Quality Assurance Manager
Quality assurance manager job in Cherry Hill, NJ
JOB PURPOSE :
Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that materials and products are inspected and released in compliance with cGMP guidelines, USP and FDA, EU requirements. Responsible for first shift QA In-Process and In-coming Groups, getting all the QA batch record documents approved for timely release of finished products and timely release of incoming materials.
Work closely with Operations (Filling and Packaging) and other groups as necessary to troubleshoot issues in the warehouse, filling and packaging floors and ensure timely reporting of events. Work closely with compliance group at times of external audits (FDA or vendors). Ensure that non-compliant situations are thoroughly investigated.
KEY ACCOUNTABILITIES:
Regular and predictable onsite attendance and punctuality.
Directs the incoming and in-process QA groups. Makes final accept/reject disposition on incoming materials, including but not limited to raw materials, components, production commodities. Assures batch is manufactured Ensures that records are reviewed and released in a timely manner.
Coordinates communication for status of incoming materials and resolves issues related to accept/reject disposition of materials.
Coordinates communication of production status to next shift; attends daily update meetings as required.
Manages personnel for in-process filling and inspection/packaging monitoring.
Provides QA review and approval of manufacturing investigations, as necessary, assuring timely review, follow-up, tracking and trending of MIRs. Provide guidance to the investigator, as required
Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR's, Commissioning Documents, FAT's), engineering documents.
Expedites and prioritizes product releases by coordinating the Review of QA documentation to meet customer service requirements.
Conducts routine investigation and departmental meetings to facilitate the performance of release function, with respect to incoming materials.
Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff.
Places lots on HOLD if Quality issues are detected and notifies senior management.
Assists the QA management in developing on department budget.
Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions.
Manages attendance records for all direct reports.
QUALIFICATIONS:
College Degree within a science related discipline such as a B.S. in Pharmacy, Science, Engineering or other related fields is required with 10+ years' experience, or Masters' Degree in Microbiology, or biological science with 3-6 years' experience
Ph.D. in relevant field with 0-3 years' experience
Preferred: Additional college courses in Microbiology, cGMPs, Statistics or Quality Management are beneficial
EXPERIENCE:
Minimum: Experience in the Pharmaceutical Industry in the field of Quality Assurance or Production is a must
SKILLS:
Must have history of strong documentation skills and attention to detail
Familiarity with cGMPs and CFR for US and EU
Excellent organizational skills and ability to multi-task and perform work in a timely manner
Demonstrates ability to lead a department, projects and meetings effectively
Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management
General computer skills and ability to prepare presentations and address large groups
Demonstrated attention to details and accuracy
The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must
Mentoring abilities as well as effective communication, (written and oral) are required.
What We Offer*:
Annual performance bonus, commission, and share potential
Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
3 personal days (prorated based on hire date)
11 company paid holidays
Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
Employee discount program
Wellbeing rewards program
Safety and Quality is a top organizational priority
Career advancement and growth opportunities
Tuition reimbursement
Paid maternity and parental leave
*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.
Quality Project Manager
Quality assurance manager job in Horsham, PA
This position will lead and participate in projects for the integration of new products into systems that impact the US Pharm Local Operating Company (LOC) and Deliver organizations. Open to candidates located in Horsham PA or Titusville NJ.
Responsibilities:
Key responsibilities include, but are not limited to:
Projects (100%)
Provide project leadership and support related to quality systems for US Pharm CQ and US Deliver initiatives.
Complete GMP documentation to ensure compliance.
Track completion of project deliverables.
Coordinate and collaborate with project team members.
Propose process improvements.
Provide routine project updates.
Perform additional tasks as needed to support project deliverables.
Others:
Execute compliance activities on behalf of team leadership, including but not limited to the creation and revision of regional and local procedures and/or work instructions.
Escalate appropriate issues to management.
Make quality decisions based on assessments of compliance risks, balanced with overall business needs.
Drive strategic initiatives for both CQ and distribution centers.
Ensure strategies are implemented and closed out in a compliant and timely manner.
Experience:
Minimum of 3 years' experience in the Medical Device, Pharmaceutical, or Consumer Products industry.
Experience working in a highly regulated industry.
Proven experience leading projects and influencing team members to achieve results without direct supervision.
Strong written and verbal communication skills, with the ability to take initiative independently as well as collaborate as part of a team.
Demonstrated problem-solving, decision-making, data analysis, inductive reasoning, critical thinking, and root cause analysis skills.
Excellent communication and presentation skills.
Strong change management, collaboration, and influencing skills to effectively partner across functions.
Ability to work under tight timelines and maintain customer focus.
Must be able to manage and provide leadership across multiple sites.
Advanced proficiency in PowerPoint and Microsoft Excel, including VLOOKUPs and pivot tables.
Demonstrated flexibility to handle complexity and multiple initiatives.
Proven ability to successfully partner and collaborate with business partners outside of Quality.
Experience interpreting compliance requirements and regulations.
Preferred Skills and Experience:
Project Management certifications.
Understanding of FDA 21 CFR Part 210, 211, ISO 9001 and/or ISO 13485.
Understanding of Installation Qualification, Operational Qualification, Process Qualification (IQ, OQ, PQ), and associated report writing.
Familiarity with Comet.
Skills:
Project Management
Biomedical Industry
Pharmaceutical Regulatory Compliance
Education:
Bachelor's/University degree.
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: Azhar
Email: ****************************
Internal Id: 25-53768
Quality Assurance Manager
Quality assurance manager job in Philadelphia, PA
Quality Assurance Manager - FOOD MANUFACTURER
Salary $100,000 - $115,000 + Bonus + Excellent Benefits + Paid Relocation to the NE USA
Growing food manufacturer is seeking a Quality Assurance Manager for their Food Manufacturing facility. We need a talented Quality Assurance Manager who will collaborate with Operations in building a world-class food safety and quality culture.
As Quality Assurance Manager, you would provide leadership within the facility to drive positive changes through influence and example. You'll need to have dairy industry experience, be able to develop and maintain the facility systems and processes to ensure the finished product is food safe and meets finished product specifications.
Minimum requirements for this Quality Assurance Manager's position:
· Bachelor's degree required in Food Science, Biological Sciences or related field
· At least 3 years of experience in QA management in the dairy industry
· Certification and/or Licenses
o HACCP certification
o SQF Practitioner certified or obtain within first 90 days
o PQCI certification.
Manager, Microbiology
Quality assurance manager job in Burlington, NJ
Job Title: Microbiology, Manager
The Microbiology Manager is responsible for overseeing the daily operations of the Microbiology laboratory and leading strategic planning for the lab and its staff. This individual serves as the subject matter expert on contamination control and microbiological testing of parenteral drug products. The role involves significant participation in customer and regulatory audits, client interactions, site metrics meetings, site-wide improvement projects, budgeting, and data review and interpretation, including protocols, investigations, and laboratory documentation. The manager is accountable for the entire laboratory team and handles staff management duties such as performance reviews, disciplinary actions, and ensuring proper training. Operating with limited supervision, this position requires the ability to work independently as well as collaboratively on cross-functional teams.
Essential Duties and Responsibilities:
Develop and maintain leader standard work in the laboratory
Align and maintain staff shift schedules with required manufacturing support functions
Demonstrate expertise in CGMP guidelines, ISO 17025, and USP microbiological testing, especially USP , , , , , and
Maintain laboratory policy and procedure manuals; assist in developing and validating procedures and document preparation
Ensure timely completion of projects, CAPAs, and investigations
Manage, conduct, and/or delegate the final review and approval of environmental and microbiological test results, including those from contract labs, to support lot disposition and deliverables as prioritized by site leadership
Oversee compliance guideline reviews, industry trend assessments, customer projects (method transfer, development, etc.), validation efforts, expansion projects, and continuous improvement initiatives
Act as SME to lead collaboration between departments to trend and continuously improve site Contamination Control Strategy and Environmental Monitoring Program
Represent the department during regulatory, customer, and internal audits; ensure timely response to audit observations and execution of related CAPAs
Develop and execute training on laboratory methods, instrumentation, and aseptic technique
Build and evolve the department Training Matrix to align with industry standards and best practices
Write and revise Microbiology and other relevant SOPs as required
Provide technical input on product testing issues and instrumentation/equipment
Ensure laboratory compliance with cGMP through inspections of monitoring systems and equipment
Ensure proper recording and review of data
Test the integrity of raw materials or finished products
Conduct and document failure and complaint investigations
Serve as liaison to service, calibration, and technical representatives
Facilitate revision and release of controlled documents
Facilitate mandatory reviews of SOPs and month-end reports
Provide oversight for projects to update/maintain official document templates
Direct and manage the Change Control System
Read and interpret SOPs to ensure compliance
Maintain up-to-date training records
Perform other duties as assigned
Education and/or Experience:
Bachelor's Degree in Microbiology or related field
Minimum of five (5) years of experience in microbiology or related field within a GMP-regulated environment
Minimum of two (2) years of experience in a microbiology leadership role
Previous experience with pharmaceutical cleanroom environments
Knowledge of 21 CFR 211 and EU Annex 1 cGMP requirements
Preferred Experience:
Five (5) years of experience in a microbiology leadership role
Five (5) years of microbiology laboratory experience within a GMP-regulated setting
Supervisory Responsibilities:
This role is responsible for leading and supporting a team, overseeing day-to-day operations, managing departmental goals, and ensuring adherence to organizational policies and procedures. It also involves fostering a positive work environment, providing guidance and support to team members, and evaluating performance to drive continuous improvement and achieve both departmental and organizational objectives.
Language Skills:
The ideal candidate should have the ability to read and interpret various documents, including safety instructions, standard operating procedures, technical procedures, and governmental regulations. Strong written and verbal communication skills are essential, along with effective presentation skills to successfully present information and respond to questions from managers, clients, customers, and the general public.
Quality Control Stability Supervisor
Quality assurance manager job in West Deptford, NJ
Discover Veranova: At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference.
Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation.
Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients.
Role Overview:
The Stability Supervisor plays a key role in ensuring our stability program is executed accurately, safely, and in full compliance with internal and regulatory standards. This role supports the QC Manager in driving departmental goals, fostering a culture of continuous improvement, and developing team capabilities. It's an opportunity to make a meaningful impact on quality, reliability, and operational excellence.
Core Responsibilities:
Assign daily tasks to the stability chemists to meet stability testing schedule.
Test stability samples as needed.
Maintain safety and quality systems in a state of audit readiness.
Works with cross-functional teams (production, quality assurance, regulatory, commercial, project management, etc.) to support product campaigns defining stability requirements.
Leads laboratory investigations, identifying root causes and enacting effective CAPAs to improve overall laboratory performance (%RFT).
Develops direct reporting chemists through goal setting, performance management with regular review (i.e. 1 on1 meetings).
Reviews analytical data as required and writes necessary reports this includes stability summary reports.
Executes safety initiatives in the laboratory the maintain and improve work environment.
Updates relevant SOPs along with evaluation of current and new equipment or use in the laboratory.
Involved with laboratory audits through laboratory walkthroughs responding to auditor request/questions.
Implements and applies cGMP concepts in association with department specific responsibilities.
Helps QC Manager develop yearly budget and CAPEX plan to support future lab equipment and resource needs.
Qualifications:
Required
Bachelor's degree in chemistry or related science
Minimum of 5 years cGMP laboratory experience
Minimum of 3 years stability program experience
Ability to communicate effectively with impact internally and externally
Builds collaborative relationships cross-departmentally
Seeks opportunities for continuous improvement
Able to make decisions after evaluating current laboratory workload
Adaptability due to changing production demands due to customer needs
Preferred
Proficiency in standard QC laboratory equipment (HPLC, GC, FTIR, UV, KF, etc.)
Adept at report writing and root cause analysis
Background in data trending
Supervisory experience/leading teams
Salary Range : $90,000 - $100,000 annual base salary
Our Commitment:
Health & Wellness: Comprehensive health & wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies.
Financial Wellness: Veranova is committed to fair and transparent compensation practices. This includes a competitive base salary, eligibility for performance-based bonuses, and an attractive 401(k) Plan with company match. Salary ranges reflect the scope and expectations of the role, and are based on market data, internal equity, and role-specific factors. Final compensation may vary depending on experience, skills, education, and business needs.
Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.
Inclusive Culture: At Veranova, an inclusive culture is integral to our values. We welcome people with diverse experiences and perspectives who share our mission to improve and save lives. Even if you don't meet every qualification, we encourage you to apply. Veterans, first responders, and those transitioning from military to civilian life bring valuable skills that strengthen our team.
Additional Information:
Applicants for this role must be authorized to work in the United States without further employer sponsorship.
Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting.
All your information will be kept confidential according to EEO guidelines.
Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.
All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice .
Field Quality Assurance Compliance Auditor - Manufacturing
Quality assurance manager job in Malvern, PA
FM Approvals is an international leader in third-party testing and certification services. We test property loss prevention products and services-for use in commercial and industrial facilities-to verify they meet rigorous loss prevention standards of quality, technical integrity and performance. How? By employing a worldwide certification process that's backed by scientific research and testing, and over a century of experience.
The FM APPROVED mark is recognized and respected worldwide. Our certification instills confidence and commands respect in your marketplace.
Visit our website to learn more about FM Approvals and the amazing work our team does!
FM Approvals Website
Summary
A mid-level auditor position within the Auditing and Quality Assurance department. The role of the Quality Auditor is expected to independently schedule and conduct conformity assessment audits at customer locations. Audits include various manufacturers responsible for producing products for compliance with FM Approvals requirements. FM Approved products cover a wide range of electrical, fire protection, and building materials equipment. The incumbent is expected to possess a solid auditing foundation with a demonstrated proficiency in conducting conformity assessment audits.
This role will support a team of dedicated auditors who focus on conducting customer at location onsite compliance audits. The role requires approximately 70% travel, and 30% travel may require overnight stays.
Schedule & Location
This is a full time field position conducting surveillance audits in Malvern, PA and Maryland surrounding areas. The role requires approximately 70% travel and 30% of travel may require overnight flexibility.
Two times per year travel is required to the Malvern, PA office for corporate meetings.
Conduct on-site audits of manufacturing facilities to verify compliance with FM Approvals requirements.
Review technical documentation, product markings, inspection equipment, and calibration records for compliance.
Deliver clear, professional audit reports and communicate findings with all stakeholders.
Build strong relationships with manufacturers by managing customer interactions and maintaining integrity, impartiality and confidentiality throughout the audit process.
Document facts and observations to support audit findings and conclusions.
Efficiently manage audit schedules.
Bachelor's Degree in one of the following disciplines: Electrical, Mechanical, Chemical, Industrial Engineering or a science-based equivalent degree
5+ years of manufacturing process experience
5+ years of related quality assurance and quality auditing experience
Possess strong organizational, critical thinking, analytical and problem-solving skills
A strong communicator-both written and verbal-with excellent interpersonal skills
Valid driver's license required
Required Skills
Self-motivated and detail-driven professional with a passion for quality and compliance
Experienced in manufacturing, quality control, and audit practices.
Comfortable working independently and managing your own schedule.
Tenured audit experience with demonstrated proficiency performing conformity assessment audits
Ability to obtain and assess objective evidence throughout the audit process while acting impartially and maintaining confidentiality
Observe, document, and evaluate audit observations while effectively managing customer interactions throughout the audit process
Possess critical thinking, analytical and problem-solving skills
Computer literacy with demonstrated proficiency in Microsoft Office Suite
Experience with various measurement tools such as pressure gauges, calipers, voltmeters, etc.
Ability to read and interpret engineering technical drawings
Preferred Skills
Lead Auditor, Quality Engineer, or Quality Manager
Supplier Quality Engineer, (SQE), experience
ASQ certifications such as CQA, CQE, or equivalent
Lead Auditor Certification
Familiarity with CSA/UL/TUV or equivalent regulations and standards
Familiarity with ISO 9001 or equivalent Quality Management Systems
The hiring range for this position is $72,160-$103,700 annually. The final salary offer will vary based on individual education, skills, and experience. The position is eligible to participate in FM's comprehensive Total Rewards program that includes an incentive plan, generous health and well-being programs, a 401(k) and pension plan, career development opportunities, tuition reimbursement, flexible work, time off allowances and much more.
FM is an Equal Opportunity Employer and is committed to attracting, developing, and retaining a diverse workforce.
Auto-ApplyQuality Assurance & Control Manager (Electric Utility Construction)
Quality assurance manager job in Philadelphia, PA
If you need assistance with the application process, please notify IB Abel's Human Resources Department. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
About Us
IB Abel's 110-year history is a testament to its adaptability, forward-thinking leadership, commitment to safety, and stellar service and project delivery process. Our core values-Responsible, Integrity, Results-Oriented, Ownership, and Professional-shape everything that we do at all levels of the company and are purposefully incorporated into all company communications, meetings, and strategic planning. Our use of the EOS model (Entrepreneurial Operating System) also provides structure and clarity among all levels of the company to maintain focus on our shared goals.
IB Abel (IBA) is committed to providing ample learning and career development opportunities to its team members via our Associate's Program in Project Management, Estimating, and Accounting and our growing Learning Management System.
The Opportunity
We are seeking an experienced Quality Assurance Manager who is responsible for establishing, implementing, and maintaining the company's Quality Assurance and Quality Control program across all transmission, distribution, substation, and civil construction projects. This role ensures all work is performed to contract requirements, industry standards, and customer specifications. The QA/QC Manager partners closely with Safety, Operations, Project Management, and Field Leadership to drive consistency, reduce rework, promote right-first-time execution, and support a culture of continuous improvement.
Key Responsibilities
Quality Program Leadership -
Develop, implement, and manage the company-wide QA/QC program tailored for utility construction (T&D, substation, and civil); establish quality standards, inspection processes, checklists, and documentation that align with utility customer requirements; and maintain quality manuals, procedures, and work instructions in alignment with industry best practices.
Project Support & Field Oversight -
Conduct field QA/QC audits, inspections, and work observations to verify compliance with engineered drawings, specifications, construction standards, and work methods; ensure crews understand and apply proper installation practices for poles, structures, conductors, and all related civil work; support project teams in interpreting drawings, standards, and technical requirements; and review and approve ITPs (Inspection & Test Plans), hold points, material submittals, and commissioning documentation.
Documentation & Reporting -
Maintain accurate QA/QC records, including inspection reports, NCRs (Non-Conformance Reports), corrective actions, testing results, photos, and QA/QC logs; prepare quality reports for leadership and customers, identifying trends, recurring deficiencies, and recommended improvements; and oversee turnover documentation and quality packages for customers.
Non-Conformance & Corrective Action -
Lead investigations into quality-related issues, rework events, or specification deviations; develop corrective and preventive action plans with field leadership and project teams; and track closure of NCRs to ensure accountability and lessons learned.
Training & Continuous Improvement -
Deliver training for foremen, line workers, operators, and civil crews on quality standards and proper installation techniques; support onboarding of new field leaders by reinforcing customer-specific construction standards; collaborate with Safety, Operations, and L&D to develop technical guidance, SOPs, and best practices; and lead quality-focused continuous improvement initiatives to reduce defects and rework.
Customer & Regulatory Interface -
Serve as the QA/QC point of contact for utility clients, inspectors, and third-party engineering firms; coordinate with customer QA reps, attend pre-construction meetings, and support project QC reviews; and ensure compliance with all customer requirements, environmental guidelines, and applicable regulatory standards.
Who We're Looking For
An acceptable combination of education and/or work experience including 7+ years of experience in electric utility construction (transmission, distribution, or substation) as well as 3+ years in a QA/QC, construction management, or field leadership role.
Experience with civil construction related to utility infrastructure (foundations, excavation, concrete, site work).
Familiarity with utility standards (e.g., IEEE, NESC, ASTM, utility-specific specifications).
Proficient in quality documentation systems such as SiteDocs, Aclaimant, Procore, or similar.
Local to Pennsylvania but with regular travel to other offices, customer facilities, jobsites and yard locations for offsite meetings (flexibility to work from home when appropriate).
A “can-do” attitude, strong work ethic, excellent attention to detail, and ability to collaborate effectively with various teams.
Why Choose IBA
Culture of Growth: Many of our leaders started in entry-level field roles and advanced within the company.
Flexibility & Autonomy: We empower our team to succeed without micromanagement.
Competitive Compensation & Benefits: Includes competitive salary, vehicle allowance program, 401(k) with company matching, tuition reimbursement, and comprehensive benefits package including medical, dental, and vision.
Stability & Variety: Work for multi-generational family-oriented business on diverse, fast-paced projects without the stress of a large corporate structure.
Incentives: Performance-based bonuses/incentives and a progressive PTO programs that grows with your tenure!
Collaboration: A team environment where we work together to solve challenges and celebrate wins.
Step Into a Career That Powers the Future!
IB Abel is an equal opportunity employer, all qualified applicants are encouraged to apply.
Director, Clinical Quality Assurance
Quality assurance manager job in Philadelphia, PA
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
Director, Clinical Quality Assurance
The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH).
Essential Functions
* Independently conduct audits
* Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits
* Facilitate Sponsor health authority inspections of global clinical facilities and study sites
* Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs
* Direct skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies.
* May be responsible for direct people management including goal setting, performance management, development, and engagement.
Requirements
* Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area.
* 5+ years of experience in GCP auditing.
* Substantial experience in inspection management.
* Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials.
* Demonstrated ability to operate and influence decision-making processes
* Effective communication skills
* Successful track record of supervising employees and managing cross-cultural differences
* Technical and administrative capabilities to independently carry out routine, complex and for-cause audits
* Knowledge of data integrity controls and systems quality for clinical area
* Strong analytical skills and report writing skills
* Experience with GxP systems including computer system validation and associated regulations, recommended.
* Ability to Travel (approximately 20%)
* Candidates near Eisai's NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities.
Eisai Salary Transparency Language:
The base salary range for the Director, Clinical Quality Assurance is from :195,000-256,000
Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ***********************************************
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
Auto-ApplySAP Quality Management/Manufacturing Manager - Chemicals Industry
Quality assurance manager job in Philadelphia, PA
We Are: Are you ready to step into the heart of digital transformation in one of the world's most critical - and most dynamic - industries? The Chemicals Industry is evolving at lightspeed: demand for sustainability-driven products is on the rise. At the same time, digital platforms, real-time analytics, AI, and SAP-enabled processes are no longer "nice to have" - they are foundational.
As part of Accenture's SAP Chemical's Practice, you'll be delivering major SAP engagements (for example, Business Transformation Strategy & Roadmaps, migrations to SAP S/4HANA, process standardization, cloud-enablement) that help clients win in this new environment and guide major Chemical clients through the journey of business-model reinvention, process excellence and enterprise technology enablement
You Are:
Do you have a passion for storytelling and for originating, selling and delivering SAP-based Supply Chain Transformation projects that make a positive impact in your clients' business? Are you inspired by working with the best companies in their industries? Want a role that provides you with a sense of purpose and satisfaction?
Then join Accenture and build a rewarding career improving the way the world works and lives, as you help clients innovate with leading-edge SAP and Accenture Supply Chain solutions and technologies on some of the most innovative projects in the world
You will thrive in our highly collaborative, digitally-driven and innovation-led environment while nurturing your talent for thoughtful and game changing solutions in our inclusive culture that values diversity of ideas, experiences and backgrounds.
Ultimately, you are a confident manager who spots and stays ahead of the SAP platform, industry and Supply Chain trends and knows how to translate client goals into clear and actionable outcomes that everyone can get behind. You know how to fully utilize the capabilities of various SAP platforms to drive business value, transform end-to-end functions and drive leading practices for your clients in markets all over the globe. The more complex their challenges, the more excited you are about leading the charge to solve them.
The Work:
Team with clients on their SAP functional transformation programs through your combined SAP application and functional process expertise which includes your ability to:
+ Engage with client executives on the business challenges/trends and the potential value of SAP solutions (current & future)
+ Lead customers in defining their SAP journey through the development of business cases & roadmaps including during sales origination, proposal development and client presentations
+ Architect E2E solutions that leverage SAP technologies, custom apps, & add on partner solutions
+ Advise, design and deliver solutions based on the latest industry and technology best practices leveraging a SAP solutions and embedded innovation.
+ Lead small teams - helping them achieve transformational roadmaps - onsite with clients or within Accenture
+ Become a trusted expert and advisor to your clients, team, and Accenture Leadership by staying current on regulations, trends, and innovations across your area of expertise
+ Be a thought leader, build assets and best practices and develop the next level of transformation experts
Travel may be required for this role. The amount of travel will vary from 0 to 100% depending on business need and client requirements
Here's what you need:
+ Minimum of 5 years of SAP functional and technical experience/expertise in Quality Management and/or Manufacturing.
+ Minimum 3 years of experience in SAP projects supporting Chemicals clients. (SAP support / managed services experience will not be considered for this requirement)
+ Minimum 2 end-to-end SAP S/4 implementations, including project planning, estimation and solution architecture for Chemicals clients
+ Experience managing SAP delivery teams, in a Global Delivery Model, including but not limited to the following responsibilities: driving complex workshops and leading design decisions, as well as leading the design and execution of system build, configuration, testing, cutover, and go-live in the SAP Transportation Management or Quality Management area
+ Prior experience in a Consulting and/or Advisory role
+ Bachelor's degree or equivalent (minimum 12 years' work experience). If Associate's Degree, must have equivalent minimum 6-year work experience
Compensation at Accenture varies depending on a wide array of factors, which may include but are not limited to the specific office location, role, skill set, and level of experience. As required by local law, Accenture provides a reasonable range of compensation for roles that may be hired as set forth below. We accept applications on an on-going basis and there is no fixed deadline to apply.
Information on benefits is here. (************************************************************
Role Location Annual Salary Range
California $94,400 to $293,800
Cleveland $87,400 to $235,000
Colorado $94,400 to $253,800
District of Columbia $100,500 to $270,300
Illinois $87,400 to $253,800
Maryland $94,400 to $253,800
Massachusetts $94,400 to $270,300
Minnesota $94,400 to $253,800
New York/New Jersey $87,400 to $293,800
Washington $100,500 to $270,300
Requesting an Accommodation
Accenture is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Accenture and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.
If you would like to be considered for employment opportunities with Accenture and have accommodation needs such as for a disability or religious observance, please call us toll free at **************** or send us an email or speak with your recruiter.
Equal Employment Opportunity Statement
We believe that no one should be discriminated against because of their differences. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities.
For details, view a copy of the Accenture Equal Opportunity Statement (********************************************************************************************************************************************
Accenture is an EEO and Affirmative Action Employer of Veterans/Individuals with Disabilities.
Accenture is committed to providing veteran employment opportunities to our service men and women.
Other Employment Statements
Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States.
Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.
Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process. Further, at Accenture a criminal conviction history is not an absolute bar to employment.
The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. Additionally, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the Company's legal duty to furnish information.
California requires additional notifications for applicants and employees. If you are a California resident, live in or plan to work from Los Angeles County upon being hired for this position, please click here for additional important information.
Please read Accenture's Recruiting and Hiring Statement for more information on how we process your data during the Recruiting and Hiring process.
Quality Control Manager
Quality assurance manager job in Paulsboro, NJ
Job Description
Discover Veranova:
At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference.
Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation.
Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients.
Role Overview:
The QC Manager is responsible for the management of all quality control testing of raw materials, intermediates and final products (including stability testing) at the West Deptford site. This includes test methodology and documentation required for quality control within government, customer and industrial specifications. The incumbent works closely with quality assurance to ensure that products meet and/or exceed applicable FDA and cGMP standards. This position also works closely with development, production and with customers to ensure that all products meet required specifications.
Core Responsibilities:
Manage the resources of the Quality Control functions, cGMP systems to ensure products are consistently manufactured and tested according to the cGMP standards.
Provides appropriate coaching and performance feedback to all direct reports and assures that all team members are being developed. Manages staff in full compliance with cGMP requirements.
Responsible for the Quality Control Department budget and its control.
Maintain active customer and governmental contacts concerning technical problems and product compliance and performance.
Manages compliance with state and federal regulations, including but not limited to EPA, DEP, and OSHA, etc.
Assure all testing procedures are written, validated, and maintained.
Monitor and direct all quality control activities, which includes but is not limit too, staff scheduling, prioritization of department's work, product team participation, and determination of projects as needed for continuous improvement.
Leads quality control investigations and determines root cause to provide effective resolutions, such as CAPA's.
Responsible for the overall release/results of materials from the lab.
Evaluates metrics to develop/implement efficiency improvements.
May perform all work associated with Quality Control Chemist duties to meet the department needs.
Qualifications:
Required
BS Chemistry or related science
Minimum of ten (10) years' direct experience in organic analytical/instrumentation chemistry
Minimum of seven (7) years direct experience in organic analytical/instrumentation chemistry lab supervision.
Preferred
Chromatography background
Salary Range: $120,000 - $145,000 annual base salary
Our Commitment:
Health & Wellness: Comprehensive health & Wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies.
Financial Wellness: Veranova is committed to fair and transparent compensation practices. This includes a competitive base salary, eligibility for performance-based bonuses, and an attractive 401(k) Plan with company match. Salary ranges reflect the scope and expectations of the role, and are based on market data, internal equity, and role-specific factors. Final compensation may vary depending on experience, skills, education, and business needs.
Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.
Inclusive Culture: At Veranova, an inclusive culture is integral to our values. We are committed to ensuring that everyone can bring their full self to work and thrive in their career.
How to Apply:
At Veranova, we are on a misson to meet people that believe in our values and can contribute to the team in a variety of ways. Please visit **************** to view all open roles and join our Talent Community to stay connected and learn about opportunities as they arise.
We value a range of experiences and perspectives. If you want to be part of improving and saving the lives of patients, we encourage you to apply regardless of whether you meet every qualification listed.
Additional Information:
Applicants for this role must be authorized to work in the United States without further employer sponsorship.
Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting.
All your information will be kept confidential according to EEO guidelines.
Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.
All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.
Quality Control Senior Manager
Quality assurance 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
Quality Control Manager - QCM
Quality assurance 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 Manager (South NJ/PA)
Quality assurance manager job in Philadelphia, PA
Job Description
With a projected 1,000 cafes in the United States by 2030, Paris Baguette is one of the fastest-growing neighborhood bakery cafés in the world. Our vision is to reestablish the neighborhood bakery café as the heart of the community around the world. Paris Baguette's mission is to bring expertly crafted baked and brewed goods through a warm and welcoming bakery café experience that delivers joy to everyone.
If you are someone who has heart, wants to spread joy, nourish community and is ready to rise to the occasion, we are looking for you to join our growing team!
WHAT WE ARE HUNGRY FOR
The position of Quality Control Manager is responsible for auditing Paris Baguette's standards for all our food, baked products, and beverages while ensuring all-around quality assurance for such products across all of our cafes, with an emphasis on ensuring compliance to company policies and procedures, food safety standards, government regulations, and following up that we are using best practice standards and continually improving programs in place.
KNOWLEDGE AND RESPONSIBILITIES
Champion adherence of all elements of the food safety and quality roadmap to ensure integration in all cafes.
Coach and advise the café teams to ensure an adherence to all Company standards regarding quality.
Monitor progress on opportunities and follow up with café teams to ensure corrective actions are taken to address issues where needed.
Partner with café production teams and district production managers to provide any necessary feedback to ensure consistency in production standards.
Address non-compliance concerns by supporting district managers and district production managers with follow up suggestions for corrective actions needed in cafes based on assessments and visits.
Support café production teams and District Production Managers by reinforcing updates and product specification changes as necessary.
Audit external suppliers for food safety, food quality, and ingredient specification compliance.
Inspect ingredients, packaging materials, and finished products for compliance with company standards and specifications.
Help conduct studies to identify problems, potential problems, or continuous improvement opportunities relating to food quality and food safety.
Utilize data collection, trend information, and analysis to drive continuous improvement
Format and compose weekly, monthly and annual QC quality and food safety reports
Performs other related duties and special projects as assigned
WHAT YOU NEED TO HAVE
Related bachelor's degree, preferably in Food Science, Engineering or Business Administration
At least 1-2 years' relevant experience
Knowledge of food production processes, sanitation, quality programs
Knowledge of food production techniques, food microbiology and food sanitary safety practices and procedures
Flexible, adaptive, upbeat, open and visible work style, with a successful track record of supporting operations leaders across a large geographically decentralized portfolio.
Passion for people! Dynamic and engaged leader who has a passion for empowering, inspiring, motivating & developing team members and franchisee relationships.
Exceptional organizational and communication skills with the ability to effectively balance priorities and deliver results in a fast-paced, ever-changing, and highly entrepreneurial environment.
Feedback is a gift! Ability to provide constructive feedback and recognition to every member of the organization, along with Franchisees, to ensure we have an open and transparent culture of high-performance standards.
High emotional intelligence with the ability to work with, and support diverse teams by being highly empathetic, intuitive, self-motivated and driven.
Teams Win! Has to be a team player who fosters a collaborative and engaged teamwork environment.
Being a Brand Ambassador, with an excellent knowledge of and commitment to Paris Baguette's Mission, Vision, Brand Values and Culture.
Love of travel! Ability to commute to all current Corporate and Franchise locations, as well as proposed openings.
SWEET BENEFITS
Competitive compensation
Free Cake for your Birthday
Medical, Dental, Vision benefits
401K Retirement Plan
Paid time off, paid Holidays
High Performance Culture
Quality Control Manager
Quality assurance manager job in Wilmington, DE
About Your Opportunity: Wohlsen Construction is seeking a highly skilled and certified Quality Control Manager (QCM) for a pivotal role on our Amtrak project. This part-time position will be responsible for overseeing and ensuring the highest standards of quality control throughout the duration of the project. As the Quality Control Manager, you will play a crucial role in maintaining the integrity and excellence of our construction processes, ensuring all work meets or exceeds project specifications and industry standards.
How You'll Contribute:
Oversee and administer the Quality Control (QC) program for the project, ensuring all procedures and standards are followed effectively.
Maintain thorough documentation of QC processes, inspections, and corrective actions.
Attain and maintain certification as a Quality Control Manager through an accredited organization such as ABC (Associated Builders and Contractors), AGC (Associated General Contractors), or USACE (U.S. Army Corps of Engineers).
Ensure compliance with all relevant quality control guidelines and contractual requirements.
Monitor and enforce adherence to the QC program among Wohlsen's trade partners and subcontractors.
Provide guidance and training to trade partners on quality standards and practices.
Conduct regular inspections of materials, workmanship, and installed systems to ensure compliance with project specifications and the QC program.
Identify and document any non-conformance or defects, coordinating with trade partners to facilitate timely re-work and resolution.
Confirm that approved submittals for materials and equipment are installed correctly and in accordance with contract requirements and QC standards.
Review and validate all submittals to ensure quality and compliance before installation.
Prepare and present detailed quality control reports, including findings from inspections, corrective actions taken, and overall quality status of the project.
Collaborate with project management and other stakeholders to address any quality issues and implement improvements as needed.
Identify opportunities for improving the quality control process and implement best practices.
Stay updated on industry trends, standards, and technological advancements to enhance the QC program.
Relationships
Reports to Project Executive
Works alongside the Project Team
Authority
Authorized to approve or reject materials, equipment, and workmanship based on quality standards and correct requirements.
Responsible for enforcing adherence to the QC program among trade partners and subcontractors, including issuing directives for non-compliance.
Empowered to conduct inspections and audits and generate quality control reports for project management.
Accountability
Accountable for the overall effectiveness and administration of the Quality Control Program, ensuring it meets project specifications and industry standards.
Responsible for identifying, documenting, and addressing quality issues, including coordinating corrective actions and verifying their completion.
Accountable for providing accurate and timely quality control reports to project management, reflecting the true status of quality and compliance on the job.
Qualifications:
Bachelor's degree in construction management, Engineering, or a related field
Proven experience in quality control management within the construction industry
Certified Quality Control Manager through ABC, AGC, or USACE
Proficiency in Procore as well as a solid understanding of construction processes, materials, and methods.
Strong attention to detail, excellent organizational and communication skills, and the ability to manage multiple tasks and priorities effectively
In-depth knowledge of construction processes, quality control procedures, and relevant industry standards and regulations
Ability to identify issues, implement solutions, and ensure high standards of quality throughout the project lifecycle.
Physical Requirements:
In a normal day, this position requires standing and/or walking. In a normal day, the employee must be able walk the project site and be able to sit and perform writing/documentation assignments. In a normal day, the employee must be able to drive 1-4 hours. The employee must be able to lift/carry up to 10 lbs. maximum; occasionally carry small objects. In this position, employee occasionally (0-33%) must be able to bend at waist, squat the knees, climb (including ladders), reach above shoulders, kneel, crawl, use feet (foot controls), and/or work at heights above 6 feet.
Auto-ApplyQuality Assurance Coordinator
Quality assurance manager job in Philadelphia, PA
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
Job Description
The Laboratory Quality Assurance (QA) Coordinator is responsible for ensuring that DPT's quality system is well-documented, traceable, and compliant. This role focuses specifically on regulatory readiness documentation and inspection support. Role is critical in tracking, organizing, and executing the administrative an procedural backbone of the laboratories' quality program.. This position ensures compliance with federal, state, and local regulations (e.g., CLIA, CAP, ISO, FDA) and drives continuous quality improvement initiatives. The QA Coordinator develops and maintains policies, conducts audits, manages documentation, and trains staff on quality procedures.
Key Responsibilities:
Quality Management System (QMS) Oversight:
Develops, implements, and maintains the laboratory's comprehensive quality management system, including the Quality Manual, policies, and procedures.
Regulatory Compliance:
Monitor and ensure continuous compliance with all applicable accreditation and regulatory standards (e.g., CAP, CLIA, ISO 15189, GxP, FDA).
Audits and Inspections:
Coordinate and participate in internal and external audits/inspections, manage the response to findings, and implement corrective and preventive actions (CAPAs). Assist in preparing audit schedules and checklists. Track corrective actions and verify closures. Organize and maintain documentation needed for audits and inspections. Assist in preparing materials and responses for regulatory and accrediting inspections and client audits.
Documentation and Record Control:
Oversees the documentation control system.. Logs and tracks nonconformances, deviations and incident reports. Ensures completeness and accuracy of quality records.
Change Management Support: Log and monitor change requests. Track approval workflows and implementation timelines. Assist in collecting / reminding of required objective evidence for activity / file closure. Ensure related documentation is complete before closure.
Training and Education:
Develop and conduct training sessions for staff on quality standards, new procedures, and best practices to promote a quality culture. Send reminders for upcoming and overdue training, as applicable.
Event and Risk Management:
Assist in investigation of non-conformances, errors, and incidents; perform root cause analysis; and determine corrective actions to mitigate future risks. Ensure timeliness of all activities to meet regulatory expectations. Develop tools to assist with tracking activities / actions.
Communication and Coordination: Schedule QA Meetings and take meeting minutes. Communicate deadlines, updates and quality-related notifications. Serve as liaison between QA and other departments.
Supplier Qualification Program: Develop schedule to ensure Approved Supplier List (ASL) is kept up-to-date. Ensure qualification / re-qualification documentation is current and filed appropriately. Participate in vendor-related SCAR issuance, receipt of responses and assuring documentation meets DPT's requirements.
Qualifications
Required Qualifications and Skills:
Education:
Bachelor's degree, preferably in a chemical, physical, biological science, or Medical Laboratory Science (MLS/MT) from an accredited institution.
Experience:
Minimum of 5-7 years of experience in a clinical or analytical laboratory environment, with demonstrated experience in quality assurance or quality control.
Knowledge:
Strong knowledge of quality management systems (e.g., ISO, CLIA, CAP) and relevant federal/state regulations.
Skills:
Excellent attention to detail and strong organizational skills.
Strong analytical and problem-solving abilities, with an aptitude for data interpretation and statistical analysis.
Excellent written and verbal communication skills, with the ability to effectively communicate with diverse staff and management.
Proficiency with laboratory information management systems (LIMS) and Microsoft Office Suite.
Ability to work both independently and collaboratively in a fast-paced environment.
Preferred Qualifications:
Certification in quality management (e.g., Certified Quality Auditor (CQA) or Six Sigma certification).
Experience with specific laboratory certifications/standards relevant to the lab's specialty (e.g., ASHI, CAP, CLIA,)
Additional Information
Schedule:
Monday - Friday 8:00am-4:30pm
What we offer:
Excellent full time benefits including comprehensive medical coverage, dental, and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays
Eurofins USA Clinical Diagnostics is a Disabled and Veteran Equal Employment Opportunity employer.
Quality Assurance Coordinator
Quality assurance manager job in Philadelphia, PA
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
Job Description
The Laboratory Quality Assurance (QA) Coordinator is responsible for ensuring that DPT's quality system is well-documented, traceable, and compliant. This role focuses specifically on regulatory readiness documentation and inspection support. Role is critical in tracking, organizing, and executing the administrative an procedural backbone of the laboratories' quality program.. This position ensures compliance with federal, state, and local regulations (e.g., CLIA, CAP, ISO, FDA) and drives continuous quality improvement initiatives. The QA Coordinator develops and maintains policies, conducts audits, manages documentation, and trains staff on quality procedures.
Key Responsibilities:
Quality Management System (QMS) Oversight: Develops, implements, and maintains the laboratory's comprehensive quality management system, including the Quality Manual, policies, and procedures.
Regulatory Compliance: Monitor and ensure continuous compliance with all applicable accreditation and regulatory standards (e.g., CAP, CLIA, ISO 15189, GxP, FDA).
Audits and Inspections: Coordinate and participate in internal and external audits/inspections, manage the response to findings, and implement corrective and preventive actions (CAPAs). Assist in preparing audit schedules and checklists. Track corrective actions and verify closures. Organize and maintain documentation needed for audits and inspections. Assist in preparing materials and responses for regulatory and accrediting inspections and client audits.
Documentation and Record Control: Oversees the documentation control system.. Logs and tracks nonconformances, deviations and incident reports. Ensures completeness and accuracy of quality records.
Change Management Support: Log and monitor change requests. Track approval workflows and implementation timelines. Assist in collecting / reminding of required objective evidence for activity / file closure. Ensure related documentation is complete before closure.
Training and Education: Develop and conduct training sessions for staff on quality standards, new procedures, and best practices to promote a quality culture. Send reminders for upcoming and overdue training, as applicable.
Event and Risk Management: Assist in investigation of non-conformances, errors, and incidents; perform root cause analysis; and determine corrective actions to mitigate future risks. Ensure timeliness of all activities to meet regulatory expectations. Develop tools to assist with tracking activities / actions.
Communication and Coordination: Schedule QA Meetings and take meeting minutes. Communicate deadlines, updates and quality-related notifications. Serve as liaison between QA and other departments.
Supplier Qualification Program: Develop schedule to ensure Approved Supplier List (ASL) is kept up-to-date. Ensure qualification / re-qualification documentation is current and filed appropriately. Participate in vendor-related SCAR issuance, receipt of responses and assuring documentation meets DPT's requirements.
Qualifications
Required Qualifications and Skills:
Education: Bachelor's degree, preferably in a chemical, physical, biological science, or Medical Laboratory Science (MLS/MT) from an accredited institution.
Experience: Minimum of 5-7 years of experience in a clinical or analytical laboratory environment, with demonstrated experience in quality assurance or quality control.
Knowledge: Strong knowledge of quality management systems (e.g., ISO, CLIA, CAP) and relevant federal/state regulations.
Skills:
Excellent attention to detail and strong organizational skills.
Strong analytical and problem-solving abilities, with an aptitude for data interpretation and statistical analysis.
Excellent written and verbal communication skills, with the ability to effectively communicate with diverse staff and management.
Proficiency with laboratory information management systems (LIMS) and Microsoft Office Suite.
Ability to work both independently and collaboratively in a fast-paced environment.
Preferred Qualifications:
Certification in quality management (e.g., Certified Quality Auditor (CQA) or Six Sigma certification).
Experience with specific laboratory certifications/standards relevant to the lab's specialty (e.g., ASHI, CAP, CLIA,)
Additional Information
Schedule:
Monday - Friday 8:00am-4:30pm
What we offer:
Excellent full time benefits including comprehensive medical coverage, dental, and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays
Eurofins USA Clinical Diagnostics is a Disabled and Veteran Equal Employment Opportunity employer.
Internal Process Audit/Quality Control Manager
Quality assurance manager job in Chesterbrook, PA
Remote / Hybrid Schedule Job Opportunity from Chesterbrook, PA Seeking an Internal Process Audit / Quality Control Manager with 2-5 years of experience to oversee and enhance the integrity of lending operations. This role reports to senior management and ensures compliance with internal policies and regulatory standards. The role will also manage an offshore team (currently one person).
Responsibilities
* Audit & Quality Control
* Develop and execute internal audit plans for lending processes, focusing on risk, compliance, and operational controls.
* Review loan files, underwriting and documentation processes, ensuring adherence to policy and regulatory requirements.
* Process Improvement
* Analyze audit findings and collaborate with stakeholders to drive remediation and enhancements.
* Monitor KPIs to identify trends, root causes, and implement preventive measures.
* Reporting & Communication
* Create clear and timely audit reports for leadership, highlighting risks and improvement actions.
* Follow up on action plans to verify implementation of recommendations.
* Compliance & Risk Management
* Support external audits and compliance examinations.
* Training & Collaboration
* Train lending teams on quality control best practices.
* Liaise with compliance, legal, underwriting, and ops teams to drive continuous improvements.
Qualifications
Qualifications & Skills:
* Experience
* 2-5 years in internal audit, quality control, or process audit within a lending or financial services environment (more experience is welcome to apply).
* Skills & Knowledge
* Strong understanding of lending lifecycle and regulatory requirements.
* Proficiency in audit methodology, risk assessment, and remedial framework.
* Analytical mindset with attention to detail.
* Education & Certifications
* Bachelor's degree or equivalent experience
* Proficient and PowerPoint and Excel
* Preferred: CIA, CPA, CISA, or certification in lending quality control.
* Soft Skills
* Excellent communication and presentation skills.
* Effective in collaboration and stakeholder management.
The skills mentioned above only describe the essential job functions and are not intended to be a complete list of all duties and responsibilities. All job functions must be performed in accordance with The J.G. Wentworth Company policies and procedures.
Benefits:
* Full Medical/Vision/Dental Benefits
* 401K with Company Match
* Flexible Hybrid or Remote Schedule
* 15 Days PTO
* Paid Holidays
* An Unmatched Company Culture
* On-Site Gym & Gym Membership Reimbursement
* Monthly, Quarterly and Annual Bonuses
* Employee Referral Bonuses
* Public Transportation Discounts
* Company Happy Hours
* Business Casual Dress Code
Start building your career with J.G. Wentworth today!
J.G. Wentworth is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. J.G. Wentworth makes hiring decisions based solely on qualifications, merit, and business needs at the time.
Qualifications & Skills:
* Experience
* 2-5 years in internal audit, quality control, or process audit within a lending or financial services environment (more experience is welcome to apply).
* Skills & Knowledge
* Strong understanding of lending lifecycle and regulatory requirements.
* Proficiency in audit methodology, risk assessment, and remedial framework.
* Analytical mindset with attention to detail.
* Education & Certifications
* Bachelor's degree or equivalent experience
* Proficient and PowerPoint and Excel
* Preferred: CIA, CPA, CISA, or certification in lending quality control.
* Soft Skills
* Excellent communication and presentation skills.
* Effective in collaboration and stakeholder management.
The skills mentioned above only describe the essential job functions and are not intended to be a complete list of all duties and responsibilities. All job functions must be performed in accordance with The J.G. Wentworth Company policies and procedures.
Benefits:
* Full Medical/Vision/Dental Benefits
* 401K with Company Match
* Flexible Hybrid or Remote Schedule
* 15 Days PTO
* Paid Holidays
* An Unmatched Company Culture
* On-Site Gym & Gym Membership Reimbursement
* Monthly, Quarterly and Annual Bonuses
* Employee Referral Bonuses
* Public Transportation Discounts
* Company Happy Hours
* Business Casual Dress Code
Start building your career with J.G. Wentworth today!
J.G. Wentworth is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. J.G. Wentworth makes hiring decisions based solely on qualifications, merit, and business needs at the time.
* Audit & Quality Control
* Develop and execute internal audit plans for lending processes, focusing on risk, compliance, and operational controls.
* Review loan files, underwriting and documentation processes, ensuring adherence to policy and regulatory requirements.
* Process Improvement
* Analyze audit findings and collaborate with stakeholders to drive remediation and enhancements.
* Monitor KPIs to identify trends, root causes, and implement preventive measures.
* Reporting & Communication
* Create clear and timely audit reports for leadership, highlighting risks and improvement actions.
* Follow up on action plans to verify implementation of recommendations.
* Compliance & Risk Management
* Support external audits and compliance examinations.
* Training & Collaboration
* Train lending teams on quality control best practices.
* Liaise with compliance, legal, underwriting, and ops teams to drive continuous improvements.
Auto-ApplyQuality Assurance Coordinator II (Clinical Research)
Quality assurance manager job in Marlton, NJ
About Us:
Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.
Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.
Job Summary:
Ensure that highest standards of data quality and study participant safety are maintained, as well as adherence to study protocols, CenExel SOPs, Site Working Practices (WPs), ICH GCP, Code of Federal Regulations, and IRB Guidelines.
Compensation: $27.15 - $35.50/h depending on education, experience, and skillset.
Essential Responsibilities and Duties:
Assists the QA Manager in the development, implementation and follow-up of quality assurance programs including necessary or appropriate policies and guidelines
Reviews follow-up monitoring visit reports, protocol deviation logs, and quality findings trackers for trend analysis.
Performs ongoing review of a percentage sampling of study inclusion/exclusion, study procedure records, and laboratory reports to ensure that they are conducted according to the protocol, applicable SOPs, ICH/GCP guidelines and federal regulations.
Performs quality review of initially created source documentation, including amendments, to ensure all protocol required procedures are present.
Provides training and education on SOPs, GCP, and federal regulations as appropriate.
Prepares for internal and external audits and FDA inspections.
Attends staff meetings.
Attends site initiation visits, as needed.
Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies.
Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.
Education/Experience/Skills:
Must be able to effectively communicate verbally and in writing.
Must have proper experience and demonstrate mastery of Quality Assurance Coordinator I position.
Minimum 2 years quality assurance experience.
Knowledge/Skills/Abilities: Must be self-directed and able to work with minimal supervision; Must have in depth knowledge of FDA regulations. GCP, and ICH guidelines; Able to take a flexible approach to shifting priorities; Able to manage multiple projects and responsibilities; Motivated to work consistently in a fast paced and rapidly changing environment; Must be detail oriented and have exceptional computer, organizational, and communication skills - both written and oral.
Must reflect the professional image of the company, upholding the company vision in actions, demeanor, and appearance.
Must be able to clearly communicate through written and verbal means with sponsors and staff.
Working Conditions
Indoor, Office environment.
Essential physical requirements include sitting, typing, standing, walking.
Lightly active position, occasional lifting of up to 20 pounds.
Reporting to work, as scheduled, is essential.
On site work arrangement.
CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.
Quality Assurance Coordinator
Quality assurance manager job in Warminster, PA
Job Details Warminster, PA Full Time 4 Year Degree $55000.00 - $55000.00 Salary/year Up to 50% Description
Join us at Delta Community Supports, Inc. (“Delta”), where every day brings the opportunity to make a difference in the lives of others! As a leading provider of support services for individuals with intellectual and developmental disabilities, we're on a mission to empower and enrich the lives of those we serve. Are you passionate about fostering independence, promoting inclusion, and creating meaningful connections? If so, come be a part of our dynamic team where innovation, compassion, and dedication drive our every endeavor. Embark on a rewarding career journey with Delta Community Supports, Inc., and help us shape a brighter future for all!
Delta Community Supports, Inc. is seeking a Quality Assurance Coordinator to support our Quality Assurance department in upholding Delta's mission of delivering high-quality services to the individuals we serve. The Quality Assurance Coordinator will be responsible for monitoring the operational integrity of our residential and vocational programs. Acting as a key liaison between the local and national offices, this role ensures that all programs operate in full compliance with applicable state regulations, agency policies, and procedural standards. The Coordinator will play a critical role in evaluating program performance, driving continuous improvement, and ensuring consistent implementation of best practices across all service areas.
Requirements:
Proven ability to build collaborative relationships with individuals from diverse cultural, socioeconomic, and educational backgrounds.
Strong commitment to diversity, equity, and inclusion.
Excellent organizational, time management, and multitasking abilities with a capacity to meet deadlines under pressure.
Effective interpersonal skills to support individual growth and team development.
Solid understanding of supervisory and administrative practices.
Strong verbal and written communication skills; proficiency in English and basic arithmetic.
Technologically proficient, including Microsoft Office and the ability to adapt to new tools.
Capable of operating standard office equipment and vehicles, with a valid driver's license and compliance with applicable regulations.
Qualifications
Bachelor's degree from an accredited college or university.
Associates degree or sixty (60) credit hours from an accredited university or college and four (4) years' experience working with persons with intellectual disabilities may be substituted for Bachelor's degree.
Two (2) years' work experience working directly with persons with intellectual disabilities
Two (2) years' work experience using electronic health records and database management.
Valid driver's license in the state of residence with a satisfactory driving record.
Commitment to and knowledge of community-based support for persons with disabilities
Working knowledge of management of an effective Quality assurance program
Ability to present facts and recommendations effectively in oral and written form
Independent judgment is required to plan, prioritize, and organize diversified workload
Knowledge and understanding of local regulatory agency operations
Benefits:
401 (k) Match program, with a generous match of 3%.
Comprehensive healthcare coverage, including medical, dental, and vision insurance plans.
Company-paid life Insurance coverage for full-time employees
Voluntary supplemental Insurance options for additional coverage.
Company paid holidays, sick time, and vacation time.
Employee Assistance Program (EAP) provides eligible employees with confidential counseling, support services, and resources to enhance well-being and maintain work-life balance.
Professional development and internal advancement opportunities.
Please note that participation in the listed benefits is contingent upon eligibility criteria..
Please Visit Our Website to complete an Online Application at ****************
EOE M/F/D/V
Senior Manager, QA Biologics & Combination Products Manufacturing
Quality assurance manager job in Wilmington, DE
Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function) The Senior Manager, Quality Assurance (QA) provides oversight for biological and combination products from clinical development through commercial manufacturing.
This position ensures that manufacturing, packaging, labeling, and testing operations are performed in compliance with GMP requirements, regulatory submissions, and Incyte's Global Quality standards and procedures.
The Senior Manager serves as a key quality partner to internal and external stakeholders, supporting the advancement of Incyte's biologics and combination product portfolio throughout the product lifecycle.
Essential Functions of the Job (Key responsibilities) · Provide QA leadership and oversight for biologics and combination products across both clinical and commercial stages of development and manufacturing.
· Support the execution and integration of Incyte's Quality Management Systems (QMS), ensuring consistent application across product lines and manufacturing sites.
· Serve as the primary QA representative for internal and external partners, providing input on quality and operational decisions.
· Review and approve critical GMP documents such as master batch records, specifications, test procedures, and reports.
· Support process validation and transportation qualification activities.
· Review and disposition executed cell bank, drug substance and drug product batches for biologics and combination products in both clinical and commercial stages.
· Provide oversight of supplier and contract manufacturing organization (CMO) quality performance, including Quality Agreement negotiation, supplier qualification, and ongoing compliance monitoring.
· Lead internal and external cGMP audits to ensure compliance and drive continuous improvement.
· Lead QA management of supplier quality events, including investigations, change controls, CAPAs, and complaints, ensuring timely closure and effective root cause analysis.
· Manage internal Quality Events (deviations, CAPAs, continuous improvement, and change controls) in Veeva QMS and ensure adherence to procedural timelines.
· Identify, escalate, and assist in resolving internal and external quality system issues, driving robust corrective and preventive actions.
· Review and contribute to regulatory submissions (INDs, IMPDs, BLAs) and responses to Health Authority inquiries as needed.
· QA lead for Design History File (DHF) preparation and / or Product Specification File (PSF) as applicable.
· Support Incyte combination product quality system procedures review and approval.
· Monitor and report key Quality System metrics and identify trends or risks that require management attention.
· Oversee controlled document management and distribution to external partners and CMOs.
· Coordinate the collection of APQR/YBPR data and lead the issuance of Incyte Annual Product Quality Reviews for the assigned Commercial products.
Qualifications (Minimal acceptable level of education, work experience, and competency) · Degree (such as Bachelor's, Master's, or Ph.
D.
)in a scientific or engineering discipline (e.
g.
, Pharmacy, Chemistry, Biotechnology, or related field), or equivalent relevant experience.
· Typically requires 5-7 years of relevant experience in the pharmaceutical or biopharmaceutical industry, with at least 5 years in a GMP quality or regulatory function, or the equivalent combination of education, training, and experience.
· Proven experience in managing GMP operations and quality oversight for biological and combination products throughout clinical development and commercial manufacturing.
· Sound awareness and understanding of the pharmaceutical business, especially with regards to quality and international regulatory requirements (including but not limited to US, EU, CH, MHRA, CA, JP).
· Demonstrated leadership in managing CMO/partner quality relationships, including audits, investigations, and performance governance.
· Strong problem-solving skills with the ability to make sound quality and compliance decisions.
· Excellent organizational, project management, and interpersonal skills, with the ability to lead cross-functional quality initiatives, fostering an inclusive environment.
· Strong written and verbal communication skills, including experience collaborating with Health Authorities and senior management.
· Ability to travel 15-20% or more as required, both domestic and international, with reasonable accommodation made for qualified individuals with disabilities.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job.
They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.
Management reserves the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy Learn more at: ***********
incyte.
com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job.
You can learn more about this process here.
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data.
You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte's data protection practices here.
By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).
Please contact privacy@incyte.
com if you have any questions or concerns or would like to exercise your rights.