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Quality manager jobs in New Jersey

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  • Quality Management Specialist II

    Us Tech Solutions 4.4company rating

    Quality manager job in Princeton, NJ

    Duration: 12 months The Quality Management Specialist II tasks include: CW shadows 3 ongoing studies and supports 7 ongoing studies (planning to reporting stage) to provide Quality oversight, to recommend best practices. Communicates and collaborates with the stakeholders (CM and FAs) partnering for cross-functional team support and attendance of project and study level meetings. With the assistance of Senior GCP Level 1 members, consults on major and critical quality issues, potential Serious Breaches, significant noncompliance, data integrity issues and protocol deviations, escalates to Senior Management, and performs periodic resolution checks for assigned studies. Supports risk assessments and risk-based approaches for the annual GQM Audit Plan, identifies the number of site audits and vendor audits based on risk-criteria with input from study teams. Provides study and site related information and documentation to the audit team, GCP Level 2 in preparation for audits. Participates in the risk assessment of preferred and active vendors utilizing risk assessment tools to prepare the annual GQM Vendor Audit Plan. Involved in CAPA review of Quality Issues, Audits, Inspections, eTMF audit responses. Participates and contributes to weekly, monthly, and quarterly GQM GCP meetings. Attends QA:QA and Quality Council meetings with CRO accompanied by a Senior Member from the GCP In-Line Quality (Level 1) Participates in the review and harmonization process of controlled documents such as protocols/ICF, CSRs, amendments, procedural documents & templates. Receives GCP training of ICH Guidelines E6 R3 and Modules from 21CFR and reads GCP Material. Team Members in training participate in weekly team support meetings. Involved in the Portfolio-wide proactive Inspection Readiness support (Sponsor, Site, CRO) - conducts Do & Don't training, participates in interview preparations/debriefs, assesses Inspection Readiness Visits and Pre-Inspection Visits outcomes. Reviews and assesses Pharmacovigilance System Master File (PSMF) and performs PV related activities as assigned. Qualifications: Bachelors Degree; preferably some Pharmaceutical background and GCP ICH E6 knowledge. About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit ************************ US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Recruiter Details: Name: Vicky Email: ********************************** Internal Id: 25-54443
    $49k-76k yearly est. 3d ago
  • Quality Assurance Manager

    Hikma Pharmaceuticals 4.9company rating

    Quality manager job in Cherry Hill, NJ

    JOB PURPOSE : Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that materials and products are inspected and released in compliance with cGMP guidelines, USP and FDA, EU requirements. Responsible for first shift QA In-Process and In-coming Groups, getting all the QA batch record documents approved for timely release of finished products and timely release of incoming materials. Work closely with Operations (Filling and Packaging) and other groups as necessary to troubleshoot issues in the warehouse, filling and packaging floors and ensure timely reporting of events. Work closely with compliance group at times of external audits (FDA or vendors). Ensure that non-compliant situations are thoroughly investigated. KEY ACCOUNTABILITIES: Regular and predictable onsite attendance and punctuality. Directs the incoming and in-process QA groups. Makes final accept/reject disposition on incoming materials, including but not limited to raw materials, components, production commodities. Assures batch is manufactured Ensures that records are reviewed and released in a timely manner. Coordinates communication for status of incoming materials and resolves issues related to accept/reject disposition of materials. Coordinates communication of production status to next shift; attends daily update meetings as required. Manages personnel for in-process filling and inspection/packaging monitoring. Provides QA review and approval of manufacturing investigations, as necessary, assuring timely review, follow-up, tracking and trending of MIRs. Provide guidance to the investigator, as required Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR's, Commissioning Documents, FAT's), engineering documents. Expedites and prioritizes product releases by coordinating the Review of QA documentation to meet customer service requirements. Conducts routine investigation and departmental meetings to facilitate the performance of release function, with respect to incoming materials. Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff. Places lots on HOLD if Quality issues are detected and notifies senior management. Assists the QA management in developing on department budget. Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions. Manages attendance records for all direct reports. QUALIFICATIONS: College Degree within a science related discipline such as a B.S. in Pharmacy, Science, Engineering or other related fields is required with 10+ years' experience, or Masters' Degree in Microbiology, or biological science with 3-6 years' experience Ph.D. in relevant field with 0-3 years' experience Preferred: Additional college courses in Microbiology, cGMPs, Statistics or Quality Management are beneficial EXPERIENCE: Minimum: Experience in the Pharmaceutical Industry in the field of Quality Assurance or Production is a must SKILLS: Must have history of strong documentation skills and attention to detail Familiarity with cGMPs and CFR for US and EU Excellent organizational skills and ability to multi-task and perform work in a timely manner Demonstrates ability to lead a department, projects and meetings effectively Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management General computer skills and ability to prepare presentations and address large groups Demonstrated attention to details and accuracy The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must Mentoring abilities as well as effective communication, (written and oral) are required. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.
    $75k-105k yearly est. 4d ago
  • Quality Specialist

    Intellectt Inc.

    Quality manager job in Vineland, NJ

    ⏳ Duration: 12+ Months Contract We are seeking an experienced Quality Specialist to ensure products and manufacturing processes meet established quality, compliance, and efficiency standards. This role plays a critical part in root cause analysis, corrective action implementation, supplier quality management, and continuous process improvement within a manufacturing environment. Key Responsibilities Ensure products and services meet defined quality, regulatory, and efficiency standards through robust quality assurance and quality control processes Lead and participate in cross-functional teams to perform root cause analysis and implement permanent corrective actions Prepare and maintain customer-required quality documentation, including A3 and 8D reports Develop and execute compliance and quality plans using established quality engineering methodologies and standards Understand, implement, and maintain Product Quality Plans (PQP/APQP) Conduct regular internal and supplier quality audits to ensure ongoing compliance with company and industry standards Identify opportunities for continuous improvement within production and testing processes Maintain detailed supplier quality metrics, including defect rates, FAI documentation, and specification compliance Required Qualifications Bachelor's degree in Engineering or related discipline 3+ years of experience in Quality Engineering or Process Engineering within a manufacturing environment Strong knowledge of quality control standards, methodologies, and statistical analysis tools Hands-on experience with manufacturing and production processes
    $57k-90k yearly est. 1d ago
  • Quality Control Stability Supervisor

    Veranova

    Quality manager job in West Deptford, NJ

    Discover Veranova: At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference. Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation. Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients. Role Overview: The Stability Supervisor plays a key role in ensuring our stability program is executed accurately, safely, and in full compliance with internal and regulatory standards. This role supports the QC Manager in driving departmental goals, fostering a culture of continuous improvement, and developing team capabilities. It's an opportunity to make a meaningful impact on quality, reliability, and operational excellence. Core Responsibilities: Assign daily tasks to the stability chemists to meet stability testing schedule. Test stability samples as needed. Maintain safety and quality systems in a state of audit readiness. Works with cross-functional teams (production, quality assurance, regulatory, commercial, project management, etc.) to support product campaigns defining stability requirements. Leads laboratory investigations, identifying root causes and enacting effective CAPAs to improve overall laboratory performance (%RFT). Develops direct reporting chemists through goal setting, performance management with regular review (i.e. 1 on1 meetings). Reviews analytical data as required and writes necessary reports this includes stability summary reports. Executes safety initiatives in the laboratory the maintain and improve work environment. Updates relevant SOPs along with evaluation of current and new equipment or use in the laboratory. Involved with laboratory audits through laboratory walkthroughs responding to auditor request/questions. Implements and applies cGMP concepts in association with department specific responsibilities. Helps QC Manager develop yearly budget and CAPEX plan to support future lab equipment and resource needs. Qualifications: Required Bachelor's degree in chemistry or related science Minimum of 5 years cGMP laboratory experience Minimum of 3 years stability program experience Ability to communicate effectively with impact internally and externally Builds collaborative relationships cross-departmentally Seeks opportunities for continuous improvement Able to make decisions after evaluating current laboratory workload Adaptability due to changing production demands due to customer needs Preferred Proficiency in standard QC laboratory equipment (HPLC, GC, FTIR, UV, KF, etc.) Adept at report writing and root cause analysis Background in data trending Supervisory experience/leading teams Salary Range : $90,000 - $100,000 annual base salary Our Commitment: Health & Wellness: Comprehensive health & wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies. Financial Wellness: Veranova is committed to fair and transparent compensation practices. This includes a competitive base salary, eligibility for performance-based bonuses, and an attractive 401(k) Plan with company match. Salary ranges reflect the scope and expectations of the role, and are based on market data, internal equity, and role-specific factors. Final compensation may vary depending on experience, skills, education, and business needs. Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs. Inclusive Culture: At Veranova, an inclusive culture is integral to our values. We welcome people with diverse experiences and perspectives who share our mission to improve and save lives. Even if you don't meet every qualification, we encourage you to apply. Veterans, first responders, and those transitioning from military to civilian life bring valuable skills that strengthen our team. Additional Information: Applicants for this role must be authorized to work in the United States without further employer sponsorship. Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting. All your information will be kept confidential according to EEO guidelines. Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law. All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice .
    $90k-100k yearly 1d ago
  • Repair Quality Engineer

    Hanwha Vision America 4.1company rating

    Quality manager job in Englewood, NJ

    Hanwha Vision America (HVA) is an affiliate of the Hanwha Group, a Fortune Global 500 company. HVA is an industry-leading provider of advanced network video surveillance products, including IP cameras, storage devices, and video management systems, founded on world-class technologies. We offer end-to-end security solutions and have achieved global success across a wide range of industry verticals, including retail, transportation, education, banking, healthcare, hospitality, and airports. Hanwha Vision America (HVA) is seeking a Repair/ Quality Engineer to support HTCC's engineering and repair operations by performing intake screening, basic diagnostics, quality checks, and documentation. The role ensures that incoming units are properly evaluated, repair processes run efficiently, and completed products meet quality standards before shipment. This position combines repair-support responsibilities with quality assurance activities to improve workflow efficiency, accuracy, and overall service performance. Major Functions / Accountabilities Perform initial screening and basic functional checks on incoming units Identify obvious issues or simple conditions that can be resolved before repair Support repair workflow by preparing units, organizing information, and performing basic diagnostics Conduct quality checks on completed repair units to ensure they meet internal standards Document inspection results and update system records accurately Assist with failure analysis for repeated issues and provide feedback to engineering Inspect packaging quality and verify final shipment readiness Collaborate with repair staff, engineering, logistics, and warehouse teams as needed Maintain checklists, guidelines, and standard procedures for inspection work Support process improvements related to efficiency, quality, and documentation compliance Knowledge, Skills & Requirements Preferred background: Electronics, Electrical Engineering, Computer Engineering, or related field Basic understanding of electronic components (e.g., resistors, capacitors, diodes) Ability to use multimeters and basic diagnostic tools Strong attention to detail and problem-solving skills Ability to follow technical checklists and standardized procedures Proficiency with Microsoft Office and basic system data entry Bilingual (Korean/English) preferred but not required
    $71k-98k yearly est. 3d ago
  • Food Safety Quality Assurance Manager

    Schweid & Sons 4.0company rating

    Quality manager job in Carlstadt, NJ

    Schweid & Sons is a family-owned and operated premium ground beef company with a proud heritage spanning four generations. We supply top-quality beef to Retail, Foodservice, and National Account customers across the U.S. and are committed to quality, customer service, and innovation in protein manufacturing. Summary: This is a leadership role within the organization that is responsible for a broad range of processes, products, and team members over 2 shifts of production as well as the relationship with FSIS and 3 rd party sanitation. Essential Job Functions: Food Safety / Regulatory Managing implementation of the HACCP Plan, its associated documents and including reassessments Maintaining records in accordance to the policy / HACCP program Conduct plant GMP inspections and monitor GMP's for compliance Responsible for maintaining the company's compliance with FSIS regulations. Ensure compliance with established policies and procedures such as HACCP, GMP's, SSOP, CAPA, and hold and release of products. Oversee training program for GMP's, HACCP and Food Defense/Food Fraud. Respond to non-compliance reports issued by FSIS. Manage the 3 rd party Sanitation program for the facility. Quality / Customer Service Lead 3 rd party audits (SQF / Customer Specific) and Customer tours including CAPA's. Strive for continuous improvements of products, process, procedures, and reliability. Maintain data of customer requirements, quality specifications and reporting requirements. Manage quality training program. Ensure specification compliance for raw materials and finished products. Managing implementation of quality programs. Assist with product development and special projects associated with product development. Respond to customer complaints with CAPA's / letters as needed. Establish the raw material and finished product shelf life. Other Contributing to a Safety Culture Manage FSQA Department (Techs, Sanitations, Supervisors) including exempt and non-exempt labor Manage the department to meet budget. Other tasks and projects may be assigned. 10 - 20% travel required Minimum Requirements: Red Meat Experience a Must Bachelor of Science in Food Technology, Food Process Engineering, or related field; MS preferred. 5 plus years' experience working in the Food Industry in a leadership role. HACCP Knowledge and Experience SQF / BRC Knowledge and Experience Ability to think independently and take responsibility for decisions. What We Offer The expected compensation for this role is $100,000 - $130,000 per year, depending on experience and qualifications. Final compensation will be discussed during the interview process. Time Off: PTO, Safe & Sick Time, and Paid Holidays. Health Benefits: Medical, vision, dental, HRA and voluntary disability benefits. Financial Benefits: 401(k) + employer match and life insurance. Location: This is an on-site role located in Carlstadt, NJ. Environment: Our facility is refrigerated. In this role you will be exposed to < 40 degrees for multiple hours of the day.
    $100k-130k yearly Auto-Apply 57d ago
  • SAP Quality Management/Manufacturing Manager - Chemicals Industry

    Accenture 4.7company rating

    Quality manager job in Morristown, NJ

    We Are: Are you ready to step into the heart of digital transformation in one of the world's most critical - and most dynamic - industries? The Chemicals Industry is evolving at lightspeed: demand for sustainability-driven products is on the rise. At the same time, digital platforms, real-time analytics, AI, and SAP-enabled processes are no longer "nice to have" - they are foundational. As part of Accenture's SAP Chemical's Practice, you'll be delivering major SAP engagements (for example, Business Transformation Strategy & Roadmaps, migrations to SAP S/4HANA, process standardization, cloud-enablement) that help clients win in this new environment and guide major Chemical clients through the journey of business-model reinvention, process excellence and enterprise technology enablement You Are: Do you have a passion for storytelling and for originating, selling and delivering SAP-based Supply Chain Transformation projects that make a positive impact in your clients' business? Are you inspired by working with the best companies in their industries? Want a role that provides you with a sense of purpose and satisfaction? Then join Accenture and build a rewarding career improving the way the world works and lives, as you help clients innovate with leading-edge SAP and Accenture Supply Chain solutions and technologies on some of the most innovative projects in the world You will thrive in our highly collaborative, digitally-driven and innovation-led environment while nurturing your talent for thoughtful and game changing solutions in our inclusive culture that values diversity of ideas, experiences and backgrounds. Ultimately, you are a confident manager who spots and stays ahead of the SAP platform, industry and Supply Chain trends and knows how to translate client goals into clear and actionable outcomes that everyone can get behind. You know how to fully utilize the capabilities of various SAP platforms to drive business value, transform end-to-end functions and drive leading practices for your clients in markets all over the globe. The more complex their challenges, the more excited you are about leading the charge to solve them. The Work: Team with clients on their SAP functional transformation programs through your combined SAP application and functional process expertise which includes your ability to: + Engage with client executives on the business challenges/trends and the potential value of SAP solutions (current & future) + Lead customers in defining their SAP journey through the development of business cases & roadmaps including during sales origination, proposal development and client presentations + Architect E2E solutions that leverage SAP technologies, custom apps, & add on partner solutions + Advise, design and deliver solutions based on the latest industry and technology best practices leveraging a SAP solutions and embedded innovation. + Lead small teams - helping them achieve transformational roadmaps - onsite with clients or within Accenture + Become a trusted expert and advisor to your clients, team, and Accenture Leadership by staying current on regulations, trends, and innovations across your area of expertise + Be a thought leader, build assets and best practices and develop the next level of transformation experts Travel may be required for this role. The amount of travel will vary from 0 to 100% depending on business need and client requirements Here's what you need: + Minimum of 5 years of SAP functional and technical experience/expertise in Quality Management and/or Manufacturing. + Minimum 3 years of experience in SAP projects supporting Chemicals clients. (SAP support / managed services experience will not be considered for this requirement) + Minimum 2 end-to-end SAP S/4 implementations, including project planning, estimation and solution architecture for Chemicals clients + Experience managing SAP delivery teams, in a Global Delivery Model, including but not limited to the following responsibilities: driving complex workshops and leading design decisions, as well as leading the design and execution of system build, configuration, testing, cutover, and go-live in the SAP Transportation Management or Quality Management area + Prior experience in a Consulting and/or Advisory role + Bachelor's degree or equivalent (minimum 12 years' work experience). If Associate's Degree, must have equivalent minimum 6-year work experience Compensation at Accenture varies depending on a wide array of factors, which may include but are not limited to the specific office location, role, skill set, and level of experience. As required by local law, Accenture provides a reasonable range of compensation for roles that may be hired as set forth below. We accept applications on an on-going basis and there is no fixed deadline to apply. Information on benefits is here. (************************************************************ Role Location Annual Salary Range California $94,400 to $293,800 Cleveland $87,400 to $235,000 Colorado $94,400 to $253,800 District of Columbia $100,500 to $270,300 Illinois $87,400 to $253,800 Maryland $94,400 to $253,800 Massachusetts $94,400 to $270,300 Minnesota $94,400 to $253,800 New York/New Jersey $87,400 to $293,800 Washington $100,500 to $270,300 Requesting an Accommodation Accenture is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Accenture and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired. If you would like to be considered for employment opportunities with Accenture and have accommodation needs such as for a disability or religious observance, please call us toll free at **************** or send us an email or speak with your recruiter. Equal Employment Opportunity Statement We believe that no one should be discriminated against because of their differences. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. For details, view a copy of the Accenture Equal Opportunity Statement (******************************************************************************************************************************************** Accenture is an EEO and Affirmative Action Employer of Veterans/Individuals with Disabilities. Accenture is committed to providing veteran employment opportunities to our service men and women. Other Employment Statements Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States. Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration. Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process. Further, at Accenture a criminal conviction history is not an absolute bar to employment. The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. Additionally, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the Company's legal duty to furnish information. California requires additional notifications for applicants and employees. If you are a California resident, live in or plan to work from Los Angeles County upon being hired for this position, please click here for additional important information. Please read Accenture's Recruiting and Hiring Statement for more information on how we process your data during the Recruiting and Hiring process.
    $100.5k-270.3k yearly 30d ago
  • Director, Clinical Quality Assurance

    Eisai 4.8company rating

    Quality manager job in Nutley, NJ

    At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH). Essential Functions · Independently conduct audits · Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits · Facilitate Sponsor health authority inspections of global clinical facilities and study sites · Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs · Direct skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies. · May be responsible for direct people management including goal setting, performance management, development, and engagement. Requirements · Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area. · 5+ years of experience in GCP auditing. · Substantial experience in inspection management. · Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials. · Demonstrated ability to operate and influence decision-making processes · Effective communication skills · Successful track record of supervising employees and managing cross-cultural differences · Technical and administrative capabilities to independently carry out routine, complex and for-cause audits · Knowledge of data integrity controls and systems quality for clinical area · Strong analytical skills and report writing skills · Experience with GxP systems including computer system validation and associated regulations, recommended. · Ability to Travel (approximately 20%) · Candidates near Eisai's NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities. Eisai Salary Transparency Language: The base salary range for the Director, Clinical Quality Assurance is from :195,000-256,000Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit *********************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation
    $109k-151k yearly est. Auto-Apply 60d+ ago
  • Quality Control Laboratory Manager

    Rocketpharma

    Quality manager job in Cranbury, NJ

    Create a future where DNA is no longer destiny. Join Rocket Pharma. Rocket Pharma is a fully integrated, late-stage biotechnology company advancing gene therapies with curative potential for patients with rare and life-threatening diseases. We are a team of creative, compassionate, and driven individuals united by a profound mission of seeking gene therapy cures. Rocket places tremendous value on our people and fosters a collaborative environment where bold ideas thrive and every team member makes a meaningful impact. Our core values guide everything we do: we trust one another, show generosity toward patients, embrace curiosity, and strive to elevate science. Team members receive a competitive total rewards package, including equity participation, 401(k) matching, and excellent health benefits. Position Summary This Quality Control (QC) Laboratory Manager role is a scientific based position that involves reviewing and analyzing test results as well as overseeing daily lab operations. You will be a key team member responsible for keeping QC operations running in an efficient and productive state. This role interacts with the lab technicians, management, EHS, Facilities, and QA to ensure strict adherence to procedures with a continuous improvement mindset. The ideal candidate will be extremely organized, have a strong analytical operations background, and have a strong passion and curiosity for science and gene therapy. Responsibilities Managing Lab Technician(s) overseeing sample management (receipt, storage, distribution, and disposal) and stocking of lab consumables and reagents Scheduling assays through Electronic Scheduling System for QC and preparing all necessary materials and controlled worksheets and protocols/methods for the scientists to execute the assays Supporting Management by performing peer reviews of testing data Supporting Method Performance tracking and trending through data entry, verification, and record archival Establishing and maintaining training curriculum for the lab scientists and supporting scheduling for cross-training of analysts Maintaining control and inventory of critical reagents, Reference Standards, Retains/Reserves, etc. Operations tracking including Assay Results, Invalid Assays, and Equipment cleaning, maintenance, and calibration Tracking on time closure of QC Quality records including Deviations, Invalid Assays, OOS and CAPAs and reporting of Metrics upwards to QC/QA management Support revision of SOPs and forms to improve workflows in QC Overseeing Housekeeping activities of lab areas Verifying Logbooks are reviewed on time Tracking Lab Notebooks lifecycle Working with EHS to improve Safety Culture in QC Qualifications M.S. in Biology, Molecular biology, or Immunology with 4+ years of relevant experience or BS in Biology, Molecular Biology, or Immunology with 6+ years of relevant experience or equivalent experience in the biotechnology industry. Ability to be onsite 5 days per week Deep understanding and experience with working in a GMP environment Experience with dd PCR, ELISA, Flow-cytometry, UPLC and/or cell-based assays Ability to work independently and make decisions Leadership experience and project management skills to support a multi-project environment in small biotech. Physical Requirements: Constantly works in a GMP lab environment with analytical instruments, reagents and cleaning materials Cleaning with biohazard materials and chemical solutions including bleach and Spor-Klenz Constantly wears proper PPE including lab coat, safety glasses and chemical resistant gloves Must be able to remain in a stationary position for 50% of the time Must be able to detect and distinguish primary colors (red, yellow, and blue) and secondary colors (green, orange, and purple) as they appear on process equipment digital displays and computer screens Constantly communicates verbally with people to exchange information, and give and receive instructions Frequently positions self to set-up, operate, clean, and maintain process equipment and handle materials Compensation The expected salary range for this position is $122,000 to $144,000. At Rocket, our compensation philosophy and ranges are built upon data and insights collected from validated world-class providers. We are committed to compensating employees equitably based on several factors, including responsibilities and level of the position, depth and types of the employee's experience, location of the position and availability of similar talent in a competitive market. For U.S.-based candidates, this is an at-will position, and Rocket reserves the right to adjust the range at hire or during the year due to market shifts. In addition to base salary, Rocket offers a competitive total rewards package that may include bonuses (short-term incentives), medical, dental, and vision insurance, life insurance, 401(k) with company match and generous vesting, paid vacation and holidays, global shutdown days between Christmas and New Year's, and a variety of wellness resources and employee support programs. Also, certain positions are eligible for added forms of compensation, such equity awards (long-term incentives). EEO Statement A diverse workforce fosters innovation and strengthens Rocket's business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.
    $122k-144k yearly Auto-Apply 38d ago
  • Quality Control Manager

    Veranova L P

    Quality manager job in West Deptford, NJ

    Discover Veranova: At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference. Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation. Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients. Role Overview: The QC Manager is responsible for the management of all quality control testing of raw materials, intermediates and final products (including stability testing) at the West Deptford site. This includes test methodology and documentation required for quality control within government, customer and industrial specifications. The incumbent works closely with quality assurance to ensure that products meet and/or exceed applicable FDA and cGMP standards. This position also works closely with development, production and with customers to ensure that all products meet required specifications. Core Responsibilities: Manage the resources of the Quality Control functions, cGMP systems to ensure products are consistently manufactured and tested according to the cGMP standards. Provides appropriate coaching and performance feedback to all direct reports and assures that all team members are being developed. Manages staff in full compliance with cGMP requirements. Responsible for the Quality Control Department budget and its control. Maintain active customer and governmental contacts concerning technical problems and product compliance and performance. Manages compliance with state and federal regulations, including but not limited to EPA, DEP, and OSHA, etc. Assure all testing procedures are written, validated, and maintained. Monitor and direct all quality control activities, which includes but is not limit too, staff scheduling, prioritization of department's work, product team participation, and determination of projects as needed for continuous improvement. Leads quality control investigations and determines root cause to provide effective resolutions, such as CAPA's. Responsible for the overall release/results of materials from the lab. Evaluates metrics to develop/implement efficiency improvements. May perform all work associated with Quality Control Chemist duties to meet the department needs. Qualifications: BS Chemistry or related science Minimum of ten (10) years' direct experience in organic analytical/instrumentation chemistry Minimum of seven (7) years direct experience in organic analytical/instrumentation chemistry lab supervision. Preferred Chromatography background Salary Range: $120,000 - $145,000 annual base salary Our Commitment: Health & Wellness: Comprehensive health & Wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies. Financial Wellness: Veranova is committed to fair and transparent compensation practices. This includes a competitive base salary, eligibility for performance-based bonuses, and an attractive 401(k) Plan with company match. Salary ranges reflect the scope and expectations of the role, and are based on market data, internal equity, and role-specific factors. Final compensation may vary depending on experience, skills, education, and business needs. Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs. Inclusive Culture: At Veranova, an inclusive culture is integral to our values. We are committed to ensuring that everyone can bring their full self to work and thrive in their career. How to Apply: At Veranova, we are on a misson to meet people that believe in our values and can contribute to the team in a variety of ways. Please visit **************** to view all open roles and join our Talent Community to stay connected and learn about opportunities as they arise. We value a range of experiences and perspectives. If you want to be part of improving and saving the lives of patients, we encourage you to apply regardless of whether you meet every qualification listed. Additional Information: Applicants for this role must be authorized to work in the United States without further employer sponsorship. Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting. All your information will be kept confidential according to EEO guidelines. Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law. All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.
    $120k-145k yearly Auto-Apply 60d+ ago
  • Quality Manager - Supplier ODA Focal

    Thyssenkrupp Materials

    Quality manager job in Plainfield, NJ

    Job SummaryDirect, lead and supervise the development of a total quality environment with an emphasis on unexcelled customer satisfaction and continual quality improvement. Accomplish quality-related objectives using quality meetings, planning, training, statistics, and internal/external audits. Ensure that processes and products are in compliance with the current Quality Management System requirements and applicable regulatory obligations. Serve as the designated authority for regulatory programs (e.g., ODA), maintaining compliance with external agency expectations while aligning with company quality standards.Job Description Key Accountabilities: •Direct and coordinate all aspects of Quality Management, including ISO/AS/TS compliance, quality improvement initiatives (CQIB), and customer satisfaction strategies to support company goals and objectives. •Report on the suitability and effectiveness of the Quality Assurance System while fostering a strong quality culture across all branches through leadership collaboration and communication. •Partner with department managers to establish goals, assess competencies, and guide quality outputs in alignment with corporate Quality Objectives. •Maintain frequent communication with site Quality Assurance Representatives to ensure consistency, effectiveness, and alignment across regions. •Lead and oversee quality assurance functions, including planning, statistical process controls, corrective/preventive action systems (CPAR), customer/vendor claims, trend analysis, and documentation of customer quality requirements. •Direct internal and external audits, provide technical assistance, root cause/corrective action process, manage quality non-conformance and drive employee training and development in quality, regulatory compliance, LEAN, and safety. •Support overall ODA program activities as required, including maintaining Unit Member records, coordinating application reviews and evaluation panels, tracking required FAA training, and assisting with annual evaluations and related correspondence. •Assist in developing, revising, and maintaining ODA quality manuals and procedures in collaboration with ODA representatives and stakeholders, ensuring alignment with FAA policies and identifying process or training impacts from regulatory updates. •Contribute to planning and execution of ODA and FAA audits, including preparing audit materials and reports, coordinating timely closure of corrective actions, and ensuring accurate tracking and reporting of ODA/FAA-required metrics and quarterly submissions. •Provide leadership and direct supervision to quality department teams across multiple functions, ensuring alignment with organizational goals. •Report directly to the Plant Manager and indirectly to Corporate Regulatory/Trade Compliance leadership to drive corporate quality, standardization, and safety initiatives. •Participate, support, and comply with all health, safety, quality, ISO and 6S Initiatives, compliance and Lean initiatives, requirements, and/or trainings. •Ability to access and work in SAP or other Warehouse Management System •Provide leadership and direct supervision to quality department teams across multiple functions, ensuring alignment with organizational goals. •Report directly to the Plant Manager and indirectly to Corporate Regulatory/Trade Compliance leadership to drive corporate quality, standardization, and safety initiatives. •Participate, support, and comply with all health, safety, quality, ISO and 6S Initiatives, compliance and Lean initiatives, requirements, and/or trainings. •Ability to access and work in SAP or other Warehouse Management System The above is intended to describe the general content of and requirement for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements. Meet all other TKMNA employee attributes and competencies Qualifications: Minimum Requirements: This position requires access to export-controlled technical data or technology. Employment is contingent upon obtaining any required export authorization from the appropriate government agency or agencies. When export authorization is necessary, the length of time to obtain the authorization by the government is outside of the Company's control. •Bachelor's degree/ 3+ years management experience/ leadership/team building/training in Quality Assurance/Control. •ODA Certification/industry credential & knowledge of ODA programs, FAA regulations, or aerospace regulatory compliance. •3+ years relevant experience working as a supplier ODA Focal or Unit Member in an aerospace or any equivalent industry. •Experience in TQM, ISO/QS 9000 ISO Assessor Certification, SPC. •Demonstrated proficiency in Microsoft Word, Excel, and PowerPoint, with strong verbal, written, and interpersonal communication skills. •Demonstrates dedication to delivering high-quality customer service while being positive, detail-oriented, organized, team-oriented, and a proactive problem-solver capable of multitasking and prioritizing in a fast-paced, deadline-driven environment. Preferred Requirements: •ASQ certification •ISO Lead Assessor Certification •5 years plus Quality Assurance/Control •3+ years of experience as an FAA ODA Unit Member or Supplier ODA Focal, with working knowledge of FAA rules, regulations, ODA programs, and aerospace regulatory compliance (or equivalent industry experience). •Training in strategic planning and motivation Benefits Overview We offer competitive company benefits to eligible positions, such as : Medical, Dental, Vision Insurance Life Insurance and Disability Voluntary Wellness Programs 401(k) and RRSP programs with Company Match Paid Vacation and Holidays Tuition Reimbursement And more! Benefits may vary based on job, country, union role, and/or company segment. Please work with your recruiter or tk representative for applicable benefits information. Disclaimer This is to notify the general public that some individuals/entities are using the thyssenkrupp (“TK”) name, trademark, domain name, and logo without authorization. They are posing as employees, representatives, or agents of TK and its associated/group companies. These individuals/entities are fraudulently offering jobs online through texts, websites, telephone calls, emails, or by issuing fake offer letters. They are also soliciting jobseekers to deposit money in certain bank accounts or providing jobseekers with fraudulent checks to obtain banking information. TK does not ask, solicit, or accept any monies in any form from candidates, job applicants, or potential jobseekers, who have applied to or wish to apply to TK, whether online or otherwise as a pre-employment requirement. TK bears no responsibility for money being deposited/withdrawn therefrom in response to such fake offers. TK does not: 1. Send job offers from free email services like Gmail, Rediffmail, Yahoo mail, etc.; 2. Request payment of any kind from prospective jobseekers or candidates for employment; 3. Authorize anyone to collect money or agree to any monetary arrangement in return for a job at TK; 4. Send checks to job seekers; or 5. Make job offers through third parties. In the event TK uses professional recruitment services through a third party, offers are always made directly by TK and not by any third parties. PLEASE NOTE: 1. TK strongly recommends that potential jobseekers do not respond to such fake solicitations, in any manner; 2. TK will not be responsible to anyone acting on an employment offer that is not directly made by TK; 3. Anyone making an employment offer in return for money is not authorized by TK; and 4. TK reserves the right to take legal action, including criminal action, against such individuals/entities. TK follows a formal recruitment process through its own HR department and applications are evaluated by its HR department through pre-defined processes. Please visit our official careers website at ******************************** to view authentic job openings at TK. If you receive any unauthorized, suspicious, or fraudulent offers or interview calls, please email us at **********************************************. We shall not accept any liability towards the representation made in any fraudulent communication or its consequences, and such fraudulent communication shall not be treated as any kind of offer or representation by TK or its group companies and affiliates.
    $87k-120k yearly est. Auto-Apply 60d+ ago
  • Quality Control Manager

    Atrium Staffing

    Quality manager job in Princeton, NJ

    Our client is a fast-growing personal care and cosmetics manufacturer known for innovation, high standards of product excellence, and a passionate consumer base. They are now looking for a Quality Control Manager. Salary/Hourly Rate: $90k - $115k The Quality Control Manager will lead product-focused quality control operations to ensure all finished goods meet established specifications, regulatory requirements, and internal quality standards. This role is integral in overseeing product release, managing QC laboratory functions, supporting investigations, and driving continuous improvement initiatives. The Quality Control Manager will supervise a team of 2-3 specialists and serve as a key partner to the Quality Director in strengthening quality systems, documentation, and operational readiness. Expected travel is approximately 30% to contract manufacturers nationwide. Responsibilities of the Quality Control Manager: * Oversee the complete product release process, including incoming inspection, analytical testing, disposition, and management of nonconformances. * Review and approve deviations, investigations, and CAPA documentation to ensure effective root-cause analysis and corrective actions. * Collaborate cross-functionally to support new formulation launches and ensure quality requirements, inspection criteria, and testing protocols are implemented. * Manage QC laboratory operations, including equipment oversight, instrument calibration, cleanliness, and safety compliance. * Supervise the retain program and maintain product master standards. * Evaluate consumer complaint samples and support quality trend analysis. * Administer and enhance the Quality Management System (QMS), including SOPs, CAPAs, audits, inspections, and documentation. * Develop and deliver training related to cGMP, quality systems, and technical processes. * Provide leadership, coaching, and performance feedback to QC Specialists. * Monitor, analyze, and report quality KPIs to drive continuous improvement. Required Experience/Skills for the Quality Control Manager: * 5+ years of QC or quality-related experience in personal care, cosmetics, or fragrance manufacturing (required). * Prior supervisory experience with the ability to lead and develop laboratory personnel. * Strong background in nonconformance management, analytical testing, and product release processes. * Experience working within cGMP and ISO 22716 environments. Education Requirements: * Bachelor's degree in a Scientific or Engineering discipline, or equivalent experience. Benefits: * Comprehensive medical, dental, and vision coverage (including HSA with employer contribution). * Paid time off and paid holidays. * 401(k) retirement plan. * Additional competitive benefits.
    $90k-115k yearly 22h ago
  • Manager, Quality Control Physicochemistry

    Beone Medicines

    Quality manager job in Pennington, NJ

    **General Description:** Manages all Quality Control (QC) Physicochemistry laboratory activities to support GMP manufacturing, testing and release of materials, intermediates and finished products under FDA/EU regulations, applicable International Regulations, BeOne processes and procedures. Establishes and implements QC Physicochemistry procedures and supports regulatory compliance inspections. Ensures efficient and effective day to day operations of the Physicochemistry laboratory. This position reports to the Senior Manager QC and is located full time at the Hopewell, NJ site. **Essential Functions of the Job:** + Lead the QC Physicochemistry laboratory daily workflow. + Establish and maintain QC Physicochemistry laboratory related quality systems to ensure conformance with regulations and BeOne Global quality standards. + Manage QC Physicochemistry laboratory routine operations, including but not limited to validation, SOPs, specifications, testing records, personnel training and assessment, scheduling, etc. + Ensure Physicochemistry laboratory compliance with Environmental Health and Safety (EHS) standards. + Ensure timely completion of testing (e.g., In-process control, DS release, DP release, and stability testing) to ensure timely generation and reporting of test results in support of manufacturing operations. + Review of laboratory test results, ensuring adherence to Good Documentation Practices. + Ensure appropriate investigation of OOS events, discrepancies, lab errors, and equipment failures. + Implementation of effective corrective actions and preventive actions (CAPAs). + Participate in internal and external GMP audits where possible. + Ensure that the QC Physicochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives. + Expertise in Quality Control (QC) within a Good Manufacturing Practice (GMP) environment, ensuring compliance with industry standards and regulations through hands-on laboratory experience. + Working knowledge and experience with physicochemistry analytical methods such as GC, HPLC, UPLC, IEF, TOC, UV, FTIR, etc. + Knowledgeable with USP/EP and cGMP/EU GMP regulations. + Familiar with instrument and equipment validation. + Expert knowledge of quality control principles, practices and standards for the biopharmaceutical industry. + Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level. + Strong leadership/team management skills and experience. + Manage, motivate, coach and mentor direct reports. + Credible and confident communicator (written and verbal) at all levels. + Strong analytical, problem-solving ability, with excellent attention to detail, with the ability to work accurately in a busy and demanding environment. + Excellent project management skills. + Hands-on approach, with a 'can do' attitude. + Ability to prioritize, demonstrating good time management skills. + Self-motivated, with the ability to work proactively using own initiative. + Committed to learning and development. + Interacts with all levels of BeOne employees + Undertake any other duties as required. **Supervisory Responsibilities:** + Manage direct reports from QC Physicochemistry laboratory. + 2+ years of managerial experience directly managing people required. + Leadership experience leading teams, projects, programs or directing the allocation of resources. **Computer Skills:** + Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint). + Ability to work on a computer for extended periods of time **Travel:** Must be willing to travel approximately 10% **Education/Experience:** + Bachelor of Science degree and 5+ years of experience in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility required. + Bachelor's in Chemistry, Biology, Molecular Biology, Biotechnology, Biochemistry, or related scientific discipline preferred. + Master's degree and 4+ years of relative experience preferred. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
    $69k-103k yearly est. 20d ago
  • Supplier Quality Manager

    Cencora, Inc.

    Quality manager job in Kearny, NJ

    Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details The Supplier Quality Manager is responsible for ensuring suppliers meet World Courier quality standards and compliance requirements while driving continuous improvement in supplier performance. This role involves developing and maintaining supplier quality programs, conducting audits, and managing supplier relationships to ensure the delivery of high-quality materials and services. The Supplier Quality Manager collaborates across departments to align supplier performance with organizational goals and regulatory standards. Primary Duties and Responsibilities: Supplier Quality Program Development * Develop and implement supplier quality management policies, procedures, and standards. * Partner with global QA to establish and maintain supplier qualification and approval processes. * Define key performance indicators (KPIs) to monitor supplier quality and performance. Supplier Audits and Assessments * Conduct regular supplier audits to ensure compliance with quality standards, regulatory requirements, and company specifications. * Perform risk assessments for suppliers and identify opportunities for improvement. * Prepare audit reports, corrective actions, and follow-up plans for supplier quality issues. Supplier Relationship Management * Build strong relationships with suppliers to foster collaboration and alignment. * Communicate quality expectations clearly and provide feedback to suppliers on performance. * Work closely with suppliers to implement corrective actions and resolve quality issues. Quality Issue Resolution * Investigate supplier-related quality issues and implement root cause analysis to prevent recurrence. * Collaborate with internal teams to address and resolve supplier-related challenges. * Ensure timely resolution of non-conformance reports (CAPA) and deviations. Compliance and Regulatory Standards * Ensure suppliers comply with industry standards, regulatory requirements, and certifications (e.g., TSA, GDP). * Maintain supplier quality documentation in accordance with company and regulatory standards. * Stay updated on changing regulations and ensure supplier compliance. Continuous Improvement Initiatives * Drive continuous improvement efforts across the supplier base to enhance quality, efficiency, and cost-effectiveness. * Partner with internal supplier management teams to reduce lead time and improve operational efficiency. * Implement best practices for supplier quality management. Required Qualifications: * Bachelor's degree in Engineering, Quality Management, Supply Chain Management, or a related field. * Minimum of 5 years of experience in supplier quality management, quality assurance, or a similar role. * Strong knowledge of quality management systems (e.g., ISO 9001, GDP). * Experience with supplier audits, corrective actions, and root cause analysis. * Proficiency in quality tools and methodologies (e.g., Six Sigma, Lean Manufacturing, FMEA, SPC). * Knowledge of regulatory requirements such as FDA, EMA, or other relevant standards. Skills and Competencies: * Excellent analytical and problem-solving skills. * Strong project management and organizational abilities. * Effective communication and interpersonal skills to collaborate with suppliers and cross-functional teams. * Ability to negotiate and influence supplier performance. * Proficient in quality management software and tools. Preferred Qualifications: * Certifications such as ASQ Certified Quality Engineer (CQE), Six Sigma Green/Black Belt, or similar. * Experience in pharmaceutical, medical device, or highly regulated industries. * Familiarity with ERP systems and supply chain management software. Work Environment: * Office-based with occasional travel to supplier facilities (estimated travel time 40%). * Must be able to travel overseas if required. * Requires working in cross-functional teams and engaging with suppliers globally. * Having a high sense of dedication and collaboration to support quality department's initiatives and moving quality excellence forward. * Detailed, well-organized and able to multi-task and manage multiple projects at the same time, prioritizing required actions accordingly to meet required deadlines. * Strong drive to remain focused, self-motivated and committed to completing or achieving tasks. * Be open minded to industry/organizations change and learn/adopt new skills/knowledge/tools to drive success. * Excellent skills in Microsoft Office (Excel, Word and PowerPoint). * Able to work independently and lead a team when required. What Cencora offers We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit ************************************** Full time Salary Range* $57,900 - 85,360 * This Salary Range reflects a National Average for this job. The actual range may vary based on your locale. Ranges in Colorado/California/Washington/New York/Hawaii/Vermont/Minnesota/Massachusetts/Illinois State-specific locations may be up to 10% lower than the minimum salary range, and 12% higher than the maximum salary range. Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call ************ or email ****************. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned . Affiliated Companies: Affiliated Companies: World Courier Inc
    $57.9k-85.4k yearly Auto-Apply 2d ago
  • Supplier Quality Manager

    Lancesoft 4.5company rating

    Quality manager job in Raritan, NJ

    OVERALL RESPONSIBILITIES: Customer Quality member responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. These activities include intake, investigation, documentation, follow-up, regulatory reporting and metrics. The Customer Quality Specialist is responsible for the oversight and direct support of technical evaluations and investigational tasks required for complaint processing/closure. The Customer Quality Specialist works collaboratively with Quality, Engineering, Manufacturing, Product Development and other functional experts. DUTIES: • Responsible and accountable for on-time submission and accuracy of regulatory reports • Review and complete determination associated Medical Device Report and/or Vigilance Report • Knowledge of and familiarity with global regulations for reporting • Directly interface with service centers, Hospitals, Surgeons, and Internal employees for reporting of complaints and adverse events • Interact positively with internal, external business partners and colleagues • Adhere and comply to work instructions, standard operating procedures, and regulations • Expedite investigations by collaborating with internal/external business partners • Achieve productivity targets • Fully trained within three months of hire • Achieve accuracy targets for complaint documentations • Participate in projects and events • Complaint determination • Reportability assessments • Conduct follow-ups with complainant, reporters • Checking your own work • Updating SharePoint • Tracking complaints in the process for closure • All other duties as assigned Qualifications • Bachelor's Degree or equivalent experience • Generally requires 2-4 years of related work experience • RAC or ASQ certifications a plus Additional Information All your information will be kept confidential according to EEO guidelines.
    $88k-111k yearly est. 2h ago
  • QC Manager, Training & Compliance

    Lynkx Staffing LLC

    Quality manager job in Saddle Brook, NJ

    Quality Control Manager, Training & ComplianceAllendale, NJ The Quality Control (QC) Manager, Training and Compliance will manage the training and compliance programs across the analytical and microbiological laboratories. This role will ensure that there is a robust training program for the analytical and microbiological laboratories. In addition, this role will manage compliance activities within the laboratory such as deviations, CAPAs, document review, etc. The QC Manager will also be responsible for the management of external laboratories to include development of Quality Agreements, review of test results and resolution of any issues. Develop and maintain training program within Quality Control which includes, onboarding and continuous training Manage deviations, CAPAs, change controls and document review to ensure compliance Ensure OOS investigations are completed adequately. Manage external laboratories to include development of Quality Agreements, monitoring of samples and test results, reviewing deviations/OOS investigations, resolving issues and developing a scorecard to monitor the quality performance of the external laboratories Identify resources needed for training and compliance and build team accordingly Ensure compliance with applicable cGMP regulations while ensuring compliance with company and client requirements. Monitor effectiveness of CAPAs, change control activities, and audit observation closure. Directly supervises 1-4 employees within the Quality Control department(s).Directly supervised the following roles - Technical Trainers, Compliance Investigators Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions. REQUIREMENTS BA/BS/MS in a science or relevant field required Prior cGMP experience required Prior QC laboratory experience in a cGMP environment a must 3-5 years' experience in the pharmaceutical, biologics ore related industry Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff with a minimum of five (5) years in a management position Sound understanding of cGMPs Experience in laboratory training and compliance External laboratory management experience Strong knowledge of testing methodologies, philosophies, method validation and method transfers. Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner Experience with laboratory training programs Knowledge of GMP requirements Excellent organizational and leadership skills Outstanding analytical problem-solving abilities While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
    $70k-103k yearly est. 31d ago
  • International QC Manager

    Haddad Brands 4.0company rating

    Quality manager job in Dayton, NJ

    Haddad is a privately held family business with 100 years' experience in the children's apparel & accessories industry. A leader in the children's wear industry, Haddad Brands is the exclusive global licensee for the most iconic brands in the world, which include Nike, Jordan, Converse, Hurley, Levi's, Polo, Abercrombie and Fitch, Lacoste, Tommy Hilfiger, Calvin Klein and Huggies. Supported by a team of professionals skilled in design, sourcing, production, sales, marketing & distribution of premium quality children's wear, Haddad distributes globally to 100+ countries and maintains sales and sourcing offices in 22 cities globally, including New York, Paris, Hilversum, Shanghai, Egypt, Bangkok, Vietnam, Sri Lanka, London and Montreal. Overview: The International Quality Manager supports global Quality Control operations by providing leadership, oversight, and coordination of product quality execution across all international regions. This role provides assistance with ensuring consistency of standards, alignment with customer requirements, and effective implementation of global QC initiatives. The manager works closely with director of quality control to strengthen overall product quality. Domestic and international travel is required. Key Accountabilities: Support global QC team initiatives by implementing company quality standards across all international regions Provide guidance to regional QC teams to ensure consistent inspector performance, inspection accuracy, and procedural compliance Partner with overseas managing offices and factory management to resolve quality issues, support corrective actions, and improve factory outgoing product quality Review and analyze global and domestic inspection reports, defect trends, and quality metrics to identify areas for improvement Visit factories as required to review production, evaluate quality risks, and verify corrective actions Communicate critical quality findings and risk assessments to the Director of Quality Control and other cross-functional leaders Support retailer chargeback prevention through compliance oversight and documentation accuracy Partner with the Director of Quality control to develop and refine global QC processes, manuals, and training materials Provide pre-production and inline quality support to factories to reduce final inspection failures Maintain consistent quality communication channels between domestic and international teams Recruit top talent, train and develop team members Special projects as assigned Requirements Required Skills/Abilities/Education: Bachelor's degree in Quality Management, Manufacturing, Engineering, or related field preferred 5-7 years of experience in Quality Control or Quality Assurance within apparel, or consumer products Strong knowledge of global manufacturing processes, inspection methods, and quality assurance systems Prior experience working with overseas factories and international QC teams Excellent communication, coaching, and cross-cultural collaboration skills Strong analytical and problem-solving abilities with attention to detail Ability to work independently across multiple regions and time zones Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook) Ability to travel domestically and internationally as required Consistent in-office presence is vital to the role as it is for all Haddad Brands team members, so that we all have a full appreciation, aesthetically and tactilely, of the qualities that define our brand partners' products and set them apart from their competitors. Salary Description $80,000 - $100,000 per year
    $80k-100k yearly 10d ago
  • Manager, Clinical Research Quality Control

    Clinilabs 4.2company rating

    Quality manager job in Eatontown, NJ

    The Clinical Research Quality Control Manager is a senior leader responsible for the strategic oversight, planning, and execution of all quality control activities within the clinical research unit. This role ensures that clinical trial processes, documentation, and regulatory submissions consistently meet internal standards and external regulatory requirements. The manager leads QC reviews, identifies non-conformances, drives process improvements, and mentors QC staff. RESPONSIBILITIES Strategic Leadership & Oversight Develop, implement, and maintain a comprehensive quality control program for clinical research activities. Lead and mentor QC staff, providing guidance, training, and performance management. Serve as the subject matter expert for QC processes, regulations, and best practices. Quality Control Operations Oversee QC review of clinical documents (source documentation, regulatory binder, pharmacy binder, laboratory binder, presentation materials, and clinical sections of regulatory submissions). Ensure all clinical processes comply with applicable regulations, SOPs, laboratory manuals, and study protocols. Oversee alignment of processing forms and shipping manifests with SOPs and protocols. Attend key study visits to ensure quality and compliance. Follow up on outstanding source documentation review issues with designated staff. Maintain and utilize QC tracking logs for live QC activities. Continuous Improvement & Risk Mitigation Identify non-conformances during clinical trial conduct and lead root cause analyses. Develop and implement risk mitigation strategies and corrective action plans. Drive ongoing process improvement initiatives. Training & SOP Development Lead the writing and review of clinical quality-related SOPs. Regulatory & Compliance Ensure correct IRB-approved informed consent forms and subject source documents are used. Communicate with operational departments regarding project status and issues. Ensure compliance with current Good Clinical Practices (cGCPs) and corporate policies. Strategic Planning & Vision Develop and execute the long-term vision and strategy for quality control across all clinical research programs. Align QC objectives with organizational goals and regulatory trends. Organizational Leadership Lead and manage multiple QC teams or units across sites, ensuring consistency and excellence in QC practices. Oversee recruitment, development, and retention of QC staff; set performance standards and conduct evaluations. Cross-Functional Collaboration Serve as the primary QC liaison to executive leadership, regulatory affairs, clinical operations, and external partners. Lead cross-functional committees focused on quality, compliance, and process improvement. Other Duties Perform other QC-related duties as assigned. TRAVELING Between Corporate New Jersey and New York locations, as needed. Salary Range: $85,000-$95,000 annually. Final compensation is based on skills, experience, location, and overall expertise. Requirements Education: Bachelor's degree in a relevant field (e.g., Life Sciences, Chemistry, Biology, Nursing, or related discipline) required; advanced degree preferred. Experience: Minimum 5 years of progressive experience in clinical research quality control or related field, with at least 2 years in a leadership or management role. Deep knowledge of clinical research processes, regulatory requirements, and QC methodologies. Proven leadership and team management abilities. Excellent communication, analytical, and problem-solving skills. Strong organizational and project management skills. Ability to provide accurate documentation and drive process improvements.
    $85k-95k yearly 22d ago
  • Food Safety Quality Assurance Manager

    Schweid 4.0company rating

    Quality manager job in Carlstadt, NJ

    & Sons Schweid & Sons is a family-owned and operated premium ground beef company with a proud heritage spanning four generations. We supply top-quality beef to Retail, Foodservice, and National Account customers across the U.S. and are committed to quality, customer service, and innovation in protein manufacturing. Summary: This is a leadership role within the organization that is responsible for a broad range of processes, products, and team members over 2 shifts of production as well as the relationship with FSIS and 3rd party sanitation. Essential Job Functions: Food Safety / Regulatory * Managing implementation of the HACCP Plan, its associated documents and including reassessments * Maintaining records in accordance to the policy / HACCP program * Conduct plant GMP inspections and monitor GMP's for compliance * Responsible for maintaining the company's compliance with FSIS regulations. * Ensure compliance with established policies and procedures such as HACCP, GMP's, SSOP, CAPA, and hold and release of products. * Oversee training program for GMP's, HACCP and Food Defense/Food Fraud. * Respond to non-compliance reports issued by FSIS. * Manage the 3rd party Sanitation program for the facility. Quality / Customer Service * Lead 3rd party audits (SQF / Customer Specific) and Customer tours including CAPA's. * Strive for continuous improvements of products, process, procedures, and reliability. * Maintain data of customer requirements, quality specifications and reporting requirements. * Manage quality training program. * Ensure specification compliance for raw materials and finished products. * Managing implementation of quality programs. * Assist with product development and special projects associated with product development. * Respond to customer complaints with CAPA's / letters as needed. * Establish the raw material and finished product shelf life. Other * Contributing to a Safety Culture Manage FSQA Department (Techs, Sanitations, Supervisors) including exempt and non-exempt labor * Manage the department to meet budget. * Other tasks and projects may be assigned. * 10 - 20% travel required Minimum Requirements: * Red Meat Experience a Must * Bachelor of Science in Food Technology, Food Process Engineering, or related field; MS preferred. * 5 plus years' experience working in the Food Industry in a leadership role. * HACCP Knowledge and Experience * SQF / BRC Knowledge and Experience * Ability to think independently and take responsibility for decisions. What We Offer * The expected compensation for this role is $100,000 - $130,000 per year, depending on experience and qualifications. Final compensation will be discussed during the interview process. * Time Off: PTO, Safe & Sick Time, and Paid Holidays. * Health Benefits: Medical, vision, dental, HRA and voluntary disability benefits. * Financial Benefits: 401(k) + employer match and life insurance. * Location: This is an on-site role located in Carlstadt, NJ. * Environment: Our facility is refrigerated. In this role you will be exposed to < 40 degrees for multiple hours of the day.
    $100k-130k yearly 28d ago
  • Supplier Quality Manager

    Lancesoft 4.5company rating

    Quality manager job in Raritan, NJ

    OVERALL RESPONSIBILITIES: Customer Quality member responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. These activities include intake, investigation, documentation, follow-up, regulatory reporting and metrics. The Customer Quality Specialist is responsible for the oversight and direct support of technical evaluations and investigational tasks required for complaint processing/closure. The Customer Quality Specialist works collaboratively with Quality, Engineering, Manufacturing, Product Development and other functional experts. DUTIES: • Responsible and accountable for on-time submission and accuracy of regulatory reports • Review and complete determination associated Medical Device Report and/or Vigilance Report • Knowledge of and familiarity with global regulations for reporting • Directly interface with service centers, Hospitals, Surgeons, and Internal employees for reporting of complaints and adverse events • Interact positively with internal, external business partners and colleagues • Adhere and comply to work instructions, standard operating procedures, and regulations • Expedite investigations by collaborating with internal/external business partners • Achieve productivity targets • Fully trained within three months of hire • Achieve accuracy targets for complaint documentations • Participate in projects and events • Complaint determination • Reportability assessments • Conduct follow-ups with complainant, reporters • Checking your own work • Updating SharePoint • Tracking complaints in the process for closure • All other duties as assigned Qualifications • Bachelor's Degree or equivalent experience • Generally requires 2-4 years of related work experience • RAC or ASQ certifications a plus Additional Information All your information will be kept confidential according to EEO guidelines.
    $88k-111k yearly est. 60d+ ago

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