Clinical Quality Assurance Manager Jobs

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

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

Project Management experience is a must

Quality event management experience is a must

Ensures final endorsement of document(s) prior to coordinating approval workflows in the Document Management System (DMS).

Typically requires 8-10 years of experience, or the equivalent combination of education and experience, in the biopharmaceutical industry

Sponsor/CRO GCP experience required (experience in a Clinical Project Manager role is ideal)

Strong interest and understanding of Process/Controlled Document Management – this can be trained for the right person

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.

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

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.

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.

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

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.

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

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.

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.

Quality Improvement and project management training/experience

Partner closely with health centers and Yuvo performance managers to drive positive outcomes.

Experience using Microsoft Excel for data organization and use of other data platforms

Experience working with federal and state developed metrics to drive health organization improvement

Experience working with various types of health organizations

Experience working in an early-stage startup

Quality Improvement and project management training/experience

Management and oversight of automated population health solutions and electronic systems reporting.

Manage internal and external partner relationships across multiple departments and external organizations.

Partner closely with health centers as well as performance managers to drive positive outcomes

Experience working in or with primary care organization and conducting outreach to improve engagement in care

Experience facilitating teams in improvement initiatives

Bachelor’s degree or equivalent in relevant health care area. Advanced or formal education in quality management or business management is preferred.

Knowledge and background in clinical development programs, clinical trial processes as well as quality management systems and quality control tools.

Experience with delivering effective CAPA management solutions.

Experience with risk management tools and processes within the clinical quality framework.

Excellent project management and organizational skills.

Escalate potentially significant inspection findings/compliance risks/impact to our Company Senior Management.

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

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)

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

Generates reports as requested by management (i.e., accuracy, quality).

Intermediate computer skills (e.g. Microsoft Office, Outlook, Internet search) and experience with health care systems and documentation (EMR, billing and claims).

Strong analytical and problem-solving skills.

Demonstrated experience with writing, documentation, and editing.

One-time furniture and equipment allowance for employees working from home

Remote within WA, ID, OR, and UT