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Director Of Quality Assurance And Regulatory Affairs Jobs

Vp Quality And Regulatory Affairs
By Proven Recruiting At San Diego, CA, United States
Management review of quality and regulatory team.
Manage the preparation and development of regulatory submission packages.
Oversee document control, internal and external audits, complaint system, CAPA, NCMRs, and key supplier qualifications.
Prior experience authoring and filing of regulatory documents.
Responsible for regulatory submission strategies to support product development and approval of various medical device products.
Interface with regulatory authorities and internal technical teams on regulatory submissions.
Director, Us Medical Affairs, Patient Access, And Quality Of Care (Paq) – Oncology Solid Tumor Strategy
By Gilead Sciences At , Foster City
Effective organizational, project planning, and time management skills. Strong sense of urgency and goal orientation
Assist with management of PAQ Medical Affairs Advisory Programs (MAAPs)
Extensive knowledge of the US healthcare ecosystems, payer landscape and payer evidence requirements
Excellent strategic thinking skills, with demonstrated ability to successfully lead the ideation, development of a plan and move to action
Solid working knowledge of regulatory and compliance environment
Professional written and verbal communication skills with the ability to effectively present to and engage with a wide range of audiences
Director Of Quality And Regulatory Affairs; Full Time; Days
By Mount Sinai At , New York, 10029 $140,000 - $230,584 a year
Responsible for supporting the management of an operating budget for the department.
Maintains current knowledge of quality improvement information, patient safety, and regulatory requirements.
Coordinates all documentation requirements for the Performance Improvement and National Patient Safety Goal chapters of The Joint Commission manual.
Supports the coordination and direction all activities to ensure the effective implementation of the Quality Improvement Plan.
Designs, develops, implements and evaluates quality improvement policies and procedures.
Develops and facilitates the use of data collection tools to support data analysis.
Director Of Regulatory & Quality/ 监管与质量保证总监
By Medical Instrument Development Laboratories At , San Leandro, 94577 $160,000 - $180,000 a year

Position Title: Director of Regulatory Affairs and Quality Assurance

Director Of Quality And Regulatory Compliance Rn
By KA Recruiting, Inc. At Lewisburg, WV, United States

DIRECTOR OF QUALITY & REGULATORY COMPLIANCE NEEDED IN WEST VIRGINIA full time, permanent position extremely competitive pay excellent benefits bachelor"s required registered nurse certification ...

Senior Director Of Quality And Regulatory Affairs
By Goodall Brazier At Texas, United States
12+ years related GMP experience in biotechnology, chemistry, biochemistry, microbiology, pharmaceutical, manufacturing, or laboratory environment. 7-10 years experience in Quality Management.
Expert knowledge of GMP, FDA, and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products
Regulatory Knowledge CBER, CDER, CDRH, and other global agencies
Experience interacting with FDA and other global agencies
Ability to prepare audit reports, quality agreements, standard operating procedures, and CAPA reports in accordance with companies Quality System requirements
Experience leading a Quality Dept at a CDMO (preferred)
Director/Senior Director – Quality Engineering And Regulatory
By PBS Biotech At Camarillo, CA, United States
Accountable for management and maintenance of program for sterilization qualification, shipping/transport studies, packaging, and shelf life.
Accountable for maturation of existing quality systems for risk management and validation.
Program-level experience with validation or equivalent verification/validation, or qualification
Skills/ Abilities Pertinent To This Position
Experience leading and mentoring staff and colleagues
Able to perform analysis to support material selection and qualification of pharmaceutical-grade materials
Lead Specialist-Quality And Regulatory Assurance
By World Courier At Salt Lake City Metropolitan Area, United States
MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:
Monitors the overall compliance program at the operating level and works closely with the CSRA Manager.
Tracks and maintains records as per regulatory requirements.
Participates in the investigation of compliance-related incidents, under the direction of the CSRA Manager or CSRA Director.
In the CSRA Manager’s absence, operates as liaison for the DC with Federal, State and local regulatory agencies.
Knowledge of legal and regulatory compliance regulations
Director Of Quality Affairs, Intuitive Fluorescence Imaging
By Intuitive Surgical At , Sunnyvale, Ca $170,000 - $300,000 a year
7 years of direct Quality Assurance management experience in regulated industry (pharma/biotech and medical device)
Assist with establishing metrics and reporting the state of GCP Quality and compliance of clinical trials to senior management.
GMP Manufacturing Quality oversight of process and method validations, change controls, investigations, and Supplier Qualification.
Responsible to coordinate with International Quality team members to support further regional product release and regulatory filing/distribution requirements.
Actively work with cross-functional groups and CMOs to manage receipt, review, approval, and storage of documents provided by CMOs.
Support continued risk-based supplier qualification program and creation or review of related Quality Technical Agreements (QTA).
Vice President, Head Of Regulatory Affairs And Quality Assurance
By Scorpion Therapeutics At , Boston, 02114, Ma
Ensure the qualification, selection and management of vendors and contractors through a defined qualified process
Design and maintain a fit-for-purpose quality management system (QMS) across the GxPs
Develop and manage Global Regulatory Affairs and QA budgets
Extensive experience leading, designing, writing and submission of regulatory filings and correspondence
Excellent written and oral communication skills and the ability to effectively communicate with internal and external team members on project activities
Strong problem solving, critical thinking and analytical skills, required to make sound decisions
Director Of Quality Management And Regulatory Compliance
By Northwest Medical Center Tucson At , Tucson, Az
Director of Quality Management and Regulatory Compliance
Location TUCSON, AZ (Northwest Medical Center Tucson)Full Time
Location TUCSON, AZ (Northwest Medical Center Tucson)
Co-Op, Regulatory And Quality Affairs
By Alexion Pharmaceuticals,Inc. At , Boston, Ma
Organized individual with the ability to manage multiple priorities while maintaining high performance standards
Becoming familiar with laws, guidances, and regulatory requirements for drugs and combination products
Excellent written, verbal, and presentation skills and strong interpersonal skills
Working with regulatory subteams to support development and execution of regulatory strategies for compounds in development and/or for marketed products
Supporting submissions to relevant health authories across the globe
Researching and interpreting guidances and resources issued by health authorities and providing information to project teams to aid in strategic decisions
Director, Global Quality Customer Affairs
By Alcon At , Fort Worth, Tx $169,280 - $253,920 a year
Management of Optometry/Ophthalmology network (extensive experience communicating with O.D./M.D.)
5 years of experience in a surgical ophthalmic clinical setting (cataract, refractive, retina)
Bachelor’s Degree or Equivalent years of directly related experience (or high school +18 yrs; Assoc.+14 yrs; M.S.+7 yrs; PhD+6 yrs)
10 Years of Relevant Experience
Ensures services, processes, and facilities are in compliance with the organization’s Quality Assurance (QA) standards, international standards, and government regulations.
Establishes quantitative measurements and techniques for measuring quality and drives improvements.
Vice President Of Quality And Regulatory Affairs
By Staffing Resource Group, Inc At Cranbury, NJ, United States
OTHER SKILLS, ABILITIES OR QUALIFICATIONS
Project Management, Change Execution Management and Team Leadership experience in a Quality function a plus.
·Management of QA, QC, and Compliance team
·Demonstrated supervisory experience, leadership, and teamwork skills.
Ability to work independently as well as manage teams.
Strong quality mind and technical knowledge.
Director/ Senior Director, Quality Assurance And Regulatory Affairs
By Ginkgo Bioworks At , Remote $175,000 a year
Manage quality systems, and inform senior leadership in compliance with quality system requirements
Participate with leadership in setting strategic direction and developing the capabilities of the QA/RA team
Bachelor's degree and 10+ years of related experience
Strong knowledge of quality and regulatory standards pertaining to surveillance testing, approved diagnostics, and sample collection kits
High level of knowledge of business operations, objectives and strategies
Excellent problem-solving and decision-making skills
Associate Director, Quality Assurance & Regulatory Affairs
By Charles River Laboratories At , Northridge, 91325, Ca $137,900 - $186,500 a year
A minimum of 3 years supervisory or management experience required.
Coordinate and Manage Supplier Qualification and Vendor Qualification processes. Maintain all applicable documentation and records.
Process Improvement activities including developing statistical reports for tracking and trending quality system reports for reporting to executive management.
Working knowledge of federal and state requirements for human subject research protection, peripheral stem cell collections, and blood donor centers.
Support regulatory inspections and Supplier Qualification Audits, coordinate responses, maintain all applicable documentation and records.
Monitor all applicable government and accreditation agency regulations and requirements to ensure compliance. Notify operations of regulatory changes.
Director Of Quality Assurance
By Kirkland and Ellis At , Houston, 77002, Tx
3 years of experience in management of QA organization including management of third parties that are also delivering QA services.
Ensure that management and allocation of QA resources based on project needs is performed.
Bachelor's degree in Computer Science, Computer Engineering, Information Technology or equivalent experience.
10 years of experience in software development and software quality assurance.
3 years of experience working in Agile development process.
3 years of experience with performance and load testing.
Director Of Quality Assurance
By Kirkland and Ellis At , Miami, 33131, Fl
3 years of experience in management of QA organization including management of third parties that are also delivering QA services.
Ensure that management and allocation of QA resources based on project needs is performed.
Bachelor's degree in Computer Science, Computer Engineering, Information Technology or equivalent experience.
10 years of experience in software development and software quality assurance.
3 years of experience working in Agile development process.
3 years of experience with performance and load testing.