Global Director Of Quality Jobs

2+ years of formalized leadership/management experience.

7+ years of Quality Engineering experience within manufacturing environment(s).

Serve as organizational Quality SME, defining and driving quality assurance strategies that properly support product development and process implementation.

Direct and develop QA and QC personnel for the site.

Lead internal and external auditing activities.

Identify, track, and act upon quality metrics and KPIs.

In depth knowledge of the Quality Management Systems

Strong people management and leadership experience

Subject Matter Expert with all aspects of quality management

**Exact compensation may vary based on skills, experience, and location.

*Exact compensation may vary based on skills, experience, and location.

Review and assure compliance with contractual requirements and regulatory requirements.

3rd party Quality certification (ISO 9001/TS 16949) experience, preferred.

Evaluate new and existing regulations to ensure the quality assurance protocols fulfill requirements.

Six Sigma Black Belt certification preferred.

Experience with the manufacturing of windows and doors is preferred.

Progressive experience in quality technical field and leadership roles, preferably in manufacturing.

Excellent verbal and written communication skills with the ability to train staff.

Must have experience establishing defect management standards and processes that align with best practice testing methodologies.

Must have a strong background in establishing and overseeing quality management systems and processes, such as QS and ISO 9001:2010.

This position will oversee the company’s quality management system and monitor progress against strategic quality-related goals.

This position will establish defect management standards and processes that align with best practice testing methodologies.

Position Critical to Quality + Success (CTQ+S): Skill/Ability Behavioral Requirements:

Must have at least 5+ years' Quality leadership experience in a manufacturing environment.

Demonstrated knowledge of quality tools and methodologies, lean foundation elements, continuous improvement and change management

Requires strong communication, and organizational and time management skills

Minimum four years process improvement or quality management experience in healthcare

Laboratory experience preferred. Progressive quality and performance, leadership supervision or project team management required

Incorporates CLSI’s quality system essentials and applicable CLSI standards and guidelines into PLMI quality management system, as appropriate.

A Master’s Degree may offset two years of the experience requirement

Possess / Maintain IATF 16949 Lead Auditor certification to meet 2nd party audit requirement

Experience supporting global products and global launches

Experience speaking and presenting to C-level executives at customers and strategic partners

Demonstrated experience working in a fast-paced and entrepreneurial organization; results-oriented with a sense of urgency or passion

Excellent organizational, leadership, interpersonal and problem solving skills

Must possess human relations, leadership skills and maturity of judgment

Strong leadership experience not limited to mentoring, project management, and training of QA related personnel.

Manage and mentor Quality management staff to promote personnel development and succession planning.

Manage the implementation/maintenance/continuous improvement of Quality Systems.

8-10 years of Quality experience in the Medical Device industry, with a minimum of 5 years in a leadership position

The Director – Quality Assurance has the following qualifications:

Location: Dallas – Fort Worth

Quality Leadership and management experience in automotive or aerospace, commercial and defense hardware and software technology risk management

Collaborate with senior leadership for planning, execution, and management of process improvements, projects, and other initiatives

Lead integrated senior management teams to determine strategy and tactical deployment, improve performance, lower costs, and generate innovative solutions

Lead management review meetings annually, and more frequently as required, regarding compliance with QMS and Global Quality Policy.

Ensures that all responsibilities and functions performed are in accordance with company procedures and meet quality standards in place.

Manages all operations and personnel in the Quality Assurance Department

Interact with quality and site management on the performance of quality systems.

Interact internally and externally with quality and site management to report on the performance of the quality system.

Demonstrate the ability to incorporate sound risk management fundamentals in the establishment of QMS

Maintain current knowledge of national and regional regulations regarding QSR, ISO, MDD, and quality assurance issues as they impact PSG QMS.

Minimum of 15 years’ experience in multinational pharma/biopharma organizations, covering multi-site quality systems, and quality operations roles with global experience.

Experience in strategy development and deployment, organisational change, and business improvement.

Own all quality initiatives throughout the global organization through oversight and management

Challenge the management and boost lean best practices within the organization

Collaborates with management and senior staff across departments

Functionality, and other specifications and requirements

Contribute to the “lean thinking” education of all the employees and champion ‘lean thinking’ culture

Manage and coordinate the Quality KPI’s

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

Strong project management skills, with the ability to prioritize and manage multiple initiatives simultaneously.

Stay abreast of global regulatory requirements and changes in quality standards for medical devices.

Recruit, train, and develop a skilled and motivated quality organization.

Deep knowledge and understanding of global quality regulations, standards, and guidelines, such as FDA regulations, ISO 13485, and MDR.

Proven experience in implementing and managing quality systems and processes in a global organization.

Strong leadership skills with the ability to influence and engage stakeholders at all levels of the organization.

At least 5 years' experience in quality, operations, design engineering, manufacturing, and/or general management experience.

Bachelor’s Degree in relevant field or equivalent experience required, Masters Degree preferred.

Knowledge of Quality systems including ISO and IATF.

Automotive OEM experience preferred, which includes previous contact with OEM Automotive customers.

o New Product Introduction – ensuring that new products meet the requirements of the customers

o Supplier Development – ensuring that suppliers meet PPG requirements to provide quality materials

Several years of Quality industry experience;

Strong technical knowledge in Quality Systems.

Minimum BSc preferably in Sciences or Engineering;

Harmonize and maintain the Notification to Management and recall process across GxPs.

Demonstrated ability to apply effective risk management approaches that provide a proactive means of identification and control of potential quality issues.

Manage direct reports’ day to day work as well as performance oversight and support staff development efforts

10+ years of GMP/GDP Biologics and Pharma experience

Experience leading or supporting commercial manufacturing sites through global health authority inspections is desirable.

In-depth knowledge of quality systems principles and applications.

Exceptional project management skills, including establishing measurable standards and comparing with actual results

Skilled at generating detailed and timely reports and presentations for management review

Education: bachelor's degree in engineering, Quality, Supply Chain, Business Administration, Process Management, or a related field required; master’s degree preferred.

Ten years or more of experience working with suppliers

Experience leading team of high performing teams

Experience as a change agent at multiple organizational levels

Support site quality management at sites with any escalations internally or from customers

Effectively communicate & present information to all levels of the organization – shop floor, direct reports, and management.

Working knowledge and development of quality systems and requirements and how they relate to business (i.e. AS9100, NADCAP).

Led effort of one AS9100 global certification

Bachelor’s Degree Engineering desired or relevant experience

Minimum of seven years of quality related experience

Interact with quality and site management on the performance of quality systems.

Interact internally and externally with quality and site management to report on the performance of the quality system.

Demonstrate the ability to incorporate sound risk management fundamentals in the establishment of QMS

Maintain current knowledge of national and regional regulations regarding QSR, ISO, MDD, and quality assurance issues as they impact PSG QMS.

Minimum of 15 years’ experience in multinational pharma/biopharma organizations, covering multi-site quality systems, and quality operations roles with global experience.

Experience in strategy development and deployment, organisational change, and business improvement.

Time management skills – ability to effectively manage within tight time frames

Personnel and organizational management programs, including DEI ensuring standardization of common needs globally across platform

Director, Global Quality Management JSCQ role

Manage and organize communications with JSCQ teams, townhalls and special messages

Minimum 10 years’ experience in regulated industry with strong experience in Quality and Compliance

Fundamental knowledge of pharmaceutical manufacturing processes