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  • Director, Supply Chain Food Safety & Quality

    Confidential Jobs 4.2company rating

    Quality manager job in Philadelphia, PA

    Reports To: VP, Corporate Responsibility, Safety & Quality Department: Food Safety & Quality The Director of Supply Chain Food Safety & Quality provides strategic leadership and oversight across an extended supply network that includes co-manufacturers, ingredient and packaging suppliers, shelf-stable product partners, and agricultural operations (fields and coolers). This role ensures that all external partners meet rigorous standards for food safety, regulatory compliance, and product quality-protecting consumers, enabling commercial growth, and strengthening customer trust. This role collaborates closely with Procurement, Supply Chain, Product Development, and Agriculture teams to embed food safety expectations throughout the value chain-from field to finished goods and from concept to commercialization. The Director also works in alignment with internal food safety leaders to maintain one unified enterprise food safety and quality system across both internal facilities and external supply partners. This position is both strategic and forward-looking, building resilient processes across a complex supplier network, anticipating emerging risks, and guiding the organization's capabilities in newer product categories such as shelf-stable and other consumer packaged goods. The Director also plays a key role in supporting the organization's food safety culture and crisis management processes. Primary Responsibilities Lead the development and execution of food safety and quality programs for suppliers, co-manufacturers, shelf-stable product lines, and agricultural operations. Oversee supplier approval, qualification, auditing, and corrective action programs using risk-based frameworks. Partner with Procurement and Supply Chain teams to embed compliance expectations into sourcing decisions, contracts, and supplier performance programs. Collaborate with internal Food Safety & Quality leaders to align standards, share insights, and jointly manage risk across internal and external networks. Provide oversight for agricultural and cooler food safety programs, including GAP compliance, field monitoring, and raw product quality predictability. Manage co-manufacturer onboarding, audit schedules, commercialization readiness, FSMA/GFSI compliance, and incident response related to external manufacturing. Establish KPIs, scorecards, and dashboards to drive visibility, accountability, and continuous improvement across the supply base. Represent the organization externally with regulatory bodies, customers, and industry groups; contribute as a thought leader on supplier, RTE, and shelf-stable food safety topics. Implement advancements in digital tools, predictive analytics, risk modeling, and supplier accountability systems. Lead and develop a team of supplier approval specialists, auditors, and field food safety professionals, fostering a culture of prevention, ownership, and continuous learning. Drive innovation in monitoring, traceability, and system design to proactively identify and mitigate upstream risks. Serve as a member of the Crisis Management team, offering expertise on supply chain and supplier-related food safety incidents. Qualifications 10+ years of progressive leadership in food safety or quality, with experience in CPG, co-manufacturing, RTE/leafy greens, or shelf-stable categories. Bachelor's degree in Food Science, Microbiology, or related field; advanced degree preferred. Strong knowledge of GAP, LGMA, FSMA, HACCP, GMPs, GFSI standards, and supplier food safety programs. Proven experience managing co-manufacturers, suppliers, and agricultural food safety programs. Ability to influence senior leaders internally and externally, including customers and regulatory agencies. Strong collaboration skills with a track record of aligning cross-functional teams under a unified strategy. Experience deploying digital tools, data systems, and continuous improvement methodologies to enhance food safety capability. Essential Job Functions Ability to climb stairs Ability to lift up to 25 lbs Ability to sit at a workstation for extended periods
    $95k-121k yearly est. 4d ago
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  • Manager Quality Systems & Compliance

    Piramal Pharma Solutions

    Quality manager job in Sellersville, PA

    Piramal Pharma Solutions is seeking an experienced Manager, Quality Systems & Compliance to lead and maintain robust quality systems and ensure compliance with global regulatory requirements at our Sellersville site. This role is critical in supporting cGMP and regulatory compliance across manufacturing, testing, warehousing, and distribution operations for pharmaceutical drug products. The successful candidate will ensure quality systems are effectively implemented, aligned with company quality policies, and continuously improved to meet evolving regulatory and business needs. Key Responsibilities Quality Systems Leadership Serve as system administrator for electronic Quality Management Systems (eQMS), including ComplianceWire, TrackWise, Ensur, eBMR, and eForms. Ensure effective use of quality systems to support site compliance and continuous improvement initiatives. Review and approve quality system records, including deviations, CAPAs, change controls, and training records. Training Program Management Oversee all site training activities and ensure compliance with regulatory and internal requirements. Partner with department heads and SMEs to develop, implement, and maintain training curricula. Provide guidance and training to end users on quality systems and processes. Document Control Manage the site SOP program and overall document control lifecycle. Oversee document management activities, including Master Batch Records and protocols. Compliance & Governance Lead Quality System Committees (QSCs) and review boards, including Deviation, CAPA, and Change Control Review Boards. Provide quality system metrics on a weekly, monthly, and quarterly basis. Manage Annual Product Reviews (APRs). Oversee complaint, FAR, and recall management processes. Manage Quality Technical Agreements (QTAs). Audit & Supplier Management Lead the Supplier Management Program. Manage internal, external, client, and regulatory audits. Actively support regulatory inspections and client audits. Data Integrity & Computer Systems Serve as Site Data Integrity Compliance Officer (DICO). Manage the site Data Integrity Program. Oversee the Computer System Validation (CSV) program. Support implementation and upgrades of electronic systems. Continuous Improvement Collaborate with the corporate quality team to implement global policies and procedures. Support site quality improvement initiatives and special projects. Ensure adherence to site safety standards. Perform additional Quality Systems & Compliance activities as assigned. Required Qualifications Education Bachelor's degree or higher in a scientific, quality assurance, or technical discipline. Experience Minimum of 10+ years in a manufacturing environment with QA, Quality Systems, and/or Compliance experience in a cGMP/FDA-regulated industry. At least 5 years in a supervisory or managerial role. Technical & Functional Skills In-depth knowledge of global pharmaceutical regulations (FDA, EMA, PDMA, ANVISA, TGA, DEA). Strong understanding of Quality Management Systems for non-sterile pharmaceutical manufacturing. Hands-on experience with eQMS platforms (DMS, LMS, eBMR). Proven experience in audits, supplier management, and data integrity. Excellent organizational, communication, and cross-functional collaboration skills. Proficient in Microsoft Office and standard business systems. Ability to manage multiple projects and priorities simultaneously.
    $88k-132k yearly est. 1d ago
  • Senior Editorial and Quality Lead (Healthcare Agency)

    Breaking Data 3.9company rating

    Quality manager job in Cherry Hill, NJ

    Breaking Data is a boutique healthcare marketing agency serving leading pharmaceutical, biotech, and medical device companies. We specialize in scientific storytelling, creative strategy, and high-impact communications that bring complex brand narratives to life across print, digital, and training platforms. Founded by marketers, for marketers, we pride ourselves on delivering thoughtful, intuitive, and beautifully executed work. Our team is full of “A-teamers”: curious, collaborative, detail-driven people who care deeply about the craft and the quality of what we create. We believe co-location fuels creativity, alignment, and culture. While we offer flexibility, this role is intended for someone who can work 3 days onsite in our Cherry Hill, NJ office and 2 days remote. Senior Editorial and Quality Lead (Healthcare Agency)| Boutique Life Sciences Agency Location: US-Cherry Hill, NJ Employment Type: Full-time Benefits: Health Insurance Compensation, 401K program, Paid time off, and company holidays Opportunity Overview Breaking Data seeks a meticulous Senior Editorial and Quality Lead to serve as the central hub for editorial excellence across pharmaceutical and healthcare deliverables. This hands-on role owns quality control from post-writing drafts through design, reviews, and client approvals-focusing on grammar, style mastery, layout accuracy, and workflow efficiency. Ideal for an experienced editor passionate about the craft of editing. About the Role The Senior Editorial and Quality Lead will own editorial quality control as the central hub across all deliverables-from post-medical writing drafts through design layouts, internal strategy reviews, and client approvals. This hands-on role encompasses proofreading, light editing, layout verification, and workflow coordination for slides, print materials, digital assets, training modules, and long-form content, serving pharmaceutical and healthcare clients. Work closely with medical writers, designers, strategists, and account teams to ensure grammar, style, accuracy, and layout integrity meet the highest agency and client standards. Key Responsibilities Editorial Quality Control Proofread and edit copy developed by medical writers for grammar, clarity, consistency, spelling, accuracy, AMA Manual of Style, and client-specific guidelines. Verify references, superscripts, citations, medical terminology, numeric values, units, symbols, and data formatting. Perform light editing or rewrites to address minor issues and maintain project efficiency. Brand & Compliance Consistency Ensure content aligns with each client's editorial style, tone, branding expectations, and regulatory requirements (including PI/ISI placement when applicable). Confirm correct application of references, anchors, superscripts, and citation formatting. Design & Layout Review Review designed documents and slides (PowerPoint, InDesign, PDFs) to confirm clean, consistent formatting and layout. Verify alignment between copy and design elements (tables, charts, visuals, callouts); identify inconsistencies in spacing, bullets, alignment, superscripts, or content order that could alter meaning. Process & Workflow Execution Manage editorial checkpoints and coordinate handoffs across medical writers, designers, internal strategy reviewers, and clients on multiple concurrent projects. Implement QC edits directly; track and ensure all internal, client, and MLR feedback is accurately incorporated with proper version control and file naming. Serve as the final quality assurance step before client delivery. Requirements Minimum 4-5 years of editorial or proofreading experience in a healthcare, pharmaceutical, or medical communications agency setting. Strong knowledge of the AMA Manual of Style and the ability to apply client-specific style guides and branding requirements. Experience reviewing healthcare or scientific content with a high level of accuracy for terminology, data, units, and references. Demonstrated ability to manage multiple projects and deadlines in a fast-paced, detail-oriented environment. Proficiency in Microsoft Office, Adobe Acrobat Pro, and cloud-based document systems (eg, SharePoint/OneDrive). Exceptional attention to detail and a commitment to editorial precision and quality control. Strong communication and collaboration skills for working with medical writers, designers, strategists, and account teams. Education Bachelor's degree in English, Communications, Journalism, or a related field; a life sciences background is a plus but not required for this role. Work environment Our Cherry Hill, NJ office offers a flexible and collaborative environment. We align projects with each team member's core skills, striking a balance between fun and efficiency to achieve our goals and those of our clients. This is a hybrid position, with 3 days onsite and 2 days remote. Application Process To apply, please submit your resume (and, if available, editing samples) directly through this LinkedIn job posting. Candidates selected for the next steps will be asked to complete a brief editing exercise.
    $78k-110k yearly est. 3d ago
  • Quality Assurance & Control Manager (Electric Utility Construction)

    IB Abel Inc. 3.5company rating

    Quality manager job in Philadelphia, PA

    If you need assistance with the application process, please notify IB Abel's Human Resources Department. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. About Us IB Abel's 110-year history is a testament to its adaptability, forward-thinking leadership, commitment to safety, and stellar service and project delivery process. Our core values-Responsible, Integrity, Results-Oriented, Ownership, and Professional-shape everything that we do at all levels of the company and are purposefully incorporated into all company communications, meetings, and strategic planning. Our use of the EOS model (Entrepreneurial Operating System) also provides structure and clarity among all levels of the company to maintain focus on our shared goals. IB Abel (IBA) is committed to providing ample learning and career development opportunities to its team members via our Associate's Program in Project Management, Estimating, and Accounting and our growing Learning Management System. The Opportunity We are seeking an experienced Quality Assurance Manager who is responsible for establishing, implementing, and maintaining the company's Quality Assurance and Quality Control program across all transmission, distribution, substation, and civil construction projects. This role ensures all work is performed to contract requirements, industry standards, and customer specifications. The QA/QC Manager partners closely with Safety, Operations, Project Management, and Field Leadership to drive consistency, reduce rework, promote right-first-time execution, and support a culture of continuous improvement. Key Responsibilities Quality Program Leadership - Develop, implement, and manage the company-wide QA/QC program tailored for utility construction (T&D, substation, and civil); establish quality standards, inspection processes, checklists, and documentation that align with utility customer requirements; and maintain quality manuals, procedures, and work instructions in alignment with industry best practices. Project Support & Field Oversight - Conduct field QA/QC audits, inspections, and work observations to verify compliance with engineered drawings, specifications, construction standards, and work methods; ensure crews understand and apply proper installation practices for poles, structures, conductors, and all related civil work; support project teams in interpreting drawings, standards, and technical requirements; and review and approve ITPs (Inspection & Test Plans), hold points, material submittals, and commissioning documentation. Documentation & Reporting - Maintain accurate QA/QC records, including inspection reports, NCRs (Non-Conformance Reports), corrective actions, testing results, photos, and QA/QC logs; prepare quality reports for leadership and customers, identifying trends, recurring deficiencies, and recommended improvements; and oversee turnover documentation and quality packages for customers. Non-Conformance & Corrective Action - Lead investigations into quality-related issues, rework events, or specification deviations; develop corrective and preventive action plans with field leadership and project teams; and track closure of NCRs to ensure accountability and lessons learned. Training & Continuous Improvement - Deliver training for foremen, line workers, operators, and civil crews on quality standards and proper installation techniques; support onboarding of new field leaders by reinforcing customer-specific construction standards; collaborate with Safety, Operations, and L&D to develop technical guidance, SOPs, and best practices; and lead quality-focused continuous improvement initiatives to reduce defects and rework. Customer & Regulatory Interface - Serve as the QA/QC point of contact for utility clients, inspectors, and third-party engineering firms; coordinate with customer QA reps, attend pre-construction meetings, and support project QC reviews; and ensure compliance with all customer requirements, environmental guidelines, and applicable regulatory standards. Who We're Looking For An acceptable combination of education and/or work experience including 7+ years of experience in electric utility construction (transmission, distribution, or substation) as well as 3+ years in a QA/QC, construction management, or field leadership role. Experience with civil construction related to utility infrastructure (foundations, excavation, concrete, site work). Familiarity with utility standards (e.g., IEEE, NESC, ASTM, utility-specific specifications). Proficient in quality documentation systems such as SiteDocs, Aclaimant, Procore, or similar. Local to Pennsylvania but with regular travel to other offices, customer facilities, jobsites and yard locations for offsite meetings (flexibility to work from home when appropriate). A “can-do” attitude, strong work ethic, excellent attention to detail, and ability to collaborate effectively with various teams. Why Choose IBA Culture of Growth: Many of our leaders started in entry-level field roles and advanced within the company. Flexibility & Autonomy: We empower our team to succeed without micromanagement. Competitive Compensation & Benefits: Includes competitive salary, vehicle allowance program, 401(k) with company matching, tuition reimbursement, and comprehensive benefits package including medical, dental, and vision. Stability & Variety: Work for multi-generational family-oriented business on diverse, fast-paced projects without the stress of a large corporate structure. Incentives: Performance-based bonuses/incentives and a progressive PTO programs that grows with your tenure! Collaboration: A team environment where we work together to solve challenges and celebrate wins. Step Into a Career That Powers the Future! IB Abel is an equal opportunity employer, all qualified applicants are encouraged to apply.
    $80k-108k yearly est. 44d ago
  • Director of Sterility Assurance

    8427-Janssen Cilag Manufacturing Legal Entity

    Quality manager job in Raritan, NJ

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Quality Job Sub Function: Quality Assurance Job Category: People Leader All Job Posting Locations: Raritan, New Jersey, United States of America Job Description: Johnson & Johnson is currently recruiting for Director of Sterility Assurance! This position will be located in Raritan, NJ. Position Summary: The Director of Sterility Assurance is a leadership role responsible for overseeing all microbiological and virological control aspects of cell and gene therapy product manufacturing at the Raritan facility. This role ensures the safety, quality, and compliance of our products and processes through the development, implementation, and management of robust testing programs, risk assessments, and quality systems. The Director will provide technical expertise and strategic direction in microbiology and virology. The candidate will consult with JNJ manufacturing facilities, Global and Site Quality and Global Sterility Assurance and other functions to educate on the Sterility Assurance program requirements and proactively ensure compliance of the JNJ Sterility Assurance program with various country agency standards, industry trends and scientific principles. Key Responsibilities: Raritan Site Quality Management Responsibilities (80%) Develop, and maintain oversight of comprehensive microbiology and virology programs, including environmental monitoring, incoming material testing, in-process testing, lot release testing, and stability testing. Serves as primary point of contact and decision maker for internal policies, procedures, and strategy documents governing Sterility Assurance and Contamination Control related topics. Support in knowledge advancement beyond the Quality organization to build, maintain, and develop capabilities across the JNJ network for the Sterility Assurance space. Development of knowledge-based programs to advance company education and training programs. Provide mentoring leadership to stakeholder SMEs to build capability for new and existing sites or where gaps in technical expertise have been identified. Sponsor and oversee activities focused on driving process improvements and harmonization projects across the JNJ network for Sterility Assurance and Contamination Control. Serve as the SME leadership role for topics associated with Sterility Assurance and Contamination Control across the network, representing on network teams and other appropriate governance forums. Provide technical support to during new process design and facility change activities to ensure Sterility Assurance programs and product requirements are supported at the sites. Engage in providing support during regulatory submissions and on-site inspections. Define and execute the process for managing observations and commitments related to Sterility Assurance for the Raritan. Accountable for transformation of sterility assurance global standards across Engineering, MSAT and Quality and ensuring that they are in use across all sites. Set vision for the future to proactively meet regulatory expectations. Accountable for program management for execution / implementation to global standards Deliver Annex 1 compliance through standardized global policies. Implement KPI dashboards for contamination control. Define clear project and governance frameworks to clarify roles and responsibilities between global and local teams. Drive continuous improvement and proactive inspection readiness with storyboard creation and coaching/mentoring. Lead the uplift in capability building and leadership development across functions. External network/advocacy with industry forums and regulators to keep pace with evolving regulatory expectations and emerging technology. Leadership Team Responsibilities (20%) Sets and manages targets and objectives for the Raritan site ensuring alignment with overall company strategy. Drives the achievement of annual goals, guided by Our Credo and leadership principles. Builds and sustains strong relationships with internal and external stakeholders, including Global Quality teams, Manufacturing, Quality Control, Facilities and Engineering, and partners. Coordinates quality-related activities across departments, sites, and organizations to proactively support and optimize business processes. Ensure the Sterility Assurance department has a clear organizational structure, with robust formation and succession plans to support long-term stability. Provides leadership to build a high-performing, collaborative team through hiring, mentoring, and talent development. Champions a culture of quality compliance, diversity, inclusion, and continuous improvement. Manages professionals within the Quality team, fostering ongoing talent development and succession planning. Collaborates with the VP, IMSC Quality, and other site Quality Heads as part of the Advanced Therapies Quality Leadership Team (ATQLT) to ensure harmonization and standardization across sites. Partners with cross-functional leaders to support continuous improvement and lifecycle management of GMP policies and the QMS. Represents Raritan in the planning, development, and execution of corporate Quality initiatives. Establishes effective partnerships across business units, sites, and functions to ensure integrated and efficient business processes. Qualifications: Education: A minimum of a Bachelors or equivalent University degree is required with a focus in pharmacy, engineering, chemistry, microbiology or related scientific / engineering discipline preferred. Masters or advanced degree preferred. Required: Minimum of 10 years of Quality Assurance / Quality Systems experience related to manufacturing Comprehensive knowledge of vaccines, biological manufacturing and related Quality management processes and systems Proven people management and Quality leadership experience Strong people leadership skills and a proven track record in attracting, developing and retaining talent in the organization Comprehensive regulatory cGMP and technical knowledge to develop sterility assurance strategies necessary to maintain the desired level of inspection readiness Experience hosting global regulatory agency inspections and successfully presenting product and quality compliance programs to regulatory reviewers Experience with implementing and overseeing cGMP operations in a commercial manufacturing facility Demonstrated experience building and leading exceptional Quality Assurance, Quality Systems and Quality Control teams Extensive knowledge of chemical, biochemical and microbiological concepts Knowledge of cGMP regulations and FDA/EU guidance Fluent in English (written and spoken) Preferred: Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is highly preferred Strategic thinking with the ability to manage/master complexity and to act as a sponsor for change Ability to prioritize and guide the organization in coping with the demands of a rapidly changing environment Ability to apply appropriate risk assessment strategies to manage business & compliance priorities Effective negotiation and influencing skills and lead with a mindset of continuous improvement Balanced decision-making skills and ability to effectively resolve conflict, when needed Business acumen; develop and control budgets Ability to communicate effectively with different levels in the organization and with health authorities Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource Required Skills: Preferred Skills: Aseptic Processing, Clean Room Manufacturing, Contamination Control, Risk Assessments The anticipated base pay range for this position is : $150,000.00 - $258,750.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year For additional general information on Company benefits, please go to: - *********************************************
    $150k-258.8k yearly Auto-Apply 9d ago
  • Director of Sterility Assurance

    6120-Janssen Scientific Affairs Legal Entity

    Quality manager job in Raritan, NJ

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Quality Job Sub Function: Quality Assurance Job Category: People Leader All Job Posting Locations: Raritan, New Jersey, United States of America Job Description: Johnson & Johnson is currently recruiting for Director of Sterility Assurance! This position will be located in Raritan, NJ. Position Summary: The Director of Sterility Assurance is a leadership role responsible for overseeing all microbiological and virological control aspects of cell and gene therapy product manufacturing at the Raritan facility. This role ensures the safety, quality, and compliance of our products and processes through the development, implementation, and management of robust testing programs, risk assessments, and quality systems. The Director will provide technical expertise and strategic direction in microbiology and virology. The candidate will consult with JNJ manufacturing facilities, Global and Site Quality and Global Sterility Assurance and other functions to educate on the Sterility Assurance program requirements and proactively ensure compliance of the JNJ Sterility Assurance program with various country agency standards, industry trends and scientific principles. Key Responsibilities: Raritan Site Quality Management Responsibilities (80%) Develop, and maintain oversight of comprehensive microbiology and virology programs, including environmental monitoring, incoming material testing, in-process testing, lot release testing, and stability testing. Serves as primary point of contact and decision maker for internal policies, procedures, and strategy documents governing Sterility Assurance and Contamination Control related topics. Support in knowledge advancement beyond the Quality organization to build, maintain, and develop capabilities across the JNJ network for the Sterility Assurance space. Development of knowledge-based programs to advance company education and training programs. Provide mentoring leadership to stakeholder SMEs to build capability for new and existing sites or where gaps in technical expertise have been identified. Sponsor and oversee activities focused on driving process improvements and harmonization projects across the JNJ network for Sterility Assurance and Contamination Control. Serve as the SME leadership role for topics associated with Sterility Assurance and Contamination Control across the network, representing on network teams and other appropriate governance forums. Provide technical support to during new process design and facility change activities to ensure Sterility Assurance programs and product requirements are supported at the sites. Engage in providing support during regulatory submissions and on-site inspections. Define and execute the process for managing observations and commitments related to Sterility Assurance for the Raritan. Accountable for transformation of sterility assurance global standards across Engineering, MSAT and Quality and ensuring that they are in use across all sites. Set vision for the future to proactively meet regulatory expectations. Accountable for program management for execution / implementation to global standards Deliver Annex 1 compliance through standardized global policies. Implement KPI dashboards for contamination control. Define clear project and governance frameworks to clarify roles and responsibilities between global and local teams. Drive continuous improvement and proactive inspection readiness with storyboard creation and coaching/mentoring. Lead the uplift in capability building and leadership development across functions. External network/advocacy with industry forums and regulators to keep pace with evolving regulatory expectations and emerging technology. Leadership Team Responsibilities (20%) Sets and manages targets and objectives for the Raritan site ensuring alignment with overall company strategy. Drives the achievement of annual goals, guided by Our Credo and leadership principles. Builds and sustains strong relationships with internal and external stakeholders, including Global Quality teams, Manufacturing, Quality Control, Facilities and Engineering, and partners. Coordinates quality-related activities across departments, sites, and organizations to proactively support and optimize business processes. Ensure the Sterility Assurance department has a clear organizational structure, with robust formation and succession plans to support long-term stability. Provides leadership to build a high-performing, collaborative team through hiring, mentoring, and talent development. Champions a culture of quality compliance, diversity, inclusion, and continuous improvement. Manages professionals within the Quality team, fostering ongoing talent development and succession planning. Collaborates with the VP, IMSC Quality, and other site Quality Heads as part of the Advanced Therapies Quality Leadership Team (ATQLT) to ensure harmonization and standardization across sites. Partners with cross-functional leaders to support continuous improvement and lifecycle management of GMP policies and the QMS. Represents Raritan in the planning, development, and execution of corporate Quality initiatives. Establishes effective partnerships across business units, sites, and functions to ensure integrated and efficient business processes. Qualifications: Education: A minimum of a Bachelors or equivalent University degree is required with a focus in pharmacy, engineering, chemistry, microbiology or related scientific / engineering discipline preferred. Masters or advanced degree preferred. Required: Minimum of 10 years of Quality Assurance / Quality Systems experience related to manufacturing Comprehensive knowledge of vaccines, biological manufacturing and related Quality management processes and systems Proven people management and Quality leadership experience Strong people leadership skills and a proven track record in attracting, developing and retaining talent in the organization Comprehensive regulatory cGMP and technical knowledge to develop sterility assurance strategies necessary to maintain the desired level of inspection readiness Experience hosting global regulatory agency inspections and successfully presenting product and quality compliance programs to regulatory reviewers Experience with implementing and overseeing cGMP operations in a commercial manufacturing facility Demonstrated experience building and leading exceptional Quality Assurance, Quality Systems and Quality Control teams Extensive knowledge of chemical, biochemical and microbiological concepts Knowledge of cGMP regulations and FDA/EU guidance Fluent in English (written and spoken) Preferred: Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is highly preferred Strategic thinking with the ability to manage/master complexity and to act as a sponsor for change Ability to prioritize and guide the organization in coping with the demands of a rapidly changing environment Ability to apply appropriate risk assessment strategies to manage business & compliance priorities Effective negotiation and influencing skills and lead with a mindset of continuous improvement Balanced decision-making skills and ability to effectively resolve conflict, when needed Business acumen; develop and control budgets Ability to communicate effectively with different levels in the organization and with health authorities Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource Required Skills: Preferred Skills: Aseptic Processing, Clean Room Manufacturing, Contamination Control, Risk Assessments The anticipated base pay range for this position is : $150,000.00 - $258,750.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year For additional general information on Company benefits, please go to: - *********************************************
    $150k-258.8k yearly Auto-Apply 9d ago
  • Food Safety Quality Assurance Manager Protein (2nd Shift)

    The Clemens Food Group 4.5company rating

    Quality manager job in Hatfield, PA

    Step into a pivotal leadership role at Clemens Food Group, where your impact on food safety, people leadership, and product quality will be seen daily. Internally, this role is called a Superintendent, but externally we're seeking an Assistant FSQA Manager-a role often known in other organizations as a Food Safety Manager, Quality Assurance Manager, or FSQA Manager. In this role, you'll lead a team of QA supervisors and technicians in a USDA-regulated meat processing facility, ensuring compliance with HACCP, SSOPs, GMPs, and audit readiness. As the senior-most FSQA authority on second shift, you'll balance hands-on floor leadership with root cause analysis, corrective actions, and continuous improvement projects in one of our largest protein production plants. Shift Details Shift starts at 3:00 PM and runs for 9 hours As a management-level position, flexibility is expected-shifts may start or end an hour earlier or later based on operational needs On-call approximately one out of every four weekends The Impact You'll Make You'll own the shift. Literally. From running handoffs and leading root cause investigations to coaching your team and making critical decisions during audits or equipment failures-this role gives you end-to-end visibility and influence. Your leadership will drive our KPIs around safety, first pass quality, and regulatory compliance. What You'll Do Lead and develop a second-shift FSQA team (multiple supervisors and techs) Be the point of contact for USDA, customer complaints, and urgent investigations Review and act on trend data to improve quality and reduce CPMs Collaborate cross-functionally with Ops, R&D, and Sanitation Manage issue resolution, floor presence, audits, and on-call response (1 in 4 weekends) Prioritize food safety and people leadership at every turn What Makes This Role Exciting? You're the top FSQA decision-maker on your shift Gain experience in a high-capacity, 1.3M sq. ft. protein facility Every day brings new projects, challenges, and growth moments Room to grow-this role is a stepping stone to FSQA Manager What We're Looking For Proven FSQA leadership, meat/poultry/seafood industry required Proven ability to lead teams and manage performance Strong background in USDA, HACCP, audits, and corrective actions Comfortable with ambiguity, fast pace, and solving complex floor issues Skills & Mindset High initiative: confident in making decisions without constant direction Project-focused: can organize chaos into action plans and results People-first: builds trust, holds people accountable, and develops others Strong communicator: connects across functions, listens well, and presents data clearly Your Future at Clemens This isn't just a shift job-it's a career-building leadership role. We'll support your onboarding, help you get grounded in our culture, and give you visibility that sets the stage for broader advancement within FSQA. Application Note: Clemens Food Group is not accepting unsolicited resumes from search or staffing firms. All resumes submitted by search or staffing firms to any employee at Clemens Food Group via email, the Internet, or directly without a valid written search agreement for this role, and without having been asked to participate in this by Talent Acquisition, will be deemed the sole property of Clemens Food Group, and no fee will be paid in the event the candidate is hired. Firms not authorized to submit candidates will not be eligible for any fee or ownership claim. #LG-AG1 Keywords Food Safety, Quality Assurance, Food Safety Supervisor, FSQA Manager, Assistant Food Safety Manager, Meat Processing QA, USDA Compliance, HACCP, SQF, Food Manufacturing, Protein Industry, QA Team Leader, Quality Systems, Food Safety and Sanitation, Second Shift Food Safety, Regulatory Compliance, Food Plant QA, FSQA Superintendent, Assistant QA Manager. #LI-AG1
    $69k-100k yearly est. 60d+ ago
  • Director, Clinical Quality Assurance

    Eisai Us 4.8company rating

    Quality manager job in Philadelphia, PA

    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 :195,000-256,000 Under 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
    $92k-129k yearly est. Auto-Apply 60d+ ago
  • SAP Quality Management/Manufacturing Manager - Chemicals Industry

    Accenture 4.7company rating

    Quality manager job in Philadelphia, PA

    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 54d ago
  • Manager, Corporate Food Safety and Quality

    External

    Quality manager job in Philadelphia, PA

    Manager, Corporate Food Safety and Quality Department: Corporate Food Safety & Quality Reports To: Director, Food Safety & Quality Salary Type: Exempt Make a greater impact at Bonduelle Americas! At Bonduelle Americas, we're on a mission to make plant-rich eating easy, accessible, and joyful for everyone. As a certified B Corp, we invite people to embrace a flexitarian lifestyle with an expanding portfolio of plant-rich products available in and beyond the produce aisle. With four facilities and nearly 3,000 Associates in the US, we're part of something bigger: a global movement rooted in over 170 years of family heritage. Our parent company, Groupe Bonduelle (BON.PA), brings plant-rich foods to tables in nearly 100 countries and partners with growers who cultivate more than 173,000 acres of fresh, nutritious produce each year. At Bonduelle-Americas, you'll find more than just a career, you'll find purpose with a team that puts people first, values sustainability, and believes in doing well by doing good. Together, we're inspiring the shift towards a plant-rich diet that nourishes both people and the plant. Position Summary: This job leads the overall food safety and quality programs within the manufacturing pillar of Bonduelle Americas. The Manager, Corporate Food Safety and Quality is responsible for the development, oversight, and execution of the Food Safety and Quality programs at all internal BA manufacturing facilities and internal warehouses/3PLs. This position effectively collaborates with facility operations leadership and cross-functional departments to drive the food safety and quality metrics, compliance and continuous improvement in products and processes to meet internal, customer and regulatory requirements. This role is a key part of BA's success by directing the development, implementation and continuous improvement of food safety and quality assurance systems, standards and programs to ensure the delivery of safe, wholesome, quality products to our customers nationally. The ideal candidate will demonstrate acute critical thinking skills and the ability to craft and execute solutions in a fast-changing environment. This candidate must be forward-thinking in their approach to maintaining the food safety and quality of our products, while modeling and acting in accordance with Bonduelle's mission, vision, and principles. What You'll Do Lead and Develop the Team: Directly supervise a team of Food Safety and Quality professionals, including Specialists, fostering a culture of accountability, collaboration, and continuous improvement. Oversee Food Safety & Quality Systems: Manage all food safety and quality programs across internal manufacturing and warehousing sites - from raw material receipt through finished product delivery. Establish and Maintain Programs: Develop, implement, and verify all produce-related food safety and quality policies, procedures, and records. Oversee programs related to training, change management, and document control (including version control, distribution, archival, retrieval, retention, and destruction). Benchmark and Align Programs: Ensure Bonduelle's food safety and quality standards are aligned with broader corporate initiatives and benchmarked against industry best practices. Audit Readiness & Leadership: Support facilities in maintaining audit readiness (SQF, Commercial Food Sanitation, customer, and regulatory audits) and serve as the Corporate lead during such audits. Ensure Hygienic Design & Sanitation: Oversee hygienic design, traffic flow, sanitation programs, and environmental monitoring across all sites in accordance with CFS and regulatory requirements. Drive Continuous Improvement: Lead initiatives to enhance process controls, performance metrics, and customer complaint resolution through a data-driven approach. Champion Digital Quality Systems: Act as a quality leader for digital food safety and quality applications, leveraging data analytics to track metrics, identify trends, and drive continuous improvement. Customer Support: Partner with Sales and Consumer Relations to address customer and consumer food safety or quality concerns, including communication, questionnaires, and portal management. Technical Expertise: Serve as a subject matter expert on food safety and quality for both internal stakeholders and external partners. Innovation Support: Collaborate with Product Development and cross-functional teams to ensure the safety and quality of new and existing products. Corporate Audit & Compliance: Manage the Corporate internal audit program to verify compliance with company and regulatory standards. Recall & Traceability: Support the execution of product recall and traceability exercises. Sustainability & ESG: Contribute to environmental and social initiatives, advancing progress toward Bonduelle's ESG and B Corp certification goals. Project Leadership: Lead and influence large-scale, cross-functional projects and initiatives to elevate organizational food safety and quality performance. Additional Duties: Perform other related responsibilities as assigned. What you'll bring: Experience & Education: 10+ years of supplier food safety experience within the food industry, or 5+ years with a master's degree in a related field. Minimum of 3 years in a supervisory or leadership capacity. Regulatory Expertise: Strong understanding of food safety regulations (USDA, FDA, etc.) and familiarity with fresh produce standards preferred. Audit Proficiency: Hands-on experience with Global Food Safety Initiative (GFSI) audit schemes-SQF certification preferred; exposure to other audit programs is a plus. Analytical Strength: Skilled in analyzing complex data, identifying root causes, and recommending effective, data-driven solutions. Quality Leadership: Knowledge of quality assurance methodologies within manufacturing environments; able to design, communicate, and champion continuous improvement initiatives. Technical Fluency: Proficient in Microsoft 365 (Excel, Word, PowerPoint) and comfortable with data analytics platforms such as Tableau, Power BI, or JDE. Exceptional Communicator: Excellent written and verbal communication skills; able to partner effectively across all levels and functions. Collaborative & Resilient: Thrives in fast-paced, changing environments; skilled in managing conflict, resolving issues, and leading through ambiguity. Project Management: Proven ability to manage multiple projects end-to-end and drive measurable outcomes. Flexibility: Willingness to travel up to 50%, with occasional night or weekend work as needed to support plant operations and audits. Compensation and Benefits: The base salary for this role typically ranges from $114,000 to $126,000 annually. Actual compensation will be determined based on a combination of factors, including skills, experience, expertise, and location. In addition to base pay, this position may be eligible for bonuses or other incentive programs as part of a comprehensive total rewards package, which includes: Medical, dental, and vision coverage with multiple plan options 401(k) retirement savings plan Generous paid time off and paid holidays Tuition reimbursement and professional development programs Employee discounts, wellness initiatives, and company-sponsored events Life at Bonduelle: Learn more by visiting: ***************************************
    $114k-126k yearly 60d+ ago
  • Manager, Corporate Food Safety and Quality

    Ba Candidate Gateway

    Quality manager job in Philadelphia, PA

    Manager, Corporate Food Safety and Quality Department: Corporate Food Safety & Quality Reports To: Director, Food Safety & Quality Salary Type: Exempt Make a greater impact at Bonduelle Americas! At Bonduelle Americas, we're on a mission to make plant-rich eating easy, accessible, and joyful for everyone. As a certified B Corp, we invite people to embrace a flexitarian lifestyle with an expanding portfolio of plant-rich products available in and beyond the produce aisle. With four facilities and nearly 3,000 Associates in the US, we're part of something bigger: a global movement rooted in over 170 years of family heritage. Our parent company, Groupe Bonduelle (BON.PA), brings plant-rich foods to tables in nearly 100 countries and partners with growers who cultivate more than 173,000 acres of fresh, nutritious produce each year. At Bonduelle-Americas, you'll find more than just a career, you'll find purpose with a team that puts people first, values sustainability, and believes in doing well by doing good. Together, we're inspiring the shift towards a plant-rich diet that nourishes both people and the plant. Position Summary: This job leads the overall food safety and quality programs within the manufacturing pillar of Bonduelle Americas. The Manager, Corporate Food Safety and Quality is responsible for the development, oversight, and execution of the Food Safety and Quality programs at all internal BA manufacturing facilities and internal warehouses/3PLs. This position effectively collaborates with facility operations leadership and cross-functional departments to drive the food safety and quality metrics, compliance and continuous improvement in products and processes to meet internal, customer and regulatory requirements. This role is a key part of BA's success by directing the development, implementation and continuous improvement of food safety and quality assurance systems, standards and programs to ensure the delivery of safe, wholesome, quality products to our customers nationally. The ideal candidate will demonstrate acute critical thinking skills and the ability to craft and execute solutions in a fast-changing environment. This candidate must be forward-thinking in their approach to maintaining the food safety and quality of our products, while modeling and acting in accordance with Bonduelle's mission, vision, and principles. What You'll Do Lead and Develop the Team: Directly supervise a team of Food Safety and Quality professionals, including Specialists, fostering a culture of accountability, collaboration, and continuous improvement. Oversee Food Safety & Quality Systems: Manage all food safety and quality programs across internal manufacturing and warehousing sites - from raw material receipt through finished product delivery. Establish and Maintain Programs: Develop, implement, and verify all produce-related food safety and quality policies, procedures, and records. Oversee programs related to training, change management, and document control (including version control, distribution, archival, retrieval, retention, and destruction). Benchmark and Align Programs: Ensure Bonduelle's food safety and quality standards are aligned with broader corporate initiatives and benchmarked against industry best practices. Audit Readiness & Leadership: Support facilities in maintaining audit readiness (SQF, Commercial Food Sanitation, customer, and regulatory audits) and serve as the Corporate lead during such audits. Ensure Hygienic Design & Sanitation: Oversee hygienic design, traffic flow, sanitation programs, and environmental monitoring across all sites in accordance with CFS and regulatory requirements. Drive Continuous Improvement: Lead initiatives to enhance process controls, performance metrics, and customer complaint resolution through a data-driven approach. Champion Digital Quality Systems: Act as a quality leader for digital food safety and quality applications, leveraging data analytics to track metrics, identify trends, and drive continuous improvement. Customer Support: Partner with Sales and Consumer Relations to address customer and consumer food safety or quality concerns, including communication, questionnaires, and portal management. Technical Expertise: Serve as a subject matter expert on food safety and quality for both internal stakeholders and external partners. Innovation Support: Collaborate with Product Development and cross-functional teams to ensure the safety and quality of new and existing products. Corporate Audit & Compliance: Manage the Corporate internal audit program to verify compliance with company and regulatory standards. Recall & Traceability: Support the execution of product recall and traceability exercises. Sustainability & ESG: Contribute to environmental and social initiatives, advancing progress toward Bonduelle's ESG and B Corp certification goals. Project Leadership: Lead and influence large-scale, cross-functional projects and initiatives to elevate organizational food safety and quality performance. Additional Duties: Perform other related responsibilities as assigned. What you'll bring: Experience & Education: 10+ years of supplier food safety experience within the food industry, or 5+ years with a master's degree in a related field. Minimum of 3 years in a supervisory or leadership capacity. Regulatory Expertise: Strong understanding of food safety regulations (USDA, FDA, etc.) and familiarity with fresh produce standards preferred. Audit Proficiency: Hands-on experience with Global Food Safety Initiative (GFSI) audit schemes-SQF certification preferred; exposure to other audit programs is a plus. Analytical Strength: Skilled in analyzing complex data, identifying root causes, and recommending effective, data-driven solutions. Quality Leadership: Knowledge of quality assurance methodologies within manufacturing environments; able to design, communicate, and champion continuous improvement initiatives. Technical Fluency: Proficient in Microsoft 365 (Excel, Word, PowerPoint) and comfortable with data analytics platforms such as Tableau, Power BI, or JDE. Exceptional Communicator: Excellent written and verbal communication skills; able to partner effectively across all levels and functions. Collaborative & Resilient: Thrives in fast-paced, changing environments; skilled in managing conflict, resolving issues, and leading through ambiguity. Project Management: Proven ability to manage multiple projects end-to-end and drive measurable outcomes. Flexibility: Willingness to travel up to 50%, with occasional night or weekend work as needed to support plant operations and audits. Compensation and Benefits: The base salary for this role typically ranges from $114,000 to $126,000 annually. Actual compensation will be determined based on a combination of factors, including skills, experience, expertise, and location. In addition to base pay, this position may be eligible for bonuses or other incentive programs as part of a comprehensive total rewards package, which includes: Medical, dental, and vision coverage with multiple plan options 401(k) retirement savings plan Generous paid time off and paid holidays Tuition reimbursement and professional development programs Employee discounts, wellness initiatives, and company-sponsored events Life at Bonduelle: Learn more by visiting: ***************************************
    $114k-126k yearly 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 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 24d ago
  • Manager, QC Biochemistry (Hopewell, NJ)

    Beone Medicines

    Quality manager job in Pennington, NJ

    **General Description:** Supervises staff and executes QC Biochemistry laboratory activities to support GMP manufacturing, testing and release of material, intermediates and finished products under FDA/EU regulations, applicable International Regulations, BeOne processes and procedures. Establishes and implements QC Biochemistry procedures and supports regulatory compliance inspections. Ensures efficient and effective day to day operations of the Biochemistry laboratory. **Essential Functions of the job:** + Lead the QC Biochemistry GMP laboratory through late phase activities. + Oversee QC Biochemistry laboratory related quality systems to ensure conformance with regulations and BeOne Global quality standards. + Supervise a highly efficient QC Biochemistry team. Identify and develop key talents. + Manage QC Biochemistry laboratory routine operations, including but not limited to validation, SOP revisions, specification updates, testing records, personnel training and, scheduling, etc. + Execute laboratory bench work for analytical methods such as Potency assays, Binding ELISA, Cell Culture, Residual Host Cell Protein(HCP), Residual DNA as required. + Ensure Biochemistry laboratory compliance with Environmental Health and Safety (EHS) standards. + Ensure timely completion of testing (e.g., in-process, DS release, DP release, and stability testing) to ensure timely generation and reporting of test results In support of manufacturing operations. + 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. + Manage QC Biochemistry method transfers and method validation activities, including transfer/validation strategy and approval of protocols and reports. + Ensure that the QC Biochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives. + Manage, motivate, coach and mentor direct reports. + Undertake any other duties as required. **Core** **Competencies** **, Knowledge, and Skill Requirements:** + Scientific degree (ideally in Biochemistry, molecular biology, biotechnology or related). + Minimum of 5-7 years working experience and 2 years managing laboratory analysts in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility are required. + Working knowledge and experience with Biochemistry analytical methods such as Potency assays, Binding ELISA, Cell Culture, Residual Host Cell Protein(HCP), Residual DNA as well as instruments such Incubators, Biosafety Cabinets, Plate Washers, and Microplate Readers, etc. + Knowledgeable with USP/EP and cGMP/EU GMP regulations. + Direct experience in a GMP quality control lab is a must. + 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. + Credible and confident communicator (written and verbal) at all levels. + Strong analytical and problem-solving ability. + Excellent project management skills. + Hands-on approach, with a 'can do' attitude. + Ability to prioritize, demonstrating good time management skills. + Excellent attention to detail, with the ability to work accurately in a busy and demanding environment. + Self-motivated, with the ability to work proactively using own initiative. + Committed to learning and development. **Supervisory Responsibilities:** + Supervise a highly efficient QC Biochemistry team. Identify and develop key talents. + Manage QC Biochemistry laboratory routine operations, including but not limited to validation, SOP revisions, specification updates, testing records, personnel training and scheduling, etc. + Manage QC Biochemistry method transfers and method validation activities, including transfer/validation strategy and approval of protocols and reports. + Ensure that the QC Biochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives. + Manage, motivate, coach and mentor direct reports. **Computer Skills:** + Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint). + Ability to work on a computer for extended periods of time. **Education Required:** Bachelor's Degree required in Chemistry, Biochemistry, or Biotechnology related scientific discipline and 5-7 years of working experience and 2 years managing laboratory analysts in an FDA-regulated biotechnology, pharmaceutical company are required. Master's degree in Chemistry, Biochemistry, or Biotechnology related scientific discipline and 4-5 years of working experience and 2 years managing laboratory analysts in an FDA-regulated biotechnology, pharmaceutical company are preferred. **Travel:** + Must be willing to travel approximately 10%. 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. 60d+ ago
  • Quality Control Manager (QCM), Federal Construction

    Elite Recruiting & Consulting Services

    Quality manager job in Philadelphia, PA

    Job Description Quality Control Manager (QCM), Federal Construction Columbus, GA Full-Time, Onsite, Federal Project Assignment About the Role We are seeking an experienced Quality Control Manager (QCM) to support federal government construction projects in the Columbus, GA area. This role is critical to ensuring all construction activities comply with contract documents, USACE standards, EM 385 requirements, and applicable federal regulations. The QCM will serve as the primary point of contact for quality-related matters and will work closely with the Project Manager, Superintendent, subcontractors, and government representatives. Key Responsibilities Develop, implement, and manage the Contractor Quality Control (CQC) Plan in accordance with USACE and DoD requirements Conduct and document the Three-Phase Control Process: Preparatory, Initial, and Follow-Up Inspections Review and manage submittals, RFIs, and quality documentation for compliance with contract specifications Perform daily quality control inspections across all phases of construction including civil, structural, architectural, and MEP work Prepare and submit daily QC reports, inspection logs, deficiency tracking, and corrective action documentation Coordinate and lead preparatory meetings, initial inspections, and quality coordination meetings Interface directly with Government QA personnel and participate in inspections, audits, and site walks Ensure work is executed in accordance with approved plans, specifications, and safety standards Track deficiencies, oversee corrective actions, and verify closeout compliance Support project closeout activities including punch lists, as-builts, and final inspections What We're Looking For Minimum 5 years of experience as a Quality Control Manager on federal construction projects Demonstrated experience working on USACE, NAVFAC, or other DoD projects Strong knowledge of federal construction standards, quality processes, and documentation requirements Experience coordinating with government inspectors and contracting officers Ability to manage multiple features of work and maintain organized quality records Strong communication skills and attention to detail Required Certifications & Qualifications USACE Construction Quality Management (CQM) for Contractors Certification OSHA 30-Hour Construction Safety Certification Working knowledge of EM 385-1-1 safety standards Ability to pass federal background requirements and site access credentials Valid driver's license Why Join Us? Work on stable, long-term federal government construction projects Clear scope, defined quality standards, and structured project environments Opportunity to work with experienced federal project teams Competitive compensation based on experience and certifications Total Rewards & Benefits Competitive salary or hourly compensation based on experience Per diem, lodging, and travel support if applicable Health insurance options and paid time off Consistent federal project pipeline Apply Today Qualified candidates are encouraged to apply to be considered for current and upcoming federal construction projects in the Columbus, GA area. Confidential inquiries are welcome.
    $68k-102k yearly est. 28d ago
  • Quality Control Manager

    Bristol Bay Construction Holdings LLC

    Quality manager job in Philadelphia, PA

    Job Description We are seeking an experienced dual hat Quality Control Manager & Site Safety Officer to join our SES Civil and Environmental team, a subsidiary of BBCH. The primary responsibilities of this position are to coordinate, plan, and supervise subcontractors and/or craft activities to ensure adherence to plans and specifications; enforce site safety and provide contractor quality control. This position is based in Folsom, Pennsylvania. Project Scope of Work: Interior and exterior renovation of MCRC Folsom PA, including site work, roofing, finishes, MEPs, and roofing. We are an equal-opportunity employer. All applicants will receive consideration for employment, without regard to race, color, religion, creed, national origin, gender, or gender identity, age, marital status, sexual orientation, veteran status, disability, pregnancy or parental status, or any other basis prohibited by law. We participate in the E-Verify Employment Verification Program. We are a drug-free workplace. Responsibilities: Submittal coordination and review. Updating submittal register. Inspections of materials and workmanship. USACE RMS system management and input. Safety meetings. AHA development and review. Review material and safety submittals for compliance. Supervise special inspections. Verify qualifications. Maintain rework/deficiency logs. 3 phases of inspection. Qualifications: Experience in quality control management within the federal construction industry. Ability to coordinate and review submittals, ensuring alignment with project specifications and standards. Proven track record of managing and updating submittal registers efficiently. Familiarity with the USACE RMS system for effective project management and input. Strong skills in conducting thorough inspections of materials and workmanship to uphold quality standards. Experience in developing and reviewing Activity Hazard Analyses (AHA) to ensure site safety. Ability to supervise special inspections and verify the qualifications of subcontractors and team members effectively. About Company About Bristol Bay Construction Holdings LLC: Bristol Bay Construction Holdings LLC (BBCH), a holding company of Bristol Bay Native Corporation (BBNC), an Alaska Native Corporation. The BBCH family of companies includes 8(a) small and large businesses operating under the Aerostar, CCI, CSI, Herman, and SES brands. The vision of BBCH is to be the best value company and employer of choice, recognized for our dedication to our unity of purpose, values, employees, clients, and shareholders. For three decades, our best-value companies have provided federal and commercial clients with superior quality and cost-effective, innovative, and sustainable solutions for construction, restoration services, civil works, fuel systems, environmental services, and facility support services / professional services. BBCH gives hiring, promotion, training, and retention preference to BBCH shareholders, shareholder descendants, and shareholder spouses who meet the minimum qualifications for the job.
    $68k-102k yearly est. 4d ago
  • Quality Control Senior Manager

    I.Rice & Company

    Quality manager job in Philadelphia, PA

    Job Description This permanent, full-time position supports the Quality Assurance department. The Quality Control Senior Manager plays a critical role in maintaining and enhancing our commitment to food safety and quality. This hands-on position combines leadership with technical expertise, supporting the Director of Quality Control with administering department operations, validating program CCPs, and participating in audits, while also performing daily functions in the lab. Knowledge of laboratory principles is required. Product testing includes brix, pH, water activity, titrations, viscosities and organoleptic evaluations. Environment is a clean and modern lab working with terrific people. Essential Job and Duties -Develop, implement, and manage quality systems, food safety programs, and regulatory compliance standards (HACCP, GMP, FSMA, SQF, etc.) -Coordinate with the Director of Quality Control to lead internal and external audits, including customer, third-party, and regulatory inspections -Manage record-keeping and reporting systems related to production metrics and regulatory requirements. -Assist with monitoring sanitation programs and environmental testing, ensuring compliance with microbiological and allergen control standards. Promote a clean and safe working environment where respect for coworkers and the consumer is reflected in every procedure. -Maintain and update Operations documents and SOPs -Perform analytical tests on raw materials and finished products -Calibrate laboratory equipment -Work with production to make adjustments to batches in order to adhere to product specifications -Respond to customer questions or concerns in a professional and appropriate manner -Maintain the finished goods retention library -Sample finished product for microbial analysis -Maintain raw material specification documentation and product specification documentation -Maintain finished product specification documentation Requirements -Bachelor's Degree in Food Science, R&D, or related course of study preferred -10+ years of related quality assurance or lab experience -Strong knowledge of HACCP, SQF, FDA, USDA, GFSI, SQF, FSMA, GMP, GLP, required -Food industry experience required -Ability to prioritize and organize ones work load -Ability to work in a team environment as well as individually in an environment with changing priorities -Comfortable working on an active busy production floor among batching and packaging equipment. -Ability to manage time effectively -Maintain proper lab conditions and equipment maintenance -Maintain proper record keeping and perform data entry -Be capable of working in various work settings of the facility including laboratory, office and plant areas -Perform basic math skills -Proficient computer skills, including above average knowledge of MS Excel -Understand and perform scaling/measuring in standard and metric formats -Lifting and carrying up to 50 pounds -Being able to withstand extended periods of time on one's feet -Working and walking in a wet environment
    $68k-102k yearly est. 20d 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
  • Supplier Quality Manager

    Cencora, Inc.

    Quality manager job in King of Prussia, PA

    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 26d 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 34d ago

Learn more about quality manager jobs

How much does a quality manager earn in Lower Makefield, PA?

The average quality manager in Lower Makefield, PA earns between $62,000 and $131,000 annually. This compares to the national average quality manager range of $64,000 to $128,000.

Average quality manager salary in Lower Makefield, PA

$90,000

What are the biggest employers of Quality Managers in Lower Makefield, PA?

The biggest employers of Quality Managers in Lower Makefield, PA are:
  1. SAP
  2. Dodge Construction Network
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