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
Clinical Quality Director Jobs
By Brightline At United States
Minimum of 3 years of experience in healthcare quality management or a related role.
Strong project management skills required. Ability to organize and execute on on-going projects.
Partner closely with Care Leadership in setting the strategic direction for quality management
Oversee the Quality Management Framework per NCQA standards as it applies with member safety, quality assurance, member complaints, and incident management.
Ability to think strategically about quality management and operationalize that strategy with partners
Strong knowledge and understanding of NCQA requirements
Director, Quality Assurance Jobs
By Symbio Research At United States
We offer a competitive salary and benefits package. Salary will be commensurate with experience and education level.
Excellent organizational and time management skills
Expert knowledge of FDA/ICH GCP requirements with strong knowledge of local and global regulatory, quality related requirements, applying to clinical trials
Experience conducting audits of computer systems, investigative sites, clinical study databases
Effective communication skills required to ensure compliance issues are clear to all stakeholders
Bachelor's degree in a science related field
Director Of Quality Assurance - Pharma
By Umbrex At United States
Strong Attention to detail, effective time management and strong organizational skills
Experienced in quality assurance policies, procedures, and audits
**This is a 1099 contract role with no health insurance benefits**
Utilize Strong technical writing ability for SOPs, Protocols, Deviations, and other quality related documents
Build, monitor and report on the compliance status of QMS system
Ensure control of systems, processes and product through review and approval of change control and risk-based implementation.
Director Of Quality Assurance
By CW1 At United States
Strong knowledge of quality management systems, methodologies, and regulatory requirements (e.g., ISO 9001, FDA, etc.)
Establish and maintain robust quality management systems and processes to ensure compliance with regulatory requirements and industry standards
Bachelor's degree in engineering, quality management, or a related field; master's degree or relevant certifications preferred
Excellent leadership and people management skills with the ability to motivate and develop high-performing teams
Strong project management skills with the ability to prioritize and manage multiple initiatives simultaneously
Lead and manage a team of quality professionals, providing mentorship, training, and guidance to foster a culture of quality excellence
Associate Director, Clinical Quality Assurance (Remote)
By Takeda At United States
Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines
Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution
Participate in due diligence activities and process improvement initiatives, as requested by management
Mentor and provide support to Manager level CQA personnel, as needed
Minimum of 10 years of experience in the pharmaceutical, biotechnology or related health care industry.
Minimum 7 years of GCP-related Quality Assurance or relevant clinical trial and medical device experience.
Director Of Quality Assurance
By Oliver Carol Recruitment At Greater Fayetteville, AR Area, United States

Title : Director of Quality and Food Safety Salary : $135,000-$140,000 + Benefits inc. Medical Insurance, Dental, Vision. Category : Fast Paced CPG Manufacturing Location : North-West Arkansas ...

Director Of Quality Assurance
By TriVista Recruitment At Winston-Salem, NC, United States
Experience with quality management systems (SQF, ISO, HACCP, GMP, etc.).
Embrace the opportunity to be a valued member of the management team and grow professionally as the company grows.
Contribute significantly to company goals through the support of a small, highly competent management team.
Bachelor's or Master's degree in Food Science, Food Technology, Microbiology, Quality Management, or related field.
Minimum of ten years of progressive experience in quality assurance and quality control within the food manufacturing industry.
Strong understanding of food safety regulations, standards, and compliance requirements.
Director Of Quality Assurance
By CARsgen Therapeutics At North Carolina, United States
2.2 At least 3 years management experience in a biotech industry
2.7 Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues.
2.9 Strong interpersonal skills, with experience in leading high-performance team and cross functional projects.
1.7 Ensure the validation programs and SOPs are properly established and they meet regulatory requirements.
2.3 Experience in hosting FDA, EMA, and other regulatory agencies’ inspections
2.4 Experience in establishing and improving quality systems.
Director/ Senior Director, Quality Assurance
By Evommune At Palo Alto, CA, United States
Participate in and provide QA direction in development program planning and management meetings.
Responsible for maintaining current knowledge of applicable compliance requirements through attendance at industry and regulatory agency sponsored meetings and seminars.
BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent combination of education and experience
Manage QA consultants and other external vendors, including organizing and prioritizing group tasks, performing training; expand QA department, as needed.
12+ years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices
Strong interpersonal, communication, teamwork, and analytical skills
Director-Quality Assurance Jobs
By MRIGlobal At Kansas City, MO, United States
Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.
Implemented or operated a quality program with an internationally recognized Quality Management System (ISO 9001, ISO 17025, and/or ISO 13485 standards)
Experience in FDA regulated manufacturing preferred.
Evaluates Quality Assurance staff performance accurately and fairly. Communicates and discusses performance on a regular basis. Prepares performance appraisals.
Identifies key development needs for staff and works to mentor staff and provide appropriate training and assignments in core competency areas.
Bachelor’s degree in chemistry, biology, or related field
Director Quality Assurance Jobs
By Life Science People At San Jose, CA, United States
Collaborate with cross-functional teams, including development, product management, and customer support, to drive quality initiatives.
Present regular quality status reports to senior management, highlighting areas of concern and improvement opportunities.
Recruit, mentor, and manage a high-performing QA team, providing coaching and professional development opportunities.
Foster a collaborative and inclusive team environment that encourages open communication and knowledge sharing.
Experience with test automation tools and frameworks.
Excellent communication, leadership, and interpersonal skills.
Director, Quality Assurance (Internal Only)
By Aspirion Health Resources LLC At , Remote $100,000 - $120,000 a year
Highly developed oral and written interpersonal, communication, negotiation and conflict management skills and the ability to work effectively with other people
Establishes quality and reliability standards by partnering with operations leadership, other members of management, and with production operators and analysts
Evaluates program operations from a strategic level to ensure that program meets quality, integrity, functionality, and outcome requirements
Calibrates with Learning & Development team to identify and deploy education and training opportunities aligned to identified trends for improvement
Completes quality assurance operational requirements by scheduling and assigning Quality Assurance Specialists workflows and following up on work results
Bachelor's degree, or 3-5 years of progressive leadership experience (required)
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
Director Of Quality Assurance
By Affordable Solar At , Albuquerque, 87109
Bachelor's Degree in engineering, business, or construction management. Relevant work experience is also to be considered as an alternative.
Oversee the preparation and control of project-specific quality system management documentation prior to project commencement.
Manages quality assurance staff job results by coaching, counseling, and disciplining employees.
10+ years of construction QA/QC experience, preferably in solar, civil, or utility infrastructure projects
Assures quality products and processes by establishing and enforcing quality standards and testing procedures for materials and products.
Preparation of QA manual control and supervision of all amendments and revisions.
Director Of Quality Assurance
By Pura At Pleasant Grove, UT, United States
Strong knowledge of quality management principles, methodologies, and frameworks (e.g., Six Sigma, Lean, ISO standards).
Guide the leadership team in the integration and management of a world class QMS for Pura products and processes.
Adept at communicating up. Communication skills coach for junior team members.
Strong problem-solving abilities, root cause analysis, and attention to detail.
Implement ISO 9000 (or equivalent QMS) companywide.
Develop and implement a quality production program to ensure conformity of purchased material and final products to quality standards.
Associate Director / Director, Quality Assurance (Gmp And Gcp)
By Ocugen Inc At , Malvern, 19355
Proven background in GCP and GMP audit management, risk management, mitigation, and controls.
Job title is commensurate with experience and skills.
Develop and manage department budgets and long-range plans for the team
10+ years of relevant and current work experience in pharmaceutical QA/QC required.
Strong knowledge of biologics, gene and/or cell therapy manufacturing processes.
Hire, develop, and retain QA personnel to create a high-performing credible team.
Director, Quality Assurance Jobs
By Vector Laboratories, Inc. At Newark, CA, United States
Ensures adherence to change management process and support validation activities such as development of user requirements, protocols and reports.
Leads Quarterly Management Reviews with the executive team.
Ability to make risk-based and phase appropriate decisions and effectively communicate risks to management.
Leads internal audits, customer audits as well as surveillance and certification audits by our notified body to ensure compliance.
Strong verbal and written communication skills and ability to navigate stakeholders from various departments.
Requires knowledge of ISO 9001 and/or ISO 13485, 21 CFR 820, or ICH Q7.
Director, Gcp Quality Assurance
By Cellectis At , New York
Develop and maintain appropriate TMF management process.
Maintain expert knowledge in regulatory requirements including cGCP principles
Technical Skills Requirements / Core Competencies
Manage and/or deliver yearly cGCP training for staff.
Experience as an Auditor within the GCP area preferred.
Experience in Oncology is preferred.
Director Quality Assurance Jobs
By SEKISUI Diagnostics, LLC At , San Diego, 92121 $185,000 - $215,000 a year
Sekisui Diagnostics offers a competitive compensation.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
To be successful in this role
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.