
Desired Skills and Experience
Roth Staffing is looking for a Compliance QA Manager
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.
Air Quality Engineer/Scientist - Mid to Senior Level (Environmental Compliance Specialist)
Quality manager job in Berkeley, CA
Join Yorke Engineering, LLC, an Environmental Consulting leader in California that implements Environmental Engineering and Compliance solutions for our clients throughout California. Our mission is to solve environmental compliance problems for industrial and governmental/infrastructure facilities. We are a growing and dynamic organization of highly respected professionals. Yorke Engineering, LLC has assisted over 1,400 client organizations with their Air Quality and Environmental Compliance, Engineering, and Permitting needs. Our philosophy is to efficiently help government and industrial customers with the complex array of environmental laws and regulations. From simple permits to complex agency negotiations, from small companies to the largest of California's organizations, Yorke successfully solves our clients' Air Quality and Environmental challenges. Our team has over 1,000 years of combined environmental experience and consists of engineers and scientists that specialize in Air Quality, Waste, Water, CEQA, Safety, and Industrial Hygiene.
We are looking for a sharp Mid to Senior level Air Quality Engineer/Scientist (Environmental Permitting and Compliance) to join our team in Northern CA. This is a full-time position at 40 hours per week from one of our Northern CA offices (Berkeley, San Francisco, or San Jose) during our normal business hours. We offer competitive salaries, a full benefits package including Paid Time Off, Holidays, Full Medical/Dental/Vision, along with a 401k program with a generous company match.
Position Summary:
The Mid to Senior level Air Quality Engineer/Scientist (Environmental Permitting and Compliance) performs professional engineering work, leading and executing the compliance and permitting functions in relation to Air Quality Regulations and Compliance. This candidate will be reviewing processes and equipment, analyzing permit-related technical and regulatory issues, and communicating those analyses within Yorke, the client organization, with government agencies and with the public at large. The work is challenging, broad in scope, and variable from project to project. The position involves effective communication, decision-making, and time management. The candidate performs other duties as required or assigned.
The candidate's experience and qualifications we are seeking include:
5-15+ years of work experience in the Air Quality and/or Environmental industry in an engineering role (preferably in a consulting environment);
Experience in the environmental services industry focusing on Air Quality services:
Process and equipment review;
Air quality permitting under BAAQMD, SCAQMD, SJVAPCD and other Air Districts, including Title V Permitting;
RECLAIM implementation and reporting;
Annual Emissions Reporting;
Air Dispersion Modeling;
Air Quality Assessments including Data Analysis and Emission Inventories;
General Air Quality Compliance for facilities in CA.
Ability to be an active team member on project teams towards project completion within project scope, budget and schedule and ensure quality work product and deliverables;
Ability to work with clients, staff, and regulators through effective communication and expertise by fostering a collaborative environment without losing focus of quality;
Proven track record or desire to engage in successful regulatory work in dealing with the SCAQMD, BAAQMD, SJVAPCD, EPA, CARB and/or other similar regulatory agencies;
Experience or desire to work on-site at client facilities;
Prepare reports and submissions in timely manner;
Experience with handling highly technical data and technical data interpretation;
Highly motivated to continue working in Air Quality environmental field and expand their knowledge and experience;
CA Regulatory/Compliance experience is required.
Job Requirements:
B.S or M.S. degree in Chemical Engineering, Environmental Engineering, or Mechanical Engineering, or other relevant technical degrees from an accredited college (minimum GPA of 3.0);
Ability to work collaboratively in a team fashion, handle several projects at once, prioritize work, and work efficiently;
Desire to learn or developing technical expertise in environmental rules and regulations;
Excellent oral and written communications skills;
Experience in conflict resolution and crisis management;
Track record of successful analysis, interpretation, and application of rules and regulations towards practical solutions;
Ability to think critically and develop solutions;
Software Knowledge:
Strong Microsoft Excel, Word, Outlook, and Powerpoint skills (required);
Microsoft 365 Applications, including Sharepoint (a plus)
EIT, CPP or P.E. Certification (a plus).
Director of Quality Mission Assurance
Quality manager job in Alameda, CA
Details: We're seeking a Director of Quality and Mission Assurance to lead reliability, safety, and risk management for an advanced space hardware manufacturer. This executive-level position oversees all quality operations and ensures mission success from design through delivery.The ideal candidate brings deep experience in aerospace quality standards, mission assurance leadership, and the ability to build systems that guarantee product reliability under the most demanding conditions.Key Responsibilities
Establish and lead the company's Mission Assurance strategy and framework
Manage risk identification, mitigation, and mission-critical tracking across programs
Oversee Design Assurance and System Safety programs from concept to flight
Lead the Failure Review Board (FRB) and ensure thorough root cause analysis
Implement and maintain a comprehensive Quality Management System (QMS)
Drive AS9100 certification and compliance with space industry standards
Lead supplier quality programs, audits, and technical reviews
Oversee manufacturing quality processes, MRB management, and non-conformance control
Foster a continuous improvement culture using Lean and Six Sigma tools
Build, mentor, and scale a high-performing quality and mission assurance team
Details: Education & Experience
Bachelor's degree in Engineering, Physical Sciences, or a related technical field
10+ years of experience in aerospace, defense, or space system quality and assurance
Proven success implementing QMS and leading quality operations in a startup or growth environment
In-depth knowledge of AS9100, NASA, and DoD quality and mission assurance standards
Preferred Qualifications
Master's degree in a technical discipline
Certifications: CQE, CMQ/OE, or equivalent
NADCAP accreditation experience (special processes)
Experience with reliability engineering, risk analysis, and system safety programs
Strong customer-facing and cross-functional leadership experience
Ability to blend strategic vision with hands-on problem solving
Salary - $212,500 - $261,800
Director of Quality Mission Assurance
Quality manager job in Alameda, CA
We're seeking a Director of Quality and Mission Assurance to lead reliability, safety, and risk management for an advanced space hardware manufacturer. This executive-level position oversees all quality operations and ensures mission success from design through delivery.The ideal candidate brings deep experience in aerospace quality standards, mission assurance leadership, and the ability to build systems that guarantee product reliability under the most demanding conditions.Key Responsibilities
Establish and lead the company's Mission Assurance strategy and framework
Manage risk identification, mitigation, and mission-critical tracking across programs
Oversee Design Assurance and System Safety programs from concept to flight
Lead the Failure Review Board (FRB) and ensure thorough root cause analysis
Implement and maintain a comprehensive Quality Management System (QMS)
Drive AS9100 certification and compliance with space industry standards
Lead supplier quality programs, audits, and technical reviews
Oversee manufacturing quality processes, MRB management, and non-conformance control
Foster a continuous improvement culture using Lean and Six Sigma tools
Build, mentor, and scale a high-performing quality and mission assurance team
Director, GCP Quality Assurance
Quality manager job in South San Francisco, CA
Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company's Native Complex Platform™ recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular context. This approach enables novel access to modern structural and screening technologies used in industrial-scale drug discovery for the entire class of GPCRs. Septerna has an emerging pipeline of GPCR-targeted small molecule programs with potential for growth to target many GPCRs that have been undruggable and unexploited to date.
We are excited to expand our multidisciplinary team of individuals focused on creating revolutionary medicines to address the unmet needs of patients. At Septerna we strive to embrace diversity of thought, expertise, and background through collaboration. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission. We share a fearless pursuit of ground-breaking innovations and cultivate an environment where our employees succeed by learning from each other and working as a team.
We are committed to the development of meaningful therapeutics for patients with indications of high unmet need. This is a tremendous opportunity to work with talented individuals on the frontlines of therapeutic discovery and development. You will directly help move therapies through preclinical research, positioning them for success in the clinic. The successful candidate will add their passion, unique talents, and expertise to a dynamic team motivated to discover new disease-modifying therapeutics for patients in a fast-paced environment.
For more information see: *****************
THE ROLE
We are seeking an experienced, dynamic, and results-driven Associate Director / Director of GCP Quality Assurance our on-site team in South San Francisco. This role is critical in providing both strategic and operational quality oversight of clinical studies and vendor programs, ensuring compliance with ICH GCP and global regulatory requirements, and upholding our high standards for data integrity. The ideal candidate will collaborate closely with clinical study teams and cross-functional partners, fostering a culture of quality and maintaining a state of continual GCP compliance across all programs.
Responsibilities:
Provide quality oversight and GCP guidance to clinical study teams and CROs/vendors to ensure compliance with ICH GCP, applicable regulatory requirements, and Septerna standards.
Ensure clinical trials are conducted in accordance with GCP principles, producing high-quality and reliable data.
Evaluate clinical trial documentation, study processes, and operational plans to confirm alignment with Septerna expectations and applicable regulations.
Interpret and apply clinical and regulatory compliance requirements to support Septerna's objectives and ensure effective implementation across programs.
Collaborate with clinical study teams to provide vendor quality oversight, identify and assess risks, and recommend appropriate remediation actions.
Develop and execute GCP audit plans for assigned clinical studies as part of ongoing quality oversight.
Partner with clinical functions to provide quality guidance and drive the implementation of fit-for-purpose procedures that ensure data and documentation are generated and managed in compliance with GCP.
Work with cross-functional teams to assess and manage risks associated with vendors, supporting study compliance, data integrity, and participant safety.
Assist in periodic reporting of key quality metrics to leadership to support continuous improvement in GCP compliance across Septerna.
Promote a culture of quality through effective communication, training, and proactive engagement with internal and external stakeholders.
Qualifications
Bachelor's degree in life sciences or a related field; an advanced degree is preferred.
8-10 years of professional experience in Quality Assurance within the biopharmaceutical industry, with progressive responsibilities in Clinical QA.
Minimum of 6 years of direct GCP audit experience, including investigator sites, CROs, and other clinical vendors.
Proven ability to evaluate the effectiveness of CAPAs and follow up on audit findings to ensure timely and complete resolution.
Strong knowledge of ICH GCP and applicable global regulatory requirements governing clinical research.
Demonstrated experience providing GCP oversight of clinical studies and vendor programs.
Skilled in authoring and revising SOPs, implementing process improvements, and ensuring quality systems remain phase-appropriate and fit-for-purpose.
Demonstrated ability to assess compliance risks, interpret regulations, and implement practical, risk-based quality solutions.
Excellent collaboration and communication skills with the ability to work effectively across functional areas and external partners.
Highly organized and detail-oriented, with the ability to manage multiple priorities in a fast-paced, evolving environment.
The anticipated salary range for candidates who will work in South San Francisco, CA is $220,000 - $240,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.
Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.
We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Septerna participates in the E-Verify program.
California Consumer Privacy Act Privacy Notice For Job Applicants. If you are a California resident, click here for our CCPA Notice.
Auto-ApplyDirector of Quality Assurance
Quality manager job in South San Francisco, CA
About Zenflow Zenflow, Inc. is a privately held medical device company dedicated to improving treatment for patients suffering from urinary obstruction caused by enlarged prostate. The innovative Spring technology was designed with the patient experience in mind and relies on a small spring-like coil that gently props open the urethra, restoring its normal function while preserving the natural anatomy. The Zenflow Spring System is an investigational device and is not approved for commercial sale.
POSITION OVERVIEW:
The Director of Quality Assurance provides strategic direction, management, and alignment of quality functions to ensure overall compliance with applicable national and international regulations, standards and best practice including FDA QSR, ISO 13485, and EU MDD.
MAJOR DUTIES AND RESPONSIBILITIES:
* Serves as Management Representative
* Hosts FDA and regulatory agencies' quality system audits
* Sets up Quality System policies and procedures to ensure compliance with FDA QSR, ISO 13485, and EU MDD requirements
* Routinely evaluates the existing quality system to identify opportunities to streamline processes, and to ensure compliance with FDA QSR, ISO 13845, and MDD
* Writes quality objectives
* Manages quality resources, including personnel, equipment and budget in alignment with departmental and corporate goals
* Performs Management Reviews and advise management of any product or process related issues and makes recommendations for improvements.
* Plans and manages internal audit activities and coordinates audit corrective actions
* Manages the quality group to ensure effective development and implementation of the Quality System Processes
* Performs other duties as assigned
EDUCATION REQUIREMENTS: Requires BS in a scientific or engineering discipline.
EXPERIENCE REQUIREMENTS: Minimum of 10 years of Quality Assurance experience in the medical device industry. Minimum of 5 years of supervisory experience.
OTHER QUALIFICATIONS: Requires written and verbal communication and interpersonal skills. Ability to communicate and interact with individuals at all levels of responsibility.
This position is based in South San Francisco, CA. The expected salary range for this position is $190,000 - $225,000 , plus comprehensive benefits and equity. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training.
Quality Manager
Quality manager job in Vallejo, CA
Compensation: $100,000 - $130,000 plus Bonuses (paid out quarterly and annually) + Excellent Benefits including 401k match! Exciting full-time job opportunity to join a growing Fortune 500 Industrial Manufacturer for the homebuilding industry!
This position will directly report to the Plant Manager and is responsible for carrying out goals and KPI's in support of the company's manufacturing business.
Will be responsible for playing a key role in promoting principles of quality assurance and best practices within the organization.
Will have a team of direct reports and will provide direction, technical support and implement corrective action to ensure conformity to product specifications and prevent quality issues.
Act as a liaison between Sales, Quality Assurance, Production and the customer, conveying all information related to product quality.
Will support production with deployment of QA resources in all areas of need, supports lean initiatives through data collection and statistical methods that improve production efficiency and quality yield, understands customer needs and end use of their products so proper inspection and training methods are implemented and effective.
Also acts as the voice of the customer and is knowledgeable of certification programs and maintain them for compliance.
Job Duties and Responsibilities
Audit the current quality system, ensuring that it is adhered to in accordance with established methods and procedures to achieve the desired frequency.
Monitor the progress and effectiveness of the quality system. Recommend and implement improvements when required.
Provide technical support to the Plant Manager and suggest improvements in methods or control procedures.
Implement an on-line SPC system for gauge control and ensuring the product is within the allowable gauge tolerances.
Establish and maintain quality tracking metrics and reports and make recommendations for improvements.
Analyze and utilize the data from a variety of reports to form problem solving teams to permanently eliminate individual quality issues.
Develop and implement an inspection procedure for incoming raw material (resin, additives, compound) and set-up a supplier corrective action process.
Analyze current quality assessment techniques for inconsistencies and redundancy
Create and implement changes to improve current processes and reduce costs. This includes promoting, training, coaching and assisting in the implementation of key metrics
Develop individuals and teams within the company and create sustainable knowledge and skills for Quality Management implementation through coaching and mentoring.
Assist the Plant Manager in the enforcement of current systems to manufacture the product in accordance with expected quality standards.
Review customer requirements and validate they are met. Develop CTQ's on new products and Control Plans.
Develop and maintain control and distribution of all company quality documentation.
Perform all internal and external audits on behalf of the company's management, specifically management reviews for certification programs.
Verify supplier quality requirements are specified to suppliers on purchased extrusions/products.
Review quality inspection personnel qualifications and training requirements.
Monitor production and quality processes and troubleshoot any errors or problem areas.
Research and gather client and customer feedback for ways to improve products
Track, record, and maintain quality assurance data. This includes holding ticket write-ups, operator quality performance and profile performance.
Support departments with the application and implementation for continuous improvement. This includes promoting, training, coaching and assisting in the implementation of key metrics
Determine a root cause analysis and develop an internal corrective action process to address all quality concerns and warranty claims.
Responsible for leading a team of direct reports in using test tools to identify and implement process improvements where applicable.
Education
Bachelor's degree in Engineering, Quality Management, Business, or related field is required.
QA related certification(s)
Experience
5 years of quality experience, preferably in a manufacturing environment.
2 years of experience in a managerial or leadership role.
Experience with and demonstrate an understanding of quality standards and certification processes.
Demonstrate knowledge of quality management methods, tools and techniques used to create and support the manufacturing needs of the organization.
Skills
Experience in a supervisory role
Applied knowledge of quality principles, data collection, trend analysis and problem-solving skills.
Strong understanding of project management principles.
Ability to show leadership by influencing others.
Accuracy and attention to detail.
Excellent communication skills in English (written and spoken) to produce a variety of business documents.
Managing multiple priorities, effective judgment and time allocation.
Demonstrates a high proficiency in using various applications, including MS Office (Word, Excel and PowerPoint) and be familiar with email and internet applications.
Geoff Savage l Managing Partner
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Easy ApplyManager, Quality
Quality manager job in Hayward, CA
Job DescriptionDescription:
The Manager, Quality, is responsible for overseeing and maintaining the Quality Management System (QMS) in compliance with ISO standards, FDA guidelines (as applicable), and customer requirements for Delphon's Hayward facility. The Hayward facility supports the product realization activities of Gel-Pak, and TouchMark divisions. Gel-Pak develops and manufactures a family of elastomer-based carriers and films designed to provide maximum protection during the shipping, handling and processing of delicate devices. TouchMark provides high quality precision pad printing and manufacturing services to the medical device, diagnostics, and electronics industries. The Manager, Quality is responsible for developing and enforcing quality procedures, leading internal audits, managing the Quality team, and collaborating cross-functionally to drive continuous improvement. The Manager, Quality serves as the ISO Management Representative for the Hayward facility and ensures compliance with all applicable state, federal, and local regulations.
ESSENTIAL DUTIES AND RESPONSIBILITES
Responsibilities include but are not limited to:
• Ensure quality through oversight and guidance throughout design, development, and production.
• Conduct investigations into product and process non-conformances; oversee corrective and preventive actions (CAPA); maintain relevant documentation.
• Handle customer complaints inclusive of RMA (Return Merchandise Authorization), and SCAR (Supplier Corrective Action Requests) s; ensure timely resolution and effective communication with relevant stakeholders (internal and external).
• Maintain the ISO 9001 Quality Management System (QMS); lead internal audits and prepare for customer and regulatory audits.
• Ensure compliance with document control procedures; review and approve quality records and manufacturing deviations.
• Lead Material Review Board (MRB) and support failure analysis, FMEA (Failure Mode Effects Analysis), and risk assessments.
• Develop and maintain control plans, inspection standards, and calibration systems.
• Manage Hayward production employee training records, certifications, and training effectiveness reviews.
• Track and report KPIs, efficiency, and quality metrics for the organization and use DMAIC process to drive real improvements, including YoY reduction of quality issues.
• Collaborate with Engineering, Production, and Customer Service departments to drive continuous improvement.
• Ensure a safe and healthy work environment in accordance with Cal/OSHA and company safety standards.
• Support change control, Coordinate Measuring Machine programming, process capability studies, and Gage Repeatability and Reproducibility (GR&R).
• Participate in ISO management reviews, customer surveys, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), and audits.
• Maintain EQMS (Enterprise Quality Management System), ERP (Enterprise Resource Planning) systems, and Quality department dashboards.
• Review gross margin impacts related to quality and efficiency issues.
• Oversee the daily activities of the department across both the day (6:30 am to 2:00 pm) and swing shifts (2:30 pm to 11:00 pm), including scheduling, training, and performance management. Be on-site from time to time during swing shifts to provide oversight and support. In the absence of the Quality Supervisor, be present on-site as needed to ensure support for both day and shifts.
• Oversee recruitment, training, and performance evaluation within the Quality department, contributing to the onboarding and professional development of the Quality team.
ACCOUNTABILTIES
Supervisory
Supervising, scheduling, assigning, monitoring, and evaluating the work of assigned staff are responsibilities for supervisory positions as well as promoting a respectful, inclusive, and harassment-free workplace.
• Direct Reports: Supervisor, Quality, Quality Technicians.
• Indirect Reports: None
Fiscal
• Department budget development and expense management.
• Departmental purchase order request review and submissions
Requirements:
ESSENTIAL EDUCATION AND TRAINING REQUIREMENTS
• Bachelor's degree in engineering, Quality, or related technical field.
• 5+ years' experience in a quality or regulated manufacturing environment.
• 3+ experience working in a highly regulated industry. Medical device or semiconductor manufacturing preferred.
• Strong working knowledge of ISO 9001; working knowledge of ISO 13485. Familiarity with FDA Quality System Regulations is a plus.
• Strong working knowledge of MS Suite (Outlook, Excel, Word, PowerPoint specifically)
• Proficiency in ERP systems, EQMS, and basic working knowledge of CAD tools.
• Able to read, speak and understand English text, instructions, and diagrams.
• Strong leadership, problem-solving, and organizational abilities.
Work Environment and Physical Demands
• Operates in both an office and manufacturing environment.
• Able to sit, stand, and walk within a confined manufacturing space.
• Able bend, twist, turn, reach, and lift to 50 pounds.
• Frequent use of computers, standard office equipment, and manufacturing-oriented measurement tools.
• Travel required for audits and customer visits will be infrequent, typically 10-15%.
• Maintain 1) reliable and safe transportation to Delphon facilities, customers and for other business travel, 2) valid State-issued driver's license, 3) proper vehicle registration, and 4) State-required minimum automobile insurance coverage requirement.
Director, Parenteral Sterility Assurance
Quality manager job in Concord, CA
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network.
The purpose of this position is to provide oversight and drive / maintain harmonization of technical programs that govern implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Network. This position also influences peers within Lilly globally and at the site level, as well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and enables building technical capability at Lilly sites to ensure the vital capabilities are developed and in place to meet business objectives. Finally, this role provides ad-hoc technical support to Lilly PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing.
Responsibilities:
* Assess differences in current sterility assurance programs across the sites and drive harmonization
* Work closely with site and multi-functional SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved.
* Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved.
* Assume SME leadership role for a specific topic area within Sterility Assurance across the network, including harmonization of aspects of the topic area and facilitation of the knowledge across the network.
* Represent TS/MS on network Science Lead Team and other appropriate governance forums. Ensure that Sterility Assurance programs and similar topics are frequently presented to network team in order to align across sites. Ensure that learnings and best practices are shared across sites: set-up appropriate forums in order to achieve this and present case studies to site SMEs.
* Provide mentoring leadership to site SMEs to help build continue to build capability, particularly at the newer sites or where deep technical expertise is lacking.
* Building, maintaining, and growing capability across the organization in the sterility assurance space
* Provide technical support to new sites/ filling lines during design and start-up activities to ensure sterility assurance programs and process/ product requirements are supported at these sites, particularly while the sites are in early stages of building capability.
* Provide technical support for significant sterility assurance investigations to help identify root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across the other sites.
* Benchmark industry trends and emerging regulatory guidance / requirements in the field through building an extensive peer network and attendance at relevant industry and regulatory meetings and advocacy groups. Advance Lilly agenda in the field. Represent Lilly on relevant external bodies related to Sterility Assurance; be influential in terms of representing Lilly's position on technical/ regulatory positions papers and guidance. Assess new technologies to ensure Lilly stays current with new trends and technologies and share with the network with the goal of staying current with industry best practice.
* Work with PR&D on new technology / platform development and implementation for pipeline products. Influence the agenda within PR&D to ensure the needs of Manufacturing are met, and the control strategies are fit for-purpose for robust and compliant commercial manufacturing.
* Provide ad-hoc technical support to Lilly organizations outside of the PPN including PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing.
* Engage in providing support during regulatory interactions such as RtQ of submissions, and on-site inspections
* Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals
Basic Qualifications:
* BS Degree required.
* MS/PhD in a biological science preferred.
* 10+ years' experience working in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles preferred.
* 10+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment preferred.
* Deep technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, Annex 1 interpretation)
* Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities
* Strong written and oral communication skills
* Ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology
* Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance
* Demonstrated experience influencing site and network leaders to advance technical agenda projects
Additional Preferences:
* Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed.
* Support the establishment of a sterility assurance network or hub in global TSMS
* Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance
* Experience in leading external committees or conferences to ensure Lilly remains a leader in the sterility assurance space
* Work with engineering SME's to support Lilly platforms to maximize the performance and minimize the risk of sterility assurance
* Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options.
* Strong capability to influence personnel and management across the organization
* Close interaction with quality to enable internal audits that identify risks
* Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance.
Additional Information:
* Approximately 25% travel
Lilly currently anticipates that the base salary for this position could range from between $133,500 to $220,000 and will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$133,500 - $246,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplyQuality Manager
Quality manager job in San Francisco, CA
About the Positions
We're seeking Quality Managers at various levels to support large, heavy-civil infrastructure programs-including highways, roads, bridges, transit (including rail and bus), and airport projects delivered through both traditional and alternative methods. These positions will oversee program or project level quality practices including:
quality management (overarching framework and approach to quality),
quality assurance (oversight of design and delivery processes and procedures),
quality control (verification of compliance), and/or
other activities to ensure adequacy, implementation, and effectiveness).
This posting is for future roles and not for a specific opportunity that is available right now. We accept applications and conduct interviews in advance of upcoming hiring needs. When a candidate is selected, their profile is activated in our talent pool for this specialty area. We notify our talent pool candidates first whenever we have a project need. This posting targets San Francisco, CA.
Responsibilities
may include, but are not limited to, the following:
Develop, implement, and/or maintain Quality Management Systems in alignment with ISO 9001:2015 standards and our client requirements.
Establish and manage project-specific QA/QC plans and inspection test plans for design and delivery disciplines.
Oversee quality inspections, audits, and nonconformance reporting; ensure timely closure of nonconformances and implementation of corrective/preventive actions.
Coordinate with design teams, contractors, and consultants to resolve quality issues and ensure consistency throughout design, procurement, construction, and commissioning phases.
Conduct root cause analyses and lead continuous improvement initiatives using Lean Six Sigma, or similar methodologies.
Provide quality training and mentorship to project teams, subcontractors, and field personnel.
Lead quality meetings, compile reports, and deliver project quality performance metrics to internal and external stakeholders.
Attributes
Excellent written and verbal communication and interpersonal skills.
Excellent multitasking, organizational, and time management skills.
Collaborative mindset that fosters teamwork, trust, and positive relationships.
Detail-oriented, observant, logical, tenacious, and investigative.
Natural curiosity, problem-solving abilities, and a passion for continuous improvement both personally and in work.
Ability to analyze complex data and/or situations and resolve them using sound professional judgment.
Confidence in speaking up to address issues and resolve problems.
Minimum Qualifications
Bachelor's degree in civil engineering, quality, construction management, or a related field, or an equivalent combination of education and experience.
10+ years of professional experience in quality management for large (>$500M), complex, heavy-civil infrastructure projects.
Experience leading quality assurance audits.
Expertise with ISO 9001:2015 and industry standard QA/QC practices.
Experience with construction drawings and codes (e.g., IBC, ASTM, ACI, ASME).
Proven experience coordinating with a project management team and providing appropriate levels of support, coaching, and influence.
Proficiency with Microsoft Office Suite/Office 365 (e.g., Outlook, Teams, Word, Excel, PowerPoint, etc.).
Preferred Qualifications
Bachelor's degree in civil engineering, quality, or construction management.
Active ASQ CQE or CQA certification.
Active ISO 9001:2015 Lead Auditor certification.
Active Six Sigma Black or Green Belt certification.
Experience with large (>$500M), complex, heavy-civil infrastructure projects that include highways, roads, bridges, transit (including rail and bus), and/or airport projects.
Experience delivering projects through both traditional and alternative methods (e.g., DB, CM/GC, P3).
Experience in quality roles supporting owners.
Experience managing, coaching, guiding, and assisting technical and administrative staff.
Experience with Microsoft Power BI, Oracle Cloud Analytics, or other dashboard KPI reporting software.
Compensation Details
The salary range listed for this role is $120k-$160k/year ($57-$76/hour). The final salary offered will be based on multiple factors and thoughtfully aligned with each candidate's level of experience, breadth of skills, total education achieved, certifications/licenses that have been obtained, geographic location, etc.
Just LOOK at the Benefits We Offer!
Unlimited flexible time off
Paid holidays
Paid parental leave
Health, dental, and vision insurance
Flexible spending accounts (healthcare and dependent or elder care)
Long-term disability insurance
Short-term disability insurance
Life insurance and accidental death and dismemberment policy
401(k) plan with guaranteed employer contribution
Formal career planning and development program
$2,500 annually toward professional development
Wellness program with monthly wellness stipend
Company cell phone or cell phone plan reimbursement
Free personalized meal planning and nutrition support with a registered dietitian
Free personal financial planning services
Employee assistance program
Employee discounts
Employee referral bonus
Specific plan details and coverage for each benefit noted above will be provided upon offer.
Luster is committed to creating an inclusive work environment with a diverse workforce. All qualified applicants will receive consideration for employment without regard to criminal history, race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. This employer participates in E-Verify. The employer will provide the Social Security Administration (SSA) and, if necessary, the Department of Homeland Security (DHS) with information from each new employee's I-9 to confirm work authorization.
All positions may be subject to a background check and drug test once a conditional offer of employment is made for any convictions directly related to its duties and responsibilities, in accordance with all applicable local, state, and/or federal regulations.
This job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills for the position.
Luster does not accept unsolicited resumes. In the absence of a signed agreement, Luster will not consider or agree to payment of any kind. Any unsolicited resumes presented to Luster personnel, including those submitted to Luster hiring managers, are deemed to be the property of Luster.
Please email ***************** for accommodations necessary to complete the application process.
Auto-ApplyHead of Manufacturing Quality
Quality manager job in South San Francisco, CA
Do you want to change the world? Zipline is on a mission to transform the way goods move. Our aim is to solve the world's most urgent and complex access challenges by building, manufacturing, and operating the first instant delivery and logistics system that serves all humans equally, wherever they are. From powering Rwanda's national blood delivery network and Ghana's COVID-19 vaccine distribution, to providing on-demand home delivery for Walmart, to enabling healthcare providers to bring care directly to U.S. homes, we are transforming the way things move for businesses, governments, and consumers.
The technology is complex, but the idea is simple: a teleportation service that delivers what you need, when you need it. Through robotics and autonomy, we are decarbonizing delivery, decreasing road congestion, reducing fossil fuel consumption and air pollution, while building a more resilient global supply chain.
About You and the Role
Are you a hands-on, systems-level thinker who thrives at the intersection of technical rigor, operational excellence, and team leadership? Do you love building and scaling quality systems that ensure products meet the highest standards of reliability, safety, and performance-without slowing innovation?
As Head of Quality, you will lead Zipline's Quality organization-including our Quality Engineers and Quality Technicians-overseeing the end-to-end quality lifecycle across all feeder lines and top-level assemblies: aircraft, droid, and dock. You will own the quality strategy, execution, and continuous improvement across Incoming Quality Control (IQC), End-of-Line (EOL), and Outgoing Quality Control (OQC) processes to ensure every Zipline product meets the performance and reliability expectations required for global operations.
This role is both strategic and deeply operational. You'll develop scalable quality processes, coach and empower a high-performing team, and use data to drive continuous improvement in first pass yield (FPY), cost of poor quality (COPQ), and field reliability. As a key manufacturing leader, you'll collaborate closely with Production, Manufacturing Engineering, Supply Chain, and Product Design to ensure quality is built into every stage-from supplier through shipment.
You'll need to be comfortable operating in an ambiguous, rapidly evolving environment, balancing day-to-day problem solving with building long-term systems that will scale as Zipline grows globally.
What You'll Do
As Head of Quality, you'll define and drive Zipline's quality vision and roadmap across production and field operations. You'll empower your team to execute with precision, while building the systems, tools, and culture that enable sustained quality excellence.
RESPONSIBILITIES:
Lead and develop Zipline's Quality Engineering and Quality Technician teams, ensuring effective execution across IQC, EOL, and OQC functions.
Define, implement, and continuously improve quality processes across top-level assemblies (aircraft, droid, dock)
Establish and track key quality metrics including first pass yield, defect rates, rework hours, and field quality escapes (modifying these as scale changes)
Drive cross-functional investigations for major production or field quality issues-owning containment, root cause analysis, corrective/preventive actions (CAPA), and communication to leadership.
Drive PFMEAs for all products to be manufactured on the production lines to establish control plans and quality procedures
Partner with Manufacturing Engineering, Supply Chain, and Product Design to implement design-for-quality (DFQ) and process control strategies that reduce variability and improve manufacturability.
Oversee and optimize incoming inspection programs to ensure parts and subassemblies meet quality standards before entering production.
Champion reliability improvement and validation testing at end-of-line to prevent downstream failures and quality escapes to the field.
Own the overall Quality Management System (QMS) maturity roadmap-balancing rigor with practicality as the company scales.
Lead continuous improvement initiatives focused on driving yield improvement, waste reduction, and process standardization.
Build and foster a culture of accountability, root cause problem-solving, and pride in quality across the production floor.
Serve as the senior quality voice in leadership reviews-providing transparency into risks, performance trends, and improvement priorities.
Must Have Experience / Skill Sets
10+ years of experience in manufacturing quality, reliability, or production engineering, including 3+ years in a leadership role managing quality teams.
Experience with scaling a quality system from low prototype production to low volume production (100/wk) to high volume production (1000s/wk) with complex electro-mechanical hardware (automotive, small aircraft, robotics, etc)
Strong understanding of quality engineering tools and methodologies: PFMEA, control plans, and CAPA.
Demonstrated success in scaling quality systems across complex electro-mechanical products.
Hands-on experience in production environments managing inspection, testing, and validation activities.
Proven ability to reduce quality escapes and improve first pass yield in high-mix, low- to mid-volume operations.
Strong data analysis skills; comfortable using quality metrics to drive improvement and accountability.
Experience collaborating closely with Manufacturing Engineering, Supply Chain, and Design Engineering teams to influence product and process quality.
Excellent leadership and communication skills-capable of motivating teams and driving cross-functional alignment.
Ability to balance hands-on problem solving with long-term strategic planning.
Comfort operating in a fast-paced, ambiguous, and rapidly scaling environment.
Nice to Have
Experience in robotics or automotive manufacturing.
Background in supplier quality and global production scaling.
Familiarity with MES, ERP, and PLM systems for quality data traceability.
Experience managing automated or semi-automated inspection systems.
What Else You Need to Know
Zipline is an equal opportunity employer and prohibits discrimination and harassment of any kind. We value diversity and welcome applications from those who are traditionally underrepresented in tech. If you like the sound of this position but are not sure if you are the perfect fit, please apply!
Auto-ApplyQuality Manager, Supplier QA
Quality manager job in South San Francisco, CA
At Veracyte, we offer exciting career opportunities for those interested in joining a pioneering team that is committed to transforming cancer care for patients across the globe. Working at Veracyte enables our employees to not only make a meaningful impact on the lives of patients, but to also learn and grow within a purpose driven environment. This is what we call
the Veracyte way
- it's about how we work together, guided by our values, to give clinicians the insights they need to help patients make life-changing decisions.
Our Values:
We Seek A Better Way: We innovate boldly, learn from our setbacks, and are resilient in our pursuit to transform cancer care
We Make It Happen: We act with urgency, commit to quality, and bring fun to our hard work
We Are Stronger Together: We collaborate openly, seek to understand, and celebrate our wins
We Care Deeply: We embrace our differences, do the right thing, and encourage each other
The Position:
As the Quality Manager, Supplier QA you will lead the qualification, monitoring, and oversight of Veracyte's Contract Manufacturers (CMOs) and IVD suppliers. You will serve as the primary quality interface between Veracyte and its external manufacturing partners, ensuring that all products and processes meet applicable regulatory requirements (e.g., ISO 13485, FDA QSR, IVDR) and internal quality standards. The ideal candidate brings strong supplier quality experience, auditing, and managing external manufacturing relationships. This is a hybrid role (remote and in office up to 3 days a week as necessary) and is based out of our headquarters in South San Francisco (SSF), California, United States.
Responsibilities:
Own and lead the Supplier Quality Management to ensure vendor products, processes and services are provided in compliance with applicable regulations (e.g., FDA, ISO 13485, EU IVDR, etc.) and Veracyte's quality standards.
Establish and maintain supplier and CMO oversight strategies, including risk-based qualification, periodic performance monitoring, and quality metrics.
Serve as the primary Quality lead for supplier and CMO relationships, providing quality input during supplier selection, qualification, and issue resolution.
Lead and execute supplier audits, ensure timely closure of audit findings, and drive continuous improvement across the supplier base.
Develop, implement, and maintain supplier quality metrics and monitoring programs.
Lead investigations of supplier and CMO related quality incidents, perform root cause analysis, assess impact on product or regulatory compliance
Oversee and maintain the Approved Supplier List (ASL) and associated supplier documentation in compliance with ISO 13485 and IVDR.
Lead suppliers and CMOs qualification activities, including risk assessments, audits, and quality agreements
Issue, track, and close Supplier Corrective Action Requests (SCARs) related to supplier non-conformances
Review and approve supplier change notifications and deviations to assess the impact on product quality and regulatory compliance.
Ensure appropriate validation and verification activities are performed for supplier-initiated changes
Collaborate cross-functionally with R&D, Regulatory Affairs, and Supply Chain to support new product introductions and design transfers to CMOs.
Support regulatory inspections and notified body audits, serving as the SME for supplier quality.
Champion continuous improvement initiatives to strengthen supplier quality processes and reduce external quality risk.
Who You Are:
Qualifications:
Bachelor's degree in Life Sciences, Engineering, Biomedical Engineering, Biotechnology, or related technical field
A minimum of 6 - 7 years of progressive experience in Quality Assurance within the medical device or IVD industry.
In‑depth working knowledge of in‑vitro diagnostic device quality requirements, including ISO 13485:2016, IVDR (EU 2017/746) and, ISO 14971:2019 risk management
Prior experience in implementing and establishing a Supplier Quality program that is compliant to ISO13485 and IVDR requirements
Demonstrated success in supplier quality leadership, audit execution, and external manufacturing oversight.
Willingness to travel (up to ~30%) to supplier and CMO sites.
Strong written and verbal communication skills; demonstrated ability to author clear SOPs, technical documents, and audit responses
Strong organization skills to manage multiple simultaneous projects in a fast-paced environment.
Attention to detail in understanding and documenting complex quality issues
Highly organized, self-motivated, and comfortable working in a fast-paced IVD environment.
ISO 13485 Lead Auditor or equivalent lead auditor certificate is preferred
#LI-Hybrid
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to years of experience, skillset, geographic location, industry, education, etc. Base pay is one part of the Total Package that is provided to compensate and recognize employees for their work, and this role may be eligible for additional discretionary bonuses/incentives, and restricted stock units.
Pay range$128,000-$149,000 USDWhat We Can Offer You
Veracyte is a growing company that offers significant career opportunities if you are curious, driven, patient-oriented and aspire to help us build a great company. We offer competitive compensation and benefits, and are committed to fostering an inclusive workforce, where diverse backgrounds are represented, engaged, and empowered to drive innovative ideas and decisions. We are thrilled to be recognized as a 2024 Certified™ Great Place to Work in both the US and Israel - a testament to our dynamic, inclusive, and inspiring workplace where passion meets purpose.
About Veracyte
Veracyte (Nasdaq: VCYT) is a global diagnostics company whose vision is to transform cancer care for patients all over the world. We empower clinicians with the high-value insights they need to guide and assure patients at pivotal moments in the race to diagnose and treat cancer. Our Veracyte Diagnostics Platform delivers high-performing cancer tests that are fueled by broad genomic and clinical data, deep bioinformatic and AI capabilities, and a powerful evidence-generation engine, which ultimately drives durable reimbursement and guideline inclusion for our tests, along with new insights to support continued innovation and pipeline development. For more information, please visit **************** or follow us on LinkedIn or X (Twitter).
Veracyte, Inc. is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or disability status. Veracyte participates in E-Verify in the United States. View our CCPA Disclosure Notice.
If you receive any suspicious alerts or communications through LinkedIn or other online job sites for any position at Veracyte, please exercise caution and promptly report any concerns to ********************
Auto-ApplyValidation Operations Standards & Quality Program Manager
Quality manager job in San Francisco, CA
Waymo is an autonomous driving technology company with the mission to be the world's most trusted driver. Since its start as the Google Self-Driving Car Project in 2009, Waymo has focused on building the Waymo Driver-The World's Most Experienced Driver™-to improve access to mobility while saving thousands of lives now lost to traffic crashes. The Waymo Driver powers Waymo's fully autonomous ride-hail service and can also be applied to a range of vehicle platforms and product use cases. The Waymo Driver has provided over ten million rider-only trips, enabled by its experience autonomously driving over 100 million miles on public roads and tens of billions in simulation across 15+ U.S. states.
Waymo Operations exists to deliver the Waymo Driver to the world. We are a global team building and scaling the world's first and leading autonomous fleet and operations platform. From component sourcing to end customer management, we enable and create value for Waymo through scaled and orchestrated deployment of the Waymo Driver. At Waymo, we are dedicated to building a culture that promotes inclusivity and celebration. We value diverse backgrounds, perspectives, and experiences; recognize that inclusive actions lead to equitable outcomes; and support and encourage all team members to share their ideas to help Waymo better serve the communities in which we operate.
You will:
Develop and maintain standard operating procedures, playbooks, and checklists based on safety, regulatory compliance, and program requirements.
Monitor validation practices for adherence to quality standards, conduct audits and analyze feedback.
Design and execute a formal change management process for all modifications to validation operations standards and procedures.
Assess the impact of proposed changes on operations, safety, and project timelines. Develop clear communication plans and lead training efforts to ensure smooth transitions and universal adoption of new processes.
Proactively identify potential risks associated with changes and develop robust mitigation strategies to minimize disruption to operations.
Track key metrics related to performance and quality, analyze results, and use data-driven insights to drive continuous improvement.
Conduct detailed process mapping of current workflows to identify inefficiencies and drive lean principles, ensuring consistency and repeatability of validation outcomes.
Facilitate root cause analysis for process failures, and quality deviations to implement corrective and preventative actions to address underlying issues.
You have:
7+ years of experience in program or project management, quality assurance, or process improvement within the automotive, aerospace, or a related high-growth tech company .
Proven track record of successfully leading complex organizational change initiatives and implementing formal change control processes.
Exceptional analytical and problem-solving skills with a meticulous attention to detail.
Strong leadership, communication, and interpersonal skills, with the ability to influence and collaborate effectively with diverse cross-functional teams.
Strong understanding of quality management principles, audit processes, and data analysis.
Bachelor's degree in Engineering, Operations Management, Business Administration, or a related field.
We prefer:
Master's degree or relevant certifications (PMP, Lean Six Sigma Black Belt) preferred.
In-depth knowledge of Quality Management Systems and process improvement methodologies (e.g., Lean Six Sigma).
Experience in developing and implementing training programs, preferably in a technical or operational setting.
#LI-Hybrid
The expected base salary range for this full-time position across US locations is listed below. Actual starting pay will be based on job-related factors, including exact work location, experience, relevant training and education, and skill level. Your recruiter can share more about the specific salary range for the role location or, if the role can be performed remote, the specific salary range for your preferred location, during the hiring process.
Waymo employees are also eligible to participate in Waymo's discretionary annual bonus program, equity incentive plan, and generous Company benefits program, subject to eligibility requirements.
Salary Range$152,000-$192,000 USD
Auto-ApplyContract Manufacturing Quality Manager
Quality manager job in Walnut Creek, CA
ABOUT US AT KINDER'S:
What's it like to work at Kinder's? Well, there's a lot of snacking and geeking out over what we all cooked over the weekend. But beyond that, there's also plenty of hard work. Because we don't just like flavor, we're obsessed with it. With over 100 products sold nationwide, we're now a top-five brand in multiple flavor categories at Costco, Walmart, Whole Foods, and more. But we're not your typical CPG company. Privately held and founder-led, we like to think of ourselves as a pirate ship in a sea of cruise ships. Our crew is adventurous and fearless. We chart our own course and chase big ideas to make food unforgettable. As we expand globally and approach $1 billion in revenue, we need other smart-and-scrappy, flavor-obsessed people to come aboard. If you're looking for a place where you can see the real impact of your work, this is it. Every day, you'll be part of a journey to add flavor to millions of meals and lives.
How you'll have an impact at Kinder's: The Co-Manufacturing Quality Manager will be responsible for quality assurance at our co-pack partners for our high-growth flavor brand and will play a critical role in both defining and driving compliance with our high quality standards across our co-pack network. You will partner with Kinder's Co-Pack/Operations, Corporate Quality, and Product Development teams, to build an organization and processes that ensure Kinder's delivers high quality and amazing tasting products consistently while adhering to industry best practices for food safety and quality assurance.
What are the Key Responsibilities of this Role:
Quality Assurance Strategy and Execution - 35%
Quality / Food Safety Procedures
Work with internal and external teams to drive clear understanding of quality standards and establish robust capability to drive compliance with the goal of consistent quality attainment.
Develop / implement continuous improvement program with collaboration with manufacturing partners to ensure consistent elevation of quality standards.
Testing Program
Evaluate / refine existing company testing procedures and work with internal stakeholders and manufacturing partners to develop robust, balanced program to ensure compliance with key standards.
Process Development
Collaborate with PD and manufacturing partners to evaluate process development opportunities to drive consistency in lot-level quality attainment.
Consumer Quality Support
Track / maintain database of consumer complaints or other quality issues.
Identify trends in consumer issues and, where applicable, develop corrective action plans for vendor partners or work with internal PD team to develop reformulation strategies.
Co-Manufacturing Management; Audit / Compliance - 35%
Refine company audit process / manuals and develop clear, effective communication strategy with key manufacturing partners.
Collaborate with operations / PD teams to evaluate new manufacturing partners and, where applicable, develop remediation / process improvement programs to ensure compliance with company standards.
Maintain audit / regulatory / and SOP tracking systems for manufacturing partners to ensure all documentation is current and compliant with company and / or regulatory standards.
Oversee testing at co-packers to ensure products are free of defects and in compliance with quality standards. Participate in investigations, identify quality issues, and create Corrective and Preventative Actions (CAPAs).
Develop annual / quarterly vendor business reviews to highlight quality trends and key areas for improvement.
Regulatory / Documentation - 15%
Monitor FDA /USDA regulatory activities and plant compliance with regulatory standards and act as a liaison for all manufacturing locations, ensuring regulatory compliance within the business unit.
Work with PD to catalog robust item specifications and ensure that manufacturing partners are delivering consistent compliance with established standards.
Cross-Functional Partnership - 15%
Lead cross-functional team to ensure quality standards while also achieving aggressive commercialization timelines.
Drive clear cross-functional understanding of key quality issues / drivers and help team make intentional, active trade-offs to balance quality, brand, and commercial objectives.
Identify any sources of food safety risk and drive clear organizational understanding and alignment on how to achieve “zero-tolerance” standard.
Identify key sources of business risk from quality issues (e.g. variance in appearance, flavor profile, packaging look / feel) and highlight trade-offs to senior management.
What You Bring to the Table
Education / Experience
B.S. in Food Science or related field preferred; A.S required.
PCQI & HACCP required, Better Process Control School (Acidified Food School) preferred.
7+ years relevant work experience in FS/QA/QC in CPG Food and Beverage industry.
Advanced level food safety technical knowledge, including demonstrated knowledge of microbiology, allergens, FSMA and other food regulations.
Experience in innovation and/or product development is a plus.
Experience with food audit procedures and systems (e.g. BRC, SQF, Tracegains) strongly preferred.
Track record in agile creative thinking, generation of standards / processes, and working with internal and external partners.
Collaborative business partner with a track record of helping internal and external stakeholders identify win-win solutions and driving alignment around best course of action and accountability for delivering committed outcomes.
Proven strategic thinker excited by a dynamic, highly innovation-focused model.
Strong analytical & quantitative acumen with ability to collect and use data to drive better, faster decision-making.
Strong project management skills and understanding of new product development process from ideation to execution.
Personal Characteristics
Business builder who owns and drives results.
Growth mindset with an excitement to learn (and teach).
Thrive in a dynamic, lean, and agile environment with proven record of completing projects on time in full through excellent cross functional team management, leadership, communication and influence.
Self-starter who takes initiative and speaks their mind.
Excited to be part of a fast-moving team with the ability to be a leader and a follower.
Enjoy making decisions and finding ways to say ‘yes' as often as possible to impactful and important priorities.
Things About the Way We Work
No two days here are the same.
We try to be good team members and good communicators, but we don't live by hierarchy and structure - everyone is a difference maker here.
We make a lot of decisions in the face of incomplete information - our team embraces ambiguity and tries to make good decisions fast rather than great decisions slow
We believe our job is to take smart risk, not to eliminate risk.
We believe in growing our skills and becoming a better company with more managerial expertise, but we are an entrepreneurial company at heart.
We aren't trying to be average - we want to do exceptional things and we are willing to work hard to achieve them.
Location & Travel
The position will be based out of our 20,000 sq. foot office in Walnut Creek, CA. We strongly believe in the power of culture and community and have a hybrid work structure with 4 days in the office on a weekly basis to encourage collaboration and personal connections that will allow us to better serve our customers and consumer and to have more fun. We have 1 flex day per week with employees having the opportunity to choose to be either in the office or to work from home based on what makes most sense for them.
Travel approximately 50% to co-manufacturing partners and industry conferences.
The expected starting salary range for this role is $120,000- $140,000 per year.
We may ultimately pay more or less than the posted range based on the location of the role. The amount a particular employee will earn within the salary range will be based on factors such as relevant education, qualifications, performance and business needs.
Auto-ApplyQuality Control Manager
Quality manager job in Fairfield, CA
We are seeking a highly qualified Quality Control Manager to oversee a renovation build project in Fairfield, CA to work onsite at Travis Airforce Base. The ideal candidate will have a 4-year engineering degree and a minimum of 5 years of experience working on federal projects. Experience with NAVFAC projects is highly desirable. Candidates must also possess CQM and OSHA 30 certifications.
Responsibilities:
- Develop and implement quality control processes and procedures to ensure compliance with federal regulations and project specifications
- Conduct regular inspections and audits to identify and address quality issues
- Collaborate with project managers, subcontractors, and other stakeholders to resolve quality-related issues
- Provide training and guidance to project team members on quality control requirements and best practices
- Maintain accurate records and documentation related to quality control activities
- Communicate effectively with project stakeholders to address quality concerns and promote a culture of quality excellence
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to ********************.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: ****************************************************
Skills and Requirements
- Bachelor's degree in engineering or a related field
- Minimum of 10 years of experience in construction
- Minimum of 2 years of experience as a Quality Control Manager
- CQM Certification
- EM 385 - OSHA 30
Quality Control Manager (QCM)
Quality manager job in Fairfield, CA
Quality Control Manager (QCM) The QCM is responsible for implementing and managing the contractor's Quality Control Program (QCP) to ensure all O&M activities meet or exceed contractual requirements. This dual-hatted position also oversees the safe, efficient, and compliant operation and maintenance of the Central Utility Plant, ensuring uninterrupted delivery of critical utilities to the Medical Treatment Facility and supported facilities. The role focuses on scheduled, unscheduled, and emergency maintenance, regulatory compliance, and safety management.
Tasks and Capabilities Required:
* Develop, maintain, and execute the QCP in compliance with the PWS.
* Conduct regular inspections, tests, and performance evaluations across all O&M functions.
* Maintain accurate QC records and coordinate closely with Government QA staff.
* Provide remedial training and corrective action when deficiencies are identified.
* Ensure all work complies with applicable safety standards, including OSHA, NFPA, and EM 385-1-1.
Mandatory Experience and Certifications:
* Minimum 2 years' Quality Control experience in construction or facility management.
* Minimum 2 years' experience in comparably sized health facilities.
* OSHA 30-Hour Certification.
* Preferred/Desired Certifications:
* ASQ Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE).
Disclaimer:
The responsibilities and qualifications outlined above are intended to describe the general nature and level of work performed by those in this position. They are not an exhaustive list of all duties and skills required. The company reserves the right to modify job duties or assign additional duties as needed.
Tentative Start Date: 01/01/2026 [5 Year Contract]
Special Qualifications/Requirements:
Must be able to successfully pass, as required, a federal, state, or local government's background investigation.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
We maintain a drug-free workplace and perform pre-employment substance abuse testing. The contractor will not discharge or, in any other manner, discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
Job Description last Updated: 08/19/2025
Clinical Quality Program Manager
Quality manager job in Walnut Creek, CA
Shift: Monday - Friday; 8:00am - 5:00pm PT
Hybrid 1: This role requires associates to be in-office 1 day per week, fostering collaboration and connectivity, while providing flexibility to support productivity and work-life balance. This approach combines structured office engagement with the autonomy of virtual work, promoting a dynamic and adaptable workplace. Internal candidates may be considered with a confirmed virtual exception on file.
Please note that per our policy on hybrid/virtual work, candidates not within a reasonable commuting distance from the posting location(s) will not be considered for employment, unless an accommodation is granted as required by law
The Clinical Quality Program Manager is responsible for serving as a liaison with and overseeing the quality improvement activities/projects/programs for one or more states within a major line of business.
How you will make an impact:
Leads state change to health plan level quality strategy meetings, develops a quality plan, and ensures integration of quality into the overall business process.
Works with the clinical intervention team to design studies to identify barriers to medical interventions.
Ensures that study methodology is sound and appropriate reporting is in place.
Develops performance improvement plans and oversees the clinical quality improvement activities/projects to improve the quality of care for members.
Assures compliance with corporate QI work plans.
Assures that all QI activities are relevant to the needs of targeted population.
Maintains effective documentation of research programs to meet regulatory and Accreditation Standards.
Provides oversight to assure accurate and complete quantitative analysis of clinical data and presentation of data analysis results.
Participates in and provides input to the development of new product designs for major line of business.
Oversees the implementation of new initiatives.
Leads interactions with regulators or oversight entities.
Oversees quality improvement activities for the largest, most complex state programs.
Minimum Requirements:
Requires a BS in health administration, nursing, or a related clinical field; 4 years of health care quality or data analysis experience; or any combination of education and experience, which would provide an equivalent background.
Preferred skills, capabilities, or experiences:
Current unrestricted license, certification in applicable field (i.e. CPHQ) and/or a MS in the health field (i.e. Nursing) is preferred.
Intermediate Excel and PowerPoint skills
Prior experience with HEDIS and NCQA Health Plan Accreditations
For candidates working in person or virtually in the below location(s), the salary* range for this specific position is $95,680.00 to $149,760.00
Locations: California
In addition to your salary, Elevance Health offers benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). The salary offered for this specific position is based on a number of legitimate, non-discriminatory factors set by the Company. The Company is fully committed to ensuring equal pay opportunities for equal work regardless of gender, race, or any other category protected by federal, state, and local pay equity laws
.
* The salary range is the range Elevance Health in good faith believes is the range of possible compensation for this role at the time of this posting. This range may be modified in the future and actual compensation may vary from posting based on geographic location, work experience, education and/or skill level. Even within the range, the actual compensation will vary depending on the above factors as well as market/business considerations. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
Job Level:
Non-Management Exempt
Workshift:
1st Shift (United States of America)
Job Family:
QLT > Clinical Quality
Please be advised that Elevance Health only accepts resumes for compensation from agencies that have a signed agreement with Elevance Health. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Elevance Health.
Who We Are
Elevance Health is a health company dedicated to improving lives and communities - and making healthcare simpler. We are a Fortune 25 company with a longstanding history in the healthcare industry, looking for leaders at all levels of the organization who are passionate about making an impact on our members and the communities we serve.
How We Work
At Elevance Health, we are creating a culture that is designed to advance our strategy but will also lead to personal and professional growth for our associates. Our values and behaviors are the root of our culture. They are how we achieve our strategy, power our business outcomes and drive our shared success - for our consumers, our associates, our communities and our business.
We offer a range of market-competitive total rewards that include merit increases, paid holidays, Paid Time Off, and incentive bonus programs (unless covered by a collective bargaining agreement), medical, dental, vision, short and long term disability benefits, 401(k) +match, stock purchase plan, life insurance, wellness programs and financial education resources, to name a few.
Elevance Health operates in a Hybrid Workforce Strategy. Unless specified as primarily virtual by the hiring manager, associates are required to work at an Elevance Health location at least once per week, and potentially several times per week. Specific requirements and expectations for time onsite will be discussed as part of the hiring process.
The health of our associates and communities is a top priority for Elevance Health. We require all new candidates in certain patient/member-facing roles to become vaccinated against COVID-19 and Influenza. If you are not vaccinated, your offer will be rescinded unless you provide an acceptable explanation. Elevance Health will also follow all relevant federal, state and local laws.
Elevance Health is an Equal Employment Opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, citizenship status, color, creed, disability, ethnicity, genetic information, gender (including gender identity and gender expression), marital status, national origin, race, religion, sex, sexual orientation, veteran status or any other status or condition protected by applicable federal, state, or local laws. Applicants who require accommodation to participate in the job application process may contact ******************************************** for assistance. Qualified applicants with arrest or conviction records will be considered for employment in accordance with all federal, state, and local laws, including, but not limited to, the Los Angeles County Fair Chance Ordinance and the California Fair Chance Act.
Auto-ApplyServiceNow QA Manager
Quality manager job in San Francisco, CA
Must Have Technical/Functional Skills * Lead workshops to understand customer's business imperatives, technology landscape and transformation priorities. * Lead ServiceNow implementation and digital transformation journeys for ITSM, ITOM, FSM, Data Migrations, catalog forms
* Interfacing implementation teams, explaining customer requirements, to ensure a successful transition and delivery execution.
* Experience in ITSM, ITOM, FSM, Data Migrations, catalog forms.
* Experience leading large scale implementation and transformation programs is preferable.
* Experience in Advisory, Consulting, and Solutioning HRSD, WSD and S2P is preferred.
* Experience in collaborating with multiple stakeholders from within the organization, customers as well as partners.
* Perform framework driven assessment to benchmark customer's maturity levels across specific domains & functions.
* Consult clients on improving employee experience, HR Agent experience, optimizing workflows, and simplifying HR Service Delivery.
* Map customers' business problems to ServiceNow solutions.
* Present a PoV to customers on how to leverage the platform to address business priorities.
* Prepare business case for ServiceNow driven transformation.
* Craft a solution roadmap aligned with customer's business and technology strategy
* Expertise ServiceNow deployments, ITSM, ITOM, FSM, Data Migrations, catalog forms , consolidations, upgrades, integration with other third-party systems, Orchestration.
* Understand Architecture Solution for the implementation or Maintenance of ServiceNow platform.
* Develop a design aligned with the Architecture and technical requirements.
* Work with Architect and customers for the technical requirements, document them, play back and baseline.
* Work effectively with geographically diverse teams (offshore) to deliver timely responses to clients and client account teams.
Roles & Responsibilities
Lead a team of ServiceNow developers, web designers, integration SMEs and QA analysts to build and deploy the applications meeting the customer requirements.
* Evolve business solutions, articulate as appropriate to client audiences.
* Actively engages in Governance call, allowing to grasp the initial user requests' requirements effectively.
* Collaborates with both internal and external stakeholders to enhance the story with relevant details, ensuring that the requirements are communicated in a clear and understandable manner for developers, thereby enhancing their productivity.
* Closely collaborates with team leads and architects to facilitate the creation and documentation of appropriate solutions within the story.
* Work alongside leaders to maintain awareness of the customer experience team's progress and achievements.
* Diligently tracks all the stories that need to be delivered within a given timeframe.
* Experience working with stakeholders to understand, document, and prioritize requirements for process and ServiceNow enhancements.
* Experience defining and documenting governance processes and procedures and ensuring that the processes are followed
Generic Managerial Skills, If any
* Create and execute development plans as appropriate to meet changing needs and requirements.
* Good Communication and presentation skills, Client handling
* Thought leadership - Steer the team towards success by creating a trust environment.
* Good at creating required information for Reporting and Dashboards
In order to comply with U.S. laws and regulations applicable to this position, the person(s) hired must possess the ability to obtain US Security Clearance which requires that the person be a U.S. Citizen, a U.S. Permanent Resident (i.e., a "Green Card Holder"), or a Political Asylee or Refugee.
Salary Range: $120,000 $140,000 Year
TCS Employee Benefits Summary:
Discretionary Annual Incentive.
Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
Family Support: Maternal & Parental Leaves.
Insurance Options: Auto & Home Insurance, Identity Theft Protection.
Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement.
Time Off: Vacation, Time Off, Sick Leave & Holidays.
Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.
#LI-SP1
Director, GCP Quality Assurance
Quality manager job in South San Francisco, CA
Job Description
Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company's Native Complex Platform™ recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular context. This approach enables novel access to modern structural and screening technologies used in industrial-scale drug discovery for the entire class of GPCRs. Septerna has an emerging pipeline of GPCR-targeted small molecule programs with potential for growth to target many GPCRs that have been undruggable and unexploited to date.
We are excited to expand our multidisciplinary team of individuals focused on creating revolutionary medicines to address the unmet needs of patients. At Septerna we strive to embrace diversity of thought, expertise, and background through collaboration. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission. We share a fearless pursuit of ground-breaking innovations and cultivate an environment where our employees succeed by learning from each other and working as a team.
We are committed to the development of meaningful therapeutics for patients with indications of high unmet need. This is a tremendous opportunity to work with talented individuals on the frontlines of therapeutic discovery and development. You will directly help move therapies through preclinical research, positioning them for success in the clinic. The successful candidate will add their passion, unique talents, and expertise to a dynamic team motivated to discover new disease-modifying therapeutics for patients in a fast-paced environment.
For more information see: *****************
THE ROLE
We are seeking an experienced, dynamic, and results-driven Associate Director / Director of GCP Quality Assurance our on-site team in South San Francisco. This role is critical in providing both strategic and operational quality oversight of clinical studies and vendor programs, ensuring compliance with ICH GCP and global regulatory requirements, and upholding our high standards for data integrity. The ideal candidate will collaborate closely with clinical study teams and cross-functional partners, fostering a culture of quality and maintaining a state of continual GCP compliance across all programs.
Responsibilities:
Provide quality oversight and GCP guidance to clinical study teams and CROs/vendors to ensure compliance with ICH GCP, applicable regulatory requirements, and Septerna standards.
Ensure clinical trials are conducted in accordance with GCP principles, producing high-quality and reliable data.
Evaluate clinical trial documentation, study processes, and operational plans to confirm alignment with Septerna expectations and applicable regulations.
Interpret and apply clinical and regulatory compliance requirements to support Septerna's objectives and ensure effective implementation across programs.
Collaborate with clinical study teams to provide vendor quality oversight, identify and assess risks, and recommend appropriate remediation actions.
Develop and execute GCP audit plans for assigned clinical studies as part of ongoing quality oversight.
Partner with clinical functions to provide quality guidance and drive the implementation of fit-for-purpose procedures that ensure data and documentation are generated and managed in compliance with GCP.
Work with cross-functional teams to assess and manage risks associated with vendors, supporting study compliance, data integrity, and participant safety.
Assist in periodic reporting of key quality metrics to leadership to support continuous improvement in GCP compliance across Septerna.
Promote a culture of quality through effective communication, training, and proactive engagement with internal and external stakeholders.
Qualifications
Bachelor's degree in life sciences or a related field; an advanced degree is preferred.
8-10 years of professional experience in Quality Assurance within the biopharmaceutical industry, with progressive responsibilities in Clinical QA.
Minimum of 6 years of direct GCP audit experience, including investigator sites, CROs, and other clinical vendors.
Proven ability to evaluate the effectiveness of CAPAs and follow up on audit findings to ensure timely and complete resolution.
Strong knowledge of ICH GCP and applicable global regulatory requirements governing clinical research.
Demonstrated experience providing GCP oversight of clinical studies and vendor programs.
Skilled in authoring and revising SOPs, implementing process improvements, and ensuring quality systems remain phase-appropriate and fit-for-purpose.
Demonstrated ability to assess compliance risks, interpret regulations, and implement practical, risk-based quality solutions.
Excellent collaboration and communication skills with the ability to work effectively across functional areas and external partners.
Highly organized and detail-oriented, with the ability to manage multiple priorities in a fast-paced, evolving environment.
The anticipated salary range for candidates who will work in South San Francisco, CA is $220,000 - $240,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.
Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.
We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Septerna participates in the E-Verify program.
California Consumer Privacy Act Privacy Notice For Job Applicants. If you are a California resident, click here for our CCPA Notice.
Clinical Quality Program Manager
Quality manager job in Walnut Creek, CA
**Shift:** Monday - Friday; 8:00am - 5:00pm PT **Hybrid 1:** This role requires associates to be in-office **1** day per week, fostering collaboration and connectivity, while providing flexibility to support productivity and work-life balance. This approach combines structured office engagement with the autonomy of virtual work, promoting a dynamic and adaptable workplace. Internal candidates may be considered with a confirmed virtual exception on file.
_Please note that per our policy on hybrid/virtual work, candidates not within a reasonable commuting distance from the posting location(s) will not be considered for employment, unless an accommodation is granted as required by law_
The **Clinical Quality Program Manager** is responsible for serving as a liaison with and overseeing the quality improvement activities/projects/programs for one or more states within a major line of business.
**How you will make an impact:**
+ Leads state change to health plan level quality strategy meetings, develops a quality plan, and ensures integration of quality into the overall business process.
+ Works with the clinical intervention team to design studies to identify barriers to medical interventions.
+ Ensures that study methodology is sound and appropriate reporting is in place.
+ Develops performance improvement plans and oversees the clinical quality improvement activities/projects to improve the quality of care for members.
+ Assures compliance with corporate QI work plans.
+ Assures that all QI activities are relevant to the needs of targeted population.
+ Maintains effective documentation of research programs to meet regulatory and Accreditation Standards.
+ Provides oversight to assure accurate and complete quantitative analysis of clinical data and presentation of data analysis results.
+ Participates in and provides input to the development of new product designs for major line of business.
+ Oversees the implementation of new initiatives.
+ Leads interactions with regulators or oversight entities.
+ Oversees quality improvement activities for the largest, most complex state programs.
**Minimum Requirements:**
+ Requires a BS in health administration, nursing, or a related clinical field; 4 years of health care quality or data analysis experience; or any combination of education and experience, which would provide an equivalent background.
**Preferred skills, capabilities, or experiences:**
+ Current unrestricted license, certification in applicable field (i.e. CPHQ) and/or a MS in the health field (i.e. Nursing) is preferred.
+ Intermediate Excel and PowerPoint skills
+ Prior experience with HEDIS and NCQA Health Plan Accreditations
**For candidates working in person or virtually in the below location(s), the salary* range for this specific position is $95,680.00 to $149,760.00**
**Locations: California**
In addition to your salary, Elevance Health offers benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). The salary offered for this specific position is based on a number of legitimate, non-discriminatory factors set by the Company. The Company is fully committed to ensuring equal pay opportunities for equal work regardless of gender, race, or any other category protected by federal, state, and local pay equity laws _._
* The salary range is the range Elevance Health in good faith believes is the range of possible compensation for this role at the time of this posting. This range may be modified in the future and actual compensation may vary from posting based on geographic location, work experience, education and/or skill level. Even within the range, the actual compensation will vary depending on the above factors as well as market/business considerations. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
Please be advised that Elevance Health only accepts resumes for compensation from agencies that have a signed agreement with Elevance Health. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Elevance Health.
Who We Are
Elevance Health is a health company dedicated to improving lives and communities - and making healthcare simpler. We are a Fortune 25 company with a longstanding history in the healthcare industry, looking for leaders at all levels of the organization who are passionate about making an impact on our members and the communities we serve.
How We Work
At Elevance Health, we are creating a culture that is designed to advance our strategy but will also lead to personal and professional growth for our associates. Our values and behaviors are the root of our culture. They are how we achieve our strategy, power our business outcomes and drive our shared success - for our consumers, our associates, our communities and our business.
We offer a range of market-competitive total rewards that include merit increases, paid holidays, Paid Time Off, and incentive bonus programs (unless covered by a collective bargaining agreement), medical, dental, vision, short and long term disability benefits, 401(k) +match, stock purchase plan, life insurance, wellness programs and financial education resources, to name a few.
Elevance Health operates in a Hybrid Workforce Strategy. Unless specified as primarily virtual by the hiring manager, associates are required to work at an Elevance Health location at least once per week, and potentially several times per week. Specific requirements and expectations for time onsite will be discussed as part of the hiring process.
The health of our associates and communities is a top priority for Elevance Health. We require all new candidates in certain patient/member-facing roles to become vaccinated against COVID-19 and Influenza. If you are not vaccinated, your offer will be rescinded unless you provide an acceptable explanation. Elevance Health will also follow all relevant federal, state and local laws.
Elevance Health is an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to age, citizenship status, color, creed, disability, ethnicity, genetic information, gender (including gender identity and gender expression), marital status, national origin, race, religion, sex, sexual orientation, veteran status or any other status or condition protected by applicable federal, state, or local laws. Applicants who require accommodation to participate in the job application process may contact ******************************************** for assistance.
Qualified applicants with arrest or conviction records will be considered for employment in accordance with all federal, state, and local laws, including, but not limited to, the Los Angeles County Fair Chance Ordinance and the California Fair Chance Act.