Head Of Clinical Quality Assurance Jobs

Minimum of 5 years People Management experience

Ensures proper training and qualification of all Operational quality assurance associates in team.

Minimum of 7 years experience in the pharmaceutical or relevant industry experience

Related experience should be in GMP-regulated industries in quality assurance and/or compliance or equivalent experience

Related experience in supporting an operational quality assurance team

Familiar with Lab equipment Validation/Qualification Master Plan &Protocols is desired

Own and improve on our Quality Management System, including policies, procedures, and plans

Communication: Excellent written and verbal communication skills and experience working with customers and internal stakeholders

Support customer audits & qualifications

Ensure Egnyte meets regulatory requirements and GxP

Builder: Has experience implementing new processes alongside further improving existing quality processes and documentation.

Competitive salaries, comprehensive benefits & pre–IPO stock options

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.

8+ years of experience at high-growth managed services, marketplace, retail, finance or technology companies

2+ years direct management experience

Strong project management skills, with a demonstrated ability to prioritize various initiatives and deliverables

Lead and manage the team responsible for provider cross-state licensing, and ensuring all clinicians hold appropriate licensure in desired states

4+ years of experience on either talent acquisition teams and/or managing 100+ person growing teams of service providers

Experience managing teams towards KPIs and OKRs, and general fluency with operational data

Maintain quality standards/metrics & tracking set by the Crafco Quality Management System

Maintain appropriate records and files of data, instructions, and procedures in Quality Control Management System

BS degree in a technical or management field

Minimum of 5 years related work experience in Quality Assurance, quality certifications a plus

Knowledge on how to run all QC tests for sealant, roofing, silicone and patching materials

Manage external Crafco Technical Product documents (PDS, Installation Instructions, SDS), Certificates of Compliance

Proven track record of developing and implementing quality management systems in compliance with regulatory requirements.

Experience in leading and managing quality assurance teams, including hiring, training, and performance management.

Strong communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and senior management.

In-depth understanding of risk management practices and their application in the medical device industry.

Strong knowledge of class III Medical Devices

Excellent problem-solving and analytical skills, with the ability to make data-driven decisions.

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

Review and analyze quality trends with Alzheon management team

Evaluate the implemented corrective and preventive actions against trends and quality issues to assess effectiveness of the Alzheon quality management system

Support customer driven quality requirements and ensure vendors and supplier meet Alzheon’ s quality requirements

Firsthand experience of audits by regulatory authorities

Experience in hosting and leading FDA and other regulatory authority audits

Plan, direct implementation, and maintain an effective Quality Systems program in compliance with regulatory guidance and Pharmaceutical industry best practices

Strong experience in quality systems management and implementation.

Experience working within Dietary Supplements and/or Pharmaceutical manufacturing.

Extensive knowledge of the FDA code of Federal Regulations.

Lead both QA and QC teams to ensure effective Quality process.

Develop internal process and best practice.

Ensure regulatory compliance across multiple product categories.

10+ years' experience in Quality Management with several years in a biotherapeutics manufacturing setting

A proven track record of leadership, people management, and effective interpersonal and communication skills

Manage, develop, and build the Quality team and its capabilities

Deep knowledge of cGXP requirements, with an understanding of phase-appropriate clinical and commercial expectations

Lead the expansion of the QMS, including strategic implementation of electronic systems to support internal CGMP capabilities for our LBPs

BS/MS in a relevant scientific discipline (e.g., Microbiology, Biochemistry), 15+ years of relevant professional experience

Will be responsible for building and driving business transformation capabilities across clinical value chain

Should have prior experience on creating business strategy and roadmaps and driving it though implementation.

Should have prior experience in driving business transformation and creating Point of views.

Strong communication skills: should be able express his thoughts in a clear and concise manner

Years of experience required for position – 20+ years

Should be able to build connect at CXO level and present business transformation strategies and solutions