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Clinical Quality Assurance Director Jobs in San Diego, California

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
Director Of Gcp Quality Assurance
By BioPhase At San Diego, CA, United States
Working knowledge of quality risk management concepts
Internal trend analysis of audit observations; identifies and communicates to QA management all compliance risks
Ensures that the GCP Vendor Audit Schedule is created and approved by management
Experience auditing GCP vendors, internal GCP processes and documents and clinical investigator sites
Extensive knowledge and/or awareness of ICH GCP regulations and guidance for clinical and nonclinical development.
Knowledge of global regulatory standards and associated guidance’s/guidelines
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 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 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.
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
Executive Director, Global Quality Assurance
By BioSpace At Novato, CA, United States
Oversees and leads quality and compliance risk management initiatives to minimize risk and potential impact of quality and/or non-compliance events
Provide leadership in global issue management (GIM) including product complaints and product recall process management and reporting.
Extensive knowledge and experience in GMP, GCP and GDP global regulations, principles, concepts, practices, and standards.
Demonstrated ability to work effectively in a matrix environment and drive results through “influence” as well as direct management
Develop and manage department budgets and long-range plans for the team.
15+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other highly regulated industry
Director Of Quality Assurance
By SciPro At Los Angeles Metropolitan Area, United States
Manage an effective quality assurance program that monitors for and resolves issues before they become problems.
Arrange staff training on a regular and ongoing basis. Ensure project training program meets all corporate requirements.
7+ years relevant professional experience required.
Experience in leading Quality Operations
Oversee the day-to-day functions of the Quality Assurance (QA) department.
Supervise the development and regular update of policies and procedures.
Director Of Quality Assurance/Quality Controls
By Steele's Executive Search At San Francisco, CA, United States
·Experience in cleaning validation, process validation and supply chain management.
C.) Thorough knowledge of 21 CFR 820.
F.)Experience in USFDA and ISO auditing and ability to lead team to successful audits.
G.) Experience with designing and developing test cases based upon system specifications.
· Minimum 5-7 years of experience in leading company to maintain GMP, ISO and FDA Regulations
4.) Directs and enforces GMP’s, GLP’s, and safety policies.
Director Of Quality Assurance
By Sierra Circuits At Sunnyvale, CA, United States
Demonstrated experience and success in staff management and creating a collaborative and positive work environment.
Possess strong time management and organization skills (must be able to multi-tasks).
Initiate and improve company-wide efforts to improve customer service experience.
Manage activities (including vendors/suppliers) to ensure continuous control over materials, facilities, services and products.
8-10 years demonstrated experience in overseeing Quality Assurance/Engineering department for small to mid-sized PCB organization.
Knowledge and understanding of PCB manufacturing technologies.
Director, Device Quality Assurance
By Coherus BioSciences At , Redwood City, 94065, Ca $185,000 - $230,000 a year
Experience in supplier management and relations, including quality agreement generation and maintenance
Thorough of design control principles and risk management (FMEA and Hazard Analyses)
Demonstrate excellent interpersonal communication skills, which enable you work with multiple BD business units.
Ability to communicate ideas and knowledge effectively and clearly to other individuals, teams and customers.
Quality Engineering experience or 12+ years industry experience (Healthcare/ Pharmaceutical)
Good written and oral communication skills
Director Clinical Quality Improvement
By San Ramon Regional Medical Center At , San Ramon, 94583, Ca $79.39 - $127.02 an hour

The individual in this position is a key member of the hospital management team, and provides leadership and oversight to the strategic development and implementation of the quality and patient ...

Director, Quality Assurance Jobs
By Pharmavite LLC At , , Ca $180,300 - $270,600 a year
Strong project management and presentation skills.
Comprehensive knowledge of quality assurance and compliance with Food and Drug Regulations and associated cGMP compliance requirements.
Required Skills and Capabilities you’ll need to have:
Good critical and deductive reasoning, and agile decision-making skills.
Comprehensive knowledge of manufacturing operations, GMP’s, GLP’s, SOPs, auditing, and inspection.
Strong people development and leadership skills
Director Clinical Quality Improvement
By Bestinfo Systems LLC At San Ramon, CA, United States
Job Title: DIRECTOR CLINICAL QUALITY IMPROVEMENT
Job Location: San Ramon, California, United States
Industry: Healthcare / Health Services - Nursing / LPNs / LVNs
Job Category: Medical / Health - Nurse Leadership
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-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 (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, 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.
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.
Director Of Quality Assurance
By Kalix At Minot, ND, United States
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:
Knowledge of industry accreditation and ICF/IID standards as well as state licensure requirements and agency policies and procedures.
Coordinate annual review and update of agency policies and procedures to ensure compliance with all standards for accreditation, certification, and licensure.
Coordination of agency record-keeping systems to ensure compliance with all required accreditation, licensure, and certification standards.
Development and implementation of systems to assure compliance with licensing requirements.
Ability to plan, organize, implement and evaluate complex administrative responsibilities.
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.
Director, Quality Assurance Jobs
By RxSense At , Princeton $105,000 - $158,000 a year
Prior management experience/Must have a demonstrated work history leading highly successful and motivated teams.
Experience in Pharmacy Business Management and/or Healthcare related fields a plus
Lead and coordinate quality assurance testing functions for Pharmacy Business Management across multiple functional areas, including Direct to Consumer platforms.
Should interact and collaborate with Innovation and Engineering team and report on high-level metrics for team management on status and progress.
Define department best practices, oversee personnel management, work with senior leadership on budget and hiring functions.
Participate in project requirement sessions, analyze and build test cases and prepare test plans
Director Of Quality Assurance
By TTEC At , Englewood
Support effective management of the QA process and related continuous improvements
12+ years of quality assurance experience
Proven leadership experience managing large, diverse global teams
BA/BS degree or equivalent work experience required
Financial acumen with experience managing own budget
Experience in a customer service environment or related position
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 Of Clinical Quality
By Aylo Health At Atlanta, GA, United States
Minimum 10 years professional experience in healthcare, with a minimum of 5 years in quality improvement.
Strong analytical skills with an ability to generate testable hypotheses and data-driven identification of drivers of performance.
Experience in use of population health tools and methods for engaging individuals and closing care gaps.
Plan, organize, and direct clinical quality activities.
Partner with external organizations to including payers to meet quarterly and annual clinical quality targets.
Develop workflows and cadence for managing measurement and improvement of identified metrics.