Clinical Quality Assurance Director Jobs

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.

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.

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

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

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.

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)

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

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.

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.

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.

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.

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.

Sekisui Diagnostics offers a competitive compensation.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

To be successful in this role

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.

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.

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.

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

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