Quality Management Specialist II
Quality manager job in Princeton, NJ
Duration: 12 months
The Quality Management Specialist II tasks include:
CW shadows 3 ongoing studies and supports 7 ongoing studies (planning to reporting stage) to provide Quality oversight, to recommend best practices. Communicates and collaborates with the stakeholders (CM and FAs) partnering for cross-functional team support and attendance of project and study level meetings.
With the assistance of Senior GCP Level 1 members, consults on major and critical quality issues, potential Serious Breaches, significant noncompliance, data integrity issues and protocol deviations, escalates to Senior Management, and performs periodic resolution checks for assigned studies.
Supports risk assessments and risk-based approaches for the annual GQM Audit Plan, identifies the number of site audits and vendor audits based on risk-criteria with input from study teams. Provides study and site related information and documentation to the audit team, GCP Level 2 in preparation for audits.
Participates in the risk assessment of preferred and active vendors utilizing risk assessment tools to prepare the annual GQM Vendor Audit Plan.
Involved in CAPA review of Quality Issues, Audits, Inspections, eTMF audit responses.
Participates and contributes to weekly, monthly, and quarterly GQM GCP meetings.
Attends QA:QA and Quality Council meetings with CRO accompanied by a Senior Member from the GCP In-Line Quality (Level 1)
Participates in the review and harmonization process of controlled documents such as protocols/ICF, CSRs, amendments, procedural documents & templates.
Receives GCP training of ICH Guidelines E6 R3 and Modules from 21CFR and reads GCP Material. Team Members in training participate in weekly team support meetings.
Involved in the Portfolio-wide proactive Inspection Readiness support (Sponsor, Site, CRO) - conducts Do & Don't training, participates in interview preparations/debriefs, assesses Inspection Readiness Visits and Pre-Inspection Visits outcomes.
Reviews and assesses Pharmacovigilance System Master File (PSMF) and performs PV related activities as assigned.
Qualifications:
Bachelors Degree; preferably some Pharmaceutical background and GCP ICH E6 knowledge.
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit ************************
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Recruiter Details:
Name: Vicky
Email: **********************************
Internal Id: 25-54443
Director, Supply Chain Food Safety & Quality
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
Senior Editorial and Quality Lead (Healthcare Agency)
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.
Business Quality Manager, Food Service
Quality manager job in Camden, NJ
Since 1869 we've connected people through food they love. We're proud to be stewards of amazing brands that people trust. Our portfolio includes the iconic Campbell's brand, as well as Michael Angelo's, Pace, Pacific Foods, Prego, Rao's Homemade, Swanson, and V8. In our Snacks division, we have brands like Cape Cod, Goldfish, Kettle Brand, Lance, Late July, Pepperidge Farm, Snack Factory, and Snyder's of Hanover. Here, you will make a difference every day. You will be supported to build a rewarding career with opportunities to grow, innovate and inspire. Make history with us. Why Campbell's… Benefits begin on day one and include medical, dental, short and long-term disability, AD&D, and life insurance (for individual, families, and domestic partners). Employees are eligible for our matching 401(k) plan and can enroll on the first day of employment with immediate vesting. Campbell's offers unlimited sick time along with paid time off and holiday pay. If in WHQ - free access to the fitness center. Access to on-site day care (operated by Bright Horizons) and company store. Giving back to the communities where our employees work and live is very important to Campbell's. Our "Campbell's Cares" program matches employee donations and/or volunteer activity up to $1,500 annually. Campbell's has a variety of Employee Resource Groups (ERGs) to support employees.
How You Will Make History Here
At Campbell's, quality isn't just a standard-it's a promise. In this role, you'll be the driving force behind ensuring that promise is delivered across every category we touch. From snacks to beverages and beyond, you'll lead the execution of business quality programs in the field, influence innovation processes, and champion continuous improvement initiatives. Your work will directly impact consumer trust and elevate our quality standards to new heights. Location: Camden, NJ headquarters or any Campbell's manufacturing plant location.
What You Will Do
* Execute Business Quality programs and commercialization processes at the facility level.
* Support new product launches, quality improvement projects, and enabler programs through data collection, analysis, and product evaluations.
* Analyze consumer trends, complaints, and inquiries to identify opportunities for improvement.
* Develop and track key quality KPIs to measure success and drive accountability.
* Act as the primary liaison between business quality and cross-functional teams, including plant quality, supply quality, food safety, and microbiology.
* Provide training and guidance to facility teams on quality standards and procedures.
* Represent quality in meetings, troubleshoot urgent issues, and lead root cause analysis for consumer and customer complaints.
Who You Will Work With
Reporting into Global Quality leadership, this individual contributor role operates within a growing organization that oversees multiple categories. The position collaborates closely with cross-functional partners including Marketing, Supply Chain, R&D, Field QA, and Manufacturing teams.
Our team stands out for its enterprise-wide impact across diverse categories, fostering a collaborative, relationship-driven culture that values innovation and continuous improvement. We maintain a strategic focus on reducing complaints and waste while enhancing capabilities, and we offer opportunities to support commercialization and innovation projects across multiple business units.
The future of the business focuses on driving initiatives aimed at complaint reduction, waste reduction, and capability improvements, while supporting the commercialization of new innovations and enabler programs across diverse product lines.
What you will bring to the table… (Must Have)
* Bachelor's Degree in a related scientific discipline
* 3-5 years of relevant experience
* Ability to influence Marketing and R&D, manage multiple priorities, and communicate effectively across levels.
* Proficiency in Statistical Process Control, Design of Experiments, and process capability studies.
It would be great if you have… (Nice to Have)
* BS in Food Science
* 3-5 years of experience in the food industry or relevant CPG experience.
* Strong knowledge of product processing, food safety, regulatory compliance, and quality systems.
* Experience in large organizations (or adaptable from smaller/private companies).
* Plant-level experience with commercialization and quality troubleshooting.
* Familiarity with quality manuals, audit standards, and KPI development.
* Strong risk management and problem-solving capabilities.
* Continuous improvement mindset and ability to build trust quickly.
Compensation and Benefits: The target base salary range for this full-time, salaried position is between
$109,500-$157,400
Individual base pay depends on work location and additional factors such as experience, job-related skills, and relevant education or training. Total pay may include other forms of compensation. In addition, we offer competitive health, dental, 401k and wellness benefits beginning on the first day of employment. Please ask your Talent Acquisition Partner for more information about our total rewards package.
The Company is committed to providing equal opportunity for employees and qualified applicants in all aspects of the employment relationship, including consideration for employment, without regard to race, color, sex, sexual orientation, gender identity, national origin, citizenship, marital status, protected veteran status, disability, age, religion, or any other classification protected by law.
Auto-ApplyQuality Assurance & Control Manager (Electric Utility Construction)
Quality manager job in Norristown, PA
Job DescriptionSalary:
If you need assistance with the application process, please notify IB Abels Human Resources Department. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
About Us
IB Abels 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 Professionalshape 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 companys 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 Were 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.
Food Safety Quality Assurance Manager Protein (2nd Shift)
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
Director, Quality & Compliance Training (Princeton, Hybrid)
Quality manager job in Princeton, NJ
The Director, Quality & Compliance Training, is a senior leader within the Learning Center of Excellence under Global Quality. This role is responsible for developing and executing global training strategies for various functions (e.g., Commercial, Finance, HR, Legal, and other General & Administrative areas). The position ensures that learning programs drive business performance, compliance with corporate standards, and foster a culture of continuous development across the organization.
**Key Responsibilities:**
**Strategic Leadership & Governance**
+ Define and lead the global training strategy aligned with corporate objectives and quality principles.
+ Establish governance frameworks for training compliance and operational excellence, including policies and SOPs.
+ Serve as a key advisor to senior leadership on learning trends, capability-building strategies, and risk mitigation.
**Program Development & Delivery**
+ Design and oversee training programs for Commercial and G&A functions, ensuring relevance and scalability.
+ Implement innovative learning solutions leveraging adult learning principles, digital platforms, and blended learning approaches.
+ Ensure training content aligns with corporate standards and supports organizational priorities.
**Stakeholder Engagement & Collaboration**
+ Partner with functional leaders, HR, and Quality to identify learning needs and align initiatives with business goals.
+ Act as a trusted advisor to senior leadership on training effectiveness and workforce capability development.
**Continuous Improvement & Analytics**
+ Define KPIs and leverage data analytics to measure training impact and drive enhancements.
+ Stay current with industry best practices, emerging technologies, and evolving business needs to continuously improve learning programs.
**Operational Oversight**
+ Collaborate with training operations teams to ensure efficient delivery and compliance tracking.
+ Oversee vendor relationships for training services and technology solutions
**Qualifications:**
+ Bachelor's degree required; advanced degree in Life Sciences, Education, Organizational Development, or related field preferred.
+ 10+ years in pharmaceutical or life sciences industry with significant experience designing and implementing global training programs.
+ Proven track record in designing and implementing global training programs and managing cross-functional teams.
+ Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA, EMA, etc.).
+ Proven ability to design and deliver impactful learning programs using adult learning principles.
+ Experience with learning technologies (e.g., LMS, virtual learning platforms) and data-driven training strategies.
+ Excellent communication, collaboration, and stakeholder engagement skills.
**Preferred Attributes:**
+ Strategic thinker with a passion for scientific learning and development.
+ Agile and adaptable in a fast-paced, matrixed environment.
+ Strong project management and organizational skills.
+ Committed to fostering innovation, compliance, and continuous improvement through learning.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $164,530.00 - Maximum $245,985.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Quality Manager consultant
Quality manager job in Cherry Hill, NJ
AYR Global IT Solutions is a national staffing firm focused on cloud, cyber security, web application services, ERP, and BI implementations by providing proven and experienced consultants to our clients. Our competitive, transparent pricing
model and industry experience make us a top choice of Global System
Integrators and enterprise customers with federal and commercial
projects supported nationwide.
Subject: Quality Manager consultant
Location: Cherry Hill, NJ
Duration: 6+ months plus
US Citizen, GC is preferred but will accept H1.
Qualifications
Job Description: Quality Manager consultant
Responsible for leading testing and quality process for IT functions supporting car automation.
Responsible for regression testing plan and execution.
Work with business to ensure integration requirements for IT platforms are properly established and
executed.
Responsible for unit and integration test plans for IT applications.
Ensure quality metrics are established and achieved in partnership with the business owners.
High touch interaction between business and IT team members.
Additional Information
If anyone might be intersted please send resumes to kmarsh@ayrglobal (dot) com or you can reach me direct at **************
Manager, Corporate Food Safety and Quality
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: ***************************************
Manager, Corporate Food Safety and Quality
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: ***************************************
Clinical Quality Manager
Quality manager job in Collegeville, PA
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description:
The correct title for this position is Clinical Quality Manager. Role Description The Clinical Quality Manager (CQM) is responsible for driving Asset and Study level quality management for specific assets primarily in the Alliance Partner (AP) model by maintaining 'quality' line-of-sight from Asset to Clinical Investigator Site level.
• With this focus, the CQM role brings deep knowledge for asset- and study-level quality across clinical trial business process areas. In partnership with the Dev Ops Asset Lead and BU Clinical Lead, the CQM will ensure study level quality oversight, manage relevant Asset and Study level quality issues, and will be instrumental in ensuring that Asset and Study level information is appropriately incorporated within the GCP QMS. Act as point person to stakeholders and asset teams for asset and study quality risk management and quality issues management.
• CQM may also continue to provide additional centralized services as described below as necessary. Responsibilities As CQMs are assigned to specific Asset, responsibility includes: Facilitate IQMP Development and Oversight of IQMP (Integrated Quality Management Plan) at study and asset level including integration within the Quality Management System (QMS) Facilitate study-level quality risk management activities (including IQMP activity)
• Drive consistent implementation of IQMP across study-teams Facilitate IQMP development to ensure that study teams: Identify factors that are critical to quality and pre-specify appropriate quality metrics Identify high priority risks to quality and prospectively implement appropriate mitigation plans
• Facilitate IQMP implementation, via participation on the asset clinical operations team, by ensuring that quality metrics are monitored and that quality deviations are identified and addressed in a timely and appropriate manner. Utilize QMS information, and integrate findings back into QMS, share learnings across assets and across CQM team Provide feedback to IQMP BPO to continuously improve IQMP approach Quality Gate and/or Quality Compliance Assessments Perform quality gate assessments (e.g. quality, completion or compliance assessment of key quality elements (e.g. prior to study start-up, during conduct phase, and study closeout)
• Perform asset or study-focused quality compliance assessments Track compliance or performance against expectations, and manage outcomes Asset Clinical Quality Management Facilitate study-level quality risk management activities (including IQMP activity) Maintain comprehensive portfolio of quality issues across Asset Provide quality management / operational expertise Review quality reports and metrics for asset/study implications and remediation needed; to identify useful knowledge to apply/share cross-functionally IQMP PSQRV visit information for trends across asset Significant deviations/qualifying quality issues (QQI) across asset
• Audit/Inspection Metrics Audit and/or CAPA Trend reports Protocol Deviations Metrics and Trends Guide asset/study team on appropriate quality remediation actions, facilitates remediations, and tracks/ensures completion in close collaboration with DevOps Asset Lead and BU Clinical Lead (e.g. remediation for pervasive cross-asset protocol deviation issues)
• Ensure timely progress and completion for quality activities for which study teams/Alliance Partner are responsible per Clinical Trial Process Quality Standards (CTPQS): (e.g. Audit CAPA completion, study level quality issue action tracking, inspection readiness) Participates on QQI teams to provide guidance on actions to address quality issues (e.g. issuance of Protocol Deviation Alert Letters (PDAL), or actions to address QQI) May attend governance meetings and provide knowledge/trend information as appropriate
• Perform Root Cause Analysis (RCA) for ad hoc asset quality issues Participate and guide team with Inspection conduct and response activity Maintain line-of-sight to asset quality issues where studies within asset are in multiple models (e.g. AP model, Maintained portfolio) Escalation, Communication, and Governance Guides asset/study team on appropriate escalation pathways Communicates/Escalates Asset / Study quality issues to: Asset-level roles (e.g. DevOps Asset Lead, Clinical Lead) Governance committees as necessary (e.g. QCC, QOC) BPOs for process level issues Alliance Partner Quality group/roles for potential qualifying quality issues as applicable Communicates study team continuous improvement feedback on business processes to BPOs Communicates key quality information (e.g. inspection/audit learnings) across asset/study teams and may serve as asset quality expert and liaison to relevant governance meetings
• Lead or participate in quality-focused meetings for Asset Teams Perform other quality management related or oversight tasks as assigned CQMs may be responsible to provide other CQM centralized services which may include: Quality Compliance Assessments Lead / Contribute to Quality and Compliance Assessments (QCA) planning, conduct and report-out Line Compliance and SOP Review Coordinate and may manage the DevOps Compliance Plan (ADM02); ensure CTPQ training compliance Contribute to the review of new and revised SOPs to determine impact on DevOps business and compliance capability Audit Coordination Point of contact within DevOps and for internal audit groups for process audit planning, conduct and response support; may serve as DevOps/Clinical Audit Coordinator; track Dev Ops / Clinical process audit CAPAs; provide Audit Schedule Root Cause Analysis Facilitation May lead or participate in Root Cause Analysis for ad hoc requests Inspection Readiness Develop and lead strategy for and/or provide Study Team Inspection Readiness (IR) guidance and support; leads teams through pre-submission IR deep-dive Act as CQM Inspection Readiness contact for study teams via the CPM line Inspection
• Support Acts as lead point of contact or supports the lead/main CQM point of contact within DevOps and for MQA when regulatory inspections are announced Coordinates or supports coordination of resources within DevOps/Clinical to ensure successful inspection outcomes and CAPA management for inspection commitments, communicates inspection progress and needs to DevOps/Clinical stakeholders QQI/CAPA Management: Acts and/or supports CAPA Mgmt lead as business line quality group for CAPA Management of Dev Ops / Clinical CAPAs .
• Ensures or supports compliance with CAPA process QQI Case Management o Will or may function as QQI Case Lead: management for Significant Deviations, including investigation/root cause analysis and action development, tracking, and documentation Qualifications Training & Education Preferred: Degree in one of the disciplines related to drug development or business. Advanced or comprehensive knowledge, experience and expertise in clinical trial development, and operational quality management disciplines such as, quality and compliance assessments, quality assurance, CAPA management, deviation management, root cause analysis, audit and regulatory inspection process, and/or inspection readiness.
• Prior Experience Preferred Advanced or comprehensive clinical trials experience, especially operational processes and/or systems. Advanced or comprehensive Quality Management experience including use of metrics to drive quality and compliance Excellent understanding of Pharmaceutical processes and SOPs Skilled in project management Strong influencing skills with ability to influence a broad range of global stakeholders. Strong interpersonal skills and ability to build and maintain excellent working relationships across lines in a matrix organization Experience of drug development across one or more business lines Experience of working on global initiatives or project teams. Appreciation of diverse needs of different regulatory requirements of different sites and countries Ability to work successfully with internal and external partners
• Excellent communication skills adaptable to meet the needs of diverse stakeholder groups Experience of conducting, managing or participating in an audit and/or inspection process Record of achievement and delivery for personal and team goals Ability to balance and prioritize a diverse and demanding workload Works independently and proactively set own work agenda with minimum guidance Competencies: Advanced or comprehensive knowledge in clinical trial development Able to use metrics and related data to determine where quality issues may exist and address appropriately Advanced or comprehensive experience in Quality areas such as: Quality management, quality compliance assessments, audit, inspection, compliance, CAPA management, and inspection readiness fields Knowledge of Pharmaceutical process in these areas
• Project Management skills/experience Ability to provide guidance and instruction in Inspection Readiness and consultation for audit responses Knowledge of ICH GCP and regulations in order to assess GCP situations and coordinate resolution activities across partner lines Knowledge of Pharmaceutical SOPs and processes Ability to implement strategies using coordinated and transparent metrics to track and manage compliance Ability to lead cross-line global initiatives or root-cause analysis for quality related process improvement"Facilitate IQMP
• Development and Oversight of IQMP (Integrated Quality Management Plan) at study and asset level including integration within the Quality Management System (QMS) " Quality Gate and/or Quality Compliance Assessments Asset Clinical Quality Management " Advanced or comprehensive clinical trials experience, especially operational processes and/or systems.
Qualifications
Advanced or comprehensive Quality Management experience including use of metrics to drive quality and compliance Excellent understanding of Pharmaceutical processes and SOPs Skilled in project management " Skills Skills Skills:Category Name Required Experience Areas of Expertise Compliance Yes 6 + Years Technical Skills Quality Audit Reports Yes 6 + Years Additional Skills:Advanced knowledge of Clinical Trial development required. Minimum of Bachelors Degree required. Advanced degree preferred.
Additional Information
Sneha Shrivastava
Technical Recruiter (Clinical/Scientific)
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: ************ | Fax: ************
Connect with us on - LinkedIn | Facebook | Twitter
Quality Control Laboratory Manager
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.
Auto-ApplyQuality Control Manager
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.
Manager, QC Biochemistry (Hopewell, NJ)
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.
Quality Control Manager - QCM
Quality manager job in Philadelphia, PA
Bristol Bay Construction Holdings LLC (BBCH) is 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. Candidates must have strong organizational and communication skills.
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.
Submittal coordination and review
Updating submittal register
Inspections of materials and workmanship
Army Corps 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
Hold preparatory meetings with the team
USACE Quality Control Management
EM385 1-1 40hr
OSHA 30hr
10 years' experience in construction
Experience managing Government projects
Proficient in RMS, proficient with Word, Excel, and PDF
Experience with Procore
Familiar with P6 or Microsoft Project scheduling tools
Strong safety background and certs in Fall Protection, confined space, etc.
Can pass a background check
As a condition of employment, you may be required to pass a pre-employment drug screening and have acceptable references and background check results
Quality Control Senior Manager
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
Supplier Quality Manager
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.
Supplier Quality Manager
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
Auto-ApplyInternational QC Manager
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
Supplier Quality Manager
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.