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Clinical Quality Assurance Consultant Jobs

Clinical Quality Assurance Specialist
By OpenLoop At United States
4-7 years of Quality Assurance experience required
Advanced computer skills a must
Excellent organization and documentation skills required
Responsibilities include, but are not limited to:
Evaluate, track, and monitor clinical operations activities and standards internally and client facing
Improve existing and develop new clinical regulatory quality standards and procedures
Clinical Quality Assurance Reviewers (Behavioral Health)
By Directions for Living At Clearwater, FL, United States

Do you envision working for a dynamic, mission-driven organization which supports the community while fostering an employee culture of appreciation and fun? If your answer is yes, then an employment ...

Associate Director, Clinical Quality Assurance (Remote)
By EISEISUS At , Woodcliff Lake, 07677
Preferably 8+ years’ experience in Clinical research/ operations/data management or related area. Minimum of 3-6 years of Clinical Quality Assurance auditing
Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently
Author and manage Audit Plans and Audit reports
Manage health authority inspection preparation activities and provide leadership and oversight during inspections
Manage direct reports (if applicable)
Technical and administrative capabilities to independently carry out routine, complex and for-cause audits
Clinical Quality Assurance Manager- Pharmaceutical
By Teva Pharmaceuticals At , West Chester, 19380
Excellent change management skills, with the ability to assess readiness and implement appropriate opportunities for change.
Develop and deliver training programs on quality assurance topics to enhance staff knowledge and compliance awareness.
Stay abreast of regulatory requirements, industry best practices, and emerging trends in clinical quality assurance.
Minimum of 3-5 years of experience in the pharmaceutical industry, with a strong understanding of GxP regulations and practices.
Proficiency in Good Clinical Practice (GCP) guidelines and experience with regulatory inspections (FDA, MHRA, EMA, etc.).
Demonstrates a customer-focused approach and possesses excellent interpersonal, communication, and facilitation skills.
Clinical Quality Assurance Professional
By Signature Group Recruitment At United States
Support the Clinical vendor qualification, selection, and management process
Working knowledge of inspection management
Demonstrated project management and leadership skills
Minimum of 3 years experience in the Biotech, Medical Device, Pharmaceutical or Healthcare industries
Minimum of 2 years experience in clinical and/or quality system compliance and auditing
Knowledge of Good Clinical Practices (GCP) and all applicable regulations
Associate Director, Clinical Quality Assurance (Remote)
By Merck Sharp & Dohme At , West Point, 19486 $118,640 - $186,800 a year
Provide inspection management support as appropriate.
Design and actively participate in special assignments on various project teams and work streams as determined by QA management.
Provides training and mentorship to less experienced members of QA staff.
BS/BA degree in a relevant area with 8+ years of experience in the pharmaceutical industry.
GCP QA site audit experience.
Interfaces with relevant stakeholders, including regulatory, clinical and development sub-teams, as appropriate to provide Good Clinical Practice, Pharmacovigilance and QA expertise.
Associate Director, Clinical Quality Assurance (Remote)
By MSD At , West Point $118,640 - $186,800 a year
Provide inspection management support as appropriate.
Design and actively participate in special assignments on various project teams and work streams as determined by QA management.
Provides training and mentorship to less experienced members of QA staff.
BS/BA degree in a relevant area with 8+ years of experience in the pharmaceutical industry.
GCP QA site audit experience.
Interfaces with relevant stakeholders, including regulatory, clinical and development sub-teams, as appropriate to provide Good Clinical Practice, Pharmacovigilance and QA expertise.
Assoc Gmp Quality Assurance Director - Clinical
By Exelixis, Inc. At , Alameda, 94502 $146,000 - $207,500 a year
Equivalent combination of education and experience.
Manages QA review of manufacturing records, clinical trial documentation and documents submitted to regulatory agencies.
Oversees and manages the GMP auditing process, and all other relevant QA inspectional activities.
BS/BA degree in related discipline and a minimum of 11 years of related QA experience; or,
MS/MA degree in related discipline and a minimum of 9 years of related QA experience; or,
PhD in related discipline and a minimum of 5 years of related QA experience; or
Program Manager, Clinical Quality Assurance
By Takeda Pharmaceutical At , Boston, Ma
Solid judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines
Analyze, report, and present metrics for assigned programs to development teams and CQA management; recommend any required actions and monitor implementation.
Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution
Perform additional GCP related activities upon request by CQA management
Minimum of 5 years of experience in the pharmaceutical, biotechnology or related health care industry.
Minimum 2 years of GCP-related Quality Assurance or relevant clinical trial experience.
Clinical Quality Assurance Professional - Remote
By W. L. Gore & Associates At , Flagstaff, 86001, Az
Support the Clinical vendor qualification, selection, and management process
Working knowledge of inspection management
Demonstrated project management and leadership skills
Minimum of 3 years experience in the Biotech, Medical Device, Pharmaceutical or Healthcare industries
Minimum of 2 years experience in clinical and/or quality system compliance and auditing
Knowledge of Good Clinical Practices (GCP) and all applicable regulations
Director, Clinical Quality Assurance
By Arcus Biosciences At , Remote
Expert knowledge of global GCP requirements and applicable drug development regulations, including USA (FDA), EU (EMA, MHRA), and ICH Guidelines.
Experience leading audits of GCP vendors and investigator sites.
A strong team player with great interpersonal and written communication skills
Support clinical study teams for assigned studies through attendance at study meetings, review of study documents, and consultation on GCP-related questions.
Identify and escalate significant compliance issues to Clinical QA and other relevant leadership, including the assessment of serious breaches.
Maintain high level of expertise in global GCP regulations and internal policies and procedures that impact clinical study conduct.
Quality Assurance Operations Consultant
By Life Science People At United States
Manage material disposition for commercial and clinical trial materials.
Manage the review of product release and stability data.
Possess a scientific degree (BS) and have at least 5-8+ years of experience in the pharmaceutical/biotech industry.
5+ years of experience in Quality Assurance.
Preferred experience with topical and liquid dosage forms.
Provide quality oversight for contract manufacturing operations of drug substance and drug product, both for commercial and clinical trial materials.
Quality Assurance - Clinical Research
By ViTalent At Westfield, IN, United States
Proven track record of strong project management skills and experience managing clinical trial delivery activities for drug development programs.
Solid knowledge of drug development, clinical trial management and/or GCP compliance processes
Education, Experience, Competencies And Skills
Solid knowledge of regulatory requirements governing clinical trial, industry best practices and related standard and documentation requirements
Must be able to efficiently utilize computer software programs such as Microsoft Office for general use, project management and presentations
Ensure compliance with Sponsor Learning Curricula, corporate and/or GXP requirements.
Clinical Quality Program Consultant
By Elevance Health At Honolulu, HI, United States
Current unrestricted license or certification in applicable field preferred (i.e., CPHQ).
National +50 Miles away from nearest PulsePoint, National +50 Miles away from nearest PulsePoint
Co-leads state level quality strategy meetings, develops a quality plan, and ensures integration of quality into the overall business process.
Works with the clinical intervention team to design studies to identify barriers to medical interventions.
Ensures that study methodology is sound and appropriate reporting is in place.
Develops performance improvement plans and oversees the clinical quality improvement activities to improve the quality of care for members.
Quality Assurance Consultant Jobs
By Verbatim Pharma At United States
Verbatim Pharma are currently working with a global pharmaceutical company who are looking for a Quality Manager.
I am looking for someone with experience in -
Interim Quality Assurance Consultant Position
Host internal and external audits
Working in a GMP/GDP environment
Some of the key responsibility's for this position are -
Senior Manager, Clinical Quality Assurance
By CRISPR Therapeutics At Boston, MA, United States
Demonstrated knowledge and/or prior experience in Quality Assurance
Ability to manage multiple studies/projects and to collaborate effectively in a dynamic, cross-functional matrix environment
BS/BA with 8 to 10 years of experience in pharmaceutical / biotech industry with experience in the GLP/GCLP environment
Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for GLP/GCLP
Practical knowledge of GLP/GCLP related audits activities and business standards
Prior experience with nonclinical studies and CRO oversight
Senior Quality Assurance Consultant
By Elegant Enterprise-Wide Solutions, Inc. At United States
G. Three years of experience with Application Lifecycle Management, tracking bug fixes, test results, and release management.
*Candidates chosen for an interview will meet the Education, General Experience and Specialized Experience requirements.
A. Two years of experience with establishing and executing automated test procedures.
B. Three years of software testing experience (integration and acceptance) on multiple projects.
D. Three years of experience testing database interfaces in a multi release project environment.
A. Determine the resources required for quality control.
Associate Director/Sr Manager Clinical Quality Assurance
By Meet At Pennsylvania, United States
Management of external vendors (CROs and CTLs)
Experience and ability to manage and start a QA department from scratch
Clinical Quality Senior Manager/Associate Director – Competitive Salary + Great Benefits + Hybrid
Proceeding to the Qualification and Validation of external vendors
To be successful in this role, your experience will need to include:
Conducting External and Internal GCP audits (US)
National Director Of Quality Assurance / Clinical
By HRA Senior Living At , Orlando, 32819, Fl
Applies technical skill and abilities for program design, development, implementation and evaluation
Utilizes management expertise to assist communities with resident care and nursing personnel issues
Collaborates with the senior management team members to achieve and maintain company goals
Experience using Microsoft Office and Outlook software. Basic typing skills required
Able to communicate effectively with all levels of management, associates, residents, family members, state regulatory agencies, hospitals, and outside contacts
Responsible to maintain current knowledge of state and local regulations
Clinical (Gcp) Quality Assurance Specialist
By a pharmaceutical company located in the Menlo Park, CA area At Menlo Park, CA, United States
Maintain a contemporary knowledge of current agency and industry trends, standards, and methodologies as related to GCPs.
Minimum 5+ years’ experience in clinical stage pharmaceutical companies
Experience developing GCP processes for the best industry practices and training personnel
Participating in review and approval of clinical study documents and clinical SOPs / Guidance Documents
Managing study specific Clinical Study Audit Plans (CSAP) compliance for assigned program by using risk-based approach for the company’s clinical studies
Reviewing and approving investigational product (IP) temperature excursions to ensure release or rejection of IP in a timely manner

Are you looking for an exciting opportunity to make a difference in the healthcare industry? We are looking for a Clinical Quality Assurance Consultant to join our team and help ensure the highest quality of care for our patients. As a Clinical Quality Assurance Consultant, you will be responsible for developing and implementing quality assurance processes and procedures, monitoring compliance with regulatory requirements, and providing feedback and recommendations for improvement. If you are a highly motivated individual with a passion for quality assurance, then this is the perfect job for you!

Overview:

A Clinical Quality Assurance Consultant is responsible for ensuring the quality of clinical services provided by healthcare organizations. They are responsible for developing and implementing quality assurance programs, conducting audits, and providing feedback to healthcare organizations on their performance.

Detailed Job Description:

Clinical Quality Assurance Consultants are responsible for developing and implementing quality assurance programs to ensure the quality of clinical services provided by healthcare organizations. They are responsible for conducting audits of healthcare organizations to evaluate their performance and compliance with regulations and standards. They also provide feedback to healthcare organizations on their performance and suggest areas for improvement. In addition, they may also provide training and education to healthcare staff on quality assurance topics.

What is Clinical Quality Assurance Consultant Job Skills Required?

• Knowledge of healthcare regulations and standards
• Excellent communication and interpersonal skills
• Analytical and problem-solving skills
• Attention to detail
• Ability to work independently
• Ability to work in a team environment

What is Clinical Quality Assurance Consultant Job Qualifications?

• Bachelor’s degree in healthcare administration, public health, or a related field
• Certification in quality assurance or related field
• Previous experience in quality assurance or related field

What is Clinical Quality Assurance Consultant Job Knowledge?

• Knowledge of healthcare regulations and standards
• Knowledge of quality assurance principles and practices
• Knowledge of data analysis and reporting techniques

What is Clinical Quality Assurance Consultant Job Experience?

• Previous experience in quality assurance or related field
• Experience conducting audits and providing feedback
• Experience developing and implementing quality assurance programs

What is Clinical Quality Assurance Consultant Job Responsibilities?

• Develop and implement quality assurance programs
• Conduct audits of healthcare organizations
• Provide feedback to healthcare organizations on their performance
• Provide training and education to healthcare staff on quality assurance topics
• Monitor compliance with regulations and standards
• Analyze data and generate reports