Clinical Quality Assurance Director Jobs

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

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

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.

UniSea offers a rich benefits package including:

Evaluate, mentor, and supervise departmental managers and supervisors.

Minimum of 6 to 9 years’ experience in seafood or other fisheries food quality assurance programs.

Excellent communication and organizational skills.

Hybrid work environment (2 days remote, 3 days in office)

Develop procedures, standards and guidelines for the QA department and their members to follow.

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.

5-10 years of experience in quality for HCT/Ps and/or medical devices

Bachelor’s Degree in a biological science or related field required

** Candidates MUST be US Citizen or Green Card Holder - No C2C or Sponsorship Available **

Recruit and manage a highly functional and motivated QA team.

BS or MS Degree in Computer Science, Information Science or related with equivalent experience

Experience leading quality and test engineering functions for large-scale products/services across server, web/SaaS, desktop, and mobile platforms

Experience with test automation and frameworks

Experience recruiting, leading and developing high-quality teams that produce results

Very strong communication skills, including an ability to communicate effectively to technical and non-technical stakeholders

Implement all relevant procedures directed by the Quality Director, for Management System (QMS) and ensure compliance

Undertake internal and process audits of the Quality Management System (QMS)

Manage contractors on site to ensure they meet legal and company requirements

Grounded with Finance, Business, Economics, Supply Chain, Operations & Technology or equivalent 15 years of experience

Manage the audit program and improvement activities, and play a key role in ensuring project deliveries.

Ensure that all in-house systems and procedures are updated, revised and modified to meet the needs of external certification bodies

Associates at Eurest are offered many fantastic benefits.

Must have F& B experience

Must have USDA and FDA experience

• Experienced in prepared foods manufacturing a plus.

• HACCP certification, Preventive Controls for Human Food (PCQI) and GFSI auditor certification a must.

• Working knowledge of food processing and distribution regulations, i.e. FDA and USDA/FSIS, and industry practice.

Demonstrated skills in project management and working with vendors and contractors.

Develop and reports Key Performance Indicators to measure CMO and Labeler performance and for contribution to Management Review.

Ideally 5 years of experience in leading the Quality Assurance function, preferably at the Director/Senior Manager level.

Minimum of 5 years related Quality Assurance experience in the Pharmaceutical/Biopharmaceutical/Biotechnology or Consumer Goods industry

Solid experience working within US and EMA GMPs.

Experience interacting with and responding to US and other Health Authorities.

Ensure a technical liaison between Quality and all other functional management groups in terms of operational objectives, with respect to quality.

Serve as Management Representative designee responsible for ensuring periodic management reviews of the quality system are conducted

Maintain robust CAPA, nonconformance, QMS electronic documentation and complaint management systems

Schedule and manage process and equipment validations and re-validation in accordance with established Standard Operating Procedures

Complete validation protocols and reports, and ensure compliance with all relevant Quality Standards and regulatory requirements

5 years of supervisory experience

Serves as the primary quality assurance resource for problem identification, resolution, and continuous improvement.

Instructs quality assurance personnel on quality control and analytical procedures.

Supports concurrent engineering efforts by participating in design development projects representing quality assurance and the customer.

Performs root-cause analysis and other problem-solving activities regarding nonconformance of products and processes to identify effective corrective actions and process improvements.

Communicates quality issues, trends and losses to all relevant organizational departments.

Interfaces with supplier and customer quality representatives concerning problems with quality control and assure that effective corrective action is implemented.

Work Experience/Requirements for This Role

Valid driver's license. SQF Practitioner or equivalent GFSI scheme experience, HACCP Certified (as appropriate)

Chemical Control, Product Quality Assurance, FSQA Customer Complaints, Food Defense and Security

Direct Employee Training of FSQA Programs, Policies, and Procedures

Direct Recall and Traceability Programs including Mock Recalls

Direct Independent FSQA Audit Program - SQF Audits

Working knowledge of USDA, FDA and GFSI requirements

Client offer a base plus bonus pay structure with strong benefits and paid time off

8 + years of related Quality Assurance experience in the food industry

5+ years of experience leading a team of both direct and indirect reports

Strong knowledge of HACCP, food safety, and SQF documentation, processes, and programs

Experience with Continuous Improvement programs and LEAN Manufacturing

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

·Must have strong knowledge of and broad experience in product Quality Assurance and Quality Control activities.

·Excellent interpersonal, organizational and communication skills

·Outstanding skills in managing vendors and others involved in Quality and Regulatory activities to meet corporate objectives

·Sound knowledge of a wide variety of biological, analytical, and instrumental disciplines

·Demonstrated leadership experience brining a biologics product to commercialization

·Extensive experience dealing with FDA in inspectional situations and response activities

Have an in-depth understanding and significant experience in GCP and compliance, leadership, communication skills, and business acumen to conduct responsibilities independently

Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines with an appropriate sense of urgency

Ensure functional area management reviews are conducted; prepare appropriate metrics and present significant events to senior management

Foster the development of operational technology and data management systems in support of facility performance, asset management, and operational excellence

Strong understanding of quality management systems in clinical development

Expertise in third-party and internal quality audits, issue management, and CAPA processes

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

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