Director, Quality Management Job Description

Director, Quality Management Job Description

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Director, quality management provides education in the areas of nursing competency, continuous process improvement, infection control, employee health, safety, case management, and program evaluation.

Director, Quality Management Duties & Responsibilities

To write an effective director, quality management job description, begin by listing detailed duties, responsibilities and expectations. We have included director, quality management job description templates that you can modify and use.

Sample responsibilities for this position include:

Responsible for the development and motivation of staff and provide them with leadership, counseling and career guidance
Lead development of CAPA centralized tools and process training
Responsible for determining appropriate tools, automation, processes, industry standard methodologies and techniques to apply to application development projects
Manages development of a integrated solutions to resolve highly complex technical and business objectives
Review large scale distribution center projects at critical mile stones, such as design completion, system commissioning and prior to go-live, with the objective to identify business risks in terms of ability to maintain customer service levels to fulfil the planned business cases
Position incumbent is responsible to provide executive management and steering board with a clear view on business readiness, risks and improvement opportunities of large scale DC projects
You will lead the definition and maintenance of risk data and risk reporting quality strategy standards, analysis, design and implementation of RDARR quality measures thresholds, rules and controls
You work collaboratively with Risk Owners and Subject Matter Experts (SMEs) in Group Risk Management and Corporate Treasury to understand their needs and lead the analysis and design of data quality and data insight approaches
You will support other areas in the Risk CDO and Business & Corporate Support Segments in understanding the data quality standards, measures and any key insights from profiling of their data
You will lead and mentor a team of Risk Analysts in the analysis, data quality measurement and profiling of data

Director, Quality Management Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Director, Quality Management

List any licenses or certifications required by the position: ISO, LEAN, CPHQ, 9001, PMP, ASQ, ITIL, NIMS, CQE, RCA

Education for Director, Quality Management

Typically a job would require a certain level of education.

Employers hiring for the director, quality management job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Education, Nursing, Health, Engineering, Management, Healthcare, Business, Science, Business/Administration, Allied Health

Skills for Director, Quality Management

Desired skills for director, quality management include:

Staff development and the educational process
Quality improvement
Safety/risk management standards
Regulatory changes pertaining to Quality Assurance/Performance Improvement activities
Infection control/employee health
Infection control/employee healthy
Aging process for the planning and delivery of age-appropriate care
Development
Growth
Global health authority regulations and requirements

Desired experience for director, quality management includes:

You will support IT Partners in the implementation and maintenance of RDARR Quality Measures architecture, systems & processes including decisions on data sourcing staging layers and optimal data flow
Ensure quality programs continue to evolve to support changing business objectives and goals
Provide national leadership in all things quality and performance management related, ensuring key stakeholder positions are understood, considered, and managed appropriately
Promote the health of all quality and performance management programs through regular assessment, calibration, and program adjustment
Be an advocate for the front-line agents, supervisors, and quality assurance professionals
Ensure that all quality and performance management programs are supported by a best-in-class, standardized tool set (wherever possible) across the enterprise

Director, Quality Management Examples

1

Director, Quality Management Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of director, quality management. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for director, quality management
  • Work closely with the QA Global Leaders of Supplier Development and design controls, Regulatory Affairs, Clinical Affairs, and Legal to provide regulatory training, guidance and controls to the commercial, R&D, and Engineering organizations
  • Leading and implementing initiatives and programs in Quality and Risk assessment, monitoring and dealing and reporting to leaders across the firm
  • Working autonomously, capable of day-to-day management of people and projects, think strategically and participate in project planning efforts
  • Able to manage within budgetary and time constraints while providing a high-level of internal and external client satisfaction
  • Reporting to Quality and Risk Management Leader(s)
  • Directing and driving the success of multiple projects
  • Develop and facilitate mechanisms/processes to identify potential gaps or opportunities for improvement and recommendations to improve the QMS
  • Establish a process enabling cross function/discipline/segment identification and promote knowledge sharing of information, systemic issues, mitigation strategies and successful outcomes from the strategies
  • Develop, implement and manage the process to gather, store and retrieve best practices/lessons learned for Janssen R&D QMS
  • Partner with organizations, functions, and process owners to drive strategies for quality and optimal process performance of GxP activities
Qualifications for director, quality management
  • Strong leadership skills with demonstrated competency interfacing with senior leaders, strong networking and relationship building skills and a proven track record of leading and developing people is required
  • Fluency (both oral and written) in English is required
  • Provide sponsorship and may act as lead of quality focused continuous improvement projects or programs aimed at overseeing quality processes relevant to pillars in scope of the R&D QMS and effectively responding to quality issues identified as a result of the QMS oversight
  • Support improved understanding and performance of the R&D QMS through assessments of system interdependences specifically leading to the identification of predictive measures that proactively enhance all elements of quality
  • Generate regular and ad hoc status reports on the state of the QMS control, system health and provides meaningful interpretation of trends and signals identified
  • Review effectiveness of dashboards and dashboard metrics to improve meaningful utility to owners, governance bodies and senior leadership
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Director, Quality Management Job Description

Job Description Example
Our company is growing rapidly and is hiring for a director, quality management. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for director, quality management
  • Aids in the creation of product portfolio guidelines on the control strategy for new products which will influence the development strategy and the total quality cost during commercial production
  • Overseeing development and implementation of Clinical Operations SOPs
  • Participates in the development of and ensures the effectiveness and efficiency of the agency’s investigative operations and ensures that the agency meets its mission to provide quality investigations in a timely manner
  • Performs quality assurance reviews by identifying and ensuring continuous quality improvement of investigative process within the squads
  • Work collaboratively across the organization to drive the quality culture
  • Oversight of staff that conduct actions according to Federal, State and Corporate policies including HIPAA, HITECH, Personal Health Information (PHI) and Personal Identifying Information (PII)
  • Serve as a critical role in the BioResearch Quality & Compliance (BRQC) Janssen organization to ensure the efficiency and effectiveness of the corrective and preventative action (CAPA) process
  • Lead and contribute to the effective and accurate implementation and delivery of global GxP CAPA management in Janssen R&D
  • Have end-to-end accountability for the quality strategy and quality aspects of commercial products for an assigned portfolio of products
  • Partner with key stakeholders to resolve complex non-compliant issues by the most efficient and effective methods
Qualifications for director, quality management
  • Limited travel to international operational sites may be required
  • Minimum 8 years of experience in a QA leadership and management roles with direct management responsibility for QA personnel and responsibility for a broad spectrum of Quality System elements
  • Current Maryland Licensure as Registered Nurse
  • Five years as Registered Nurse
  • Two years in Quality Management
  • Must represent the company in a professional manner to outside entities
3

Director, Quality Management Job Description

Job Description Example
Our company is growing rapidly and is hiring for a director, quality management. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for director, quality management
  • Provide advice on changes and implementation of Quality systems providing training tools and techniques necessary for others to achieve quality practices
  • Collaborate with other departments to ensure compliance with national and international standards and legislation and maintain strong working relationship and communications with global commercial, operations, and regulatory heads
  • Ensure post-market product regulatory compliance, demonstrated by timely, consistent review of customer, minimizing the risk of government authorities’ actions that could impact the company’s business
  • Establish company-wide internal Quality audit program and define sustainable and effective audit schedule and audit plans
  • Participate in investigations of quality system issues and ensure CAPA findings, risks, recommendations, and outcomes are appropriate and are clearly documented and communicated
  • Trend, analyze, and report on quality data in order to improve product and process
  • Represent company in various agency and industrial conferences
  • Develop and maintain primary monitoring and control systems, related tools, processes, and procedures, including the management of internal metrics, and management and oversight of the Janssen Scientific Affairs (JSA) CAPA system
  • Be responsible for facilitating awareness of regulatory and company compliance regulations, establishing a state of on-going Inspection and Audit Readiness, providing support for internal /external audits and inspections, and providing oversight of Corrections, Corrective and Preventive Actions (CAPAs) following audits and inspections
  • Identifies and provides knowledge of quality systems to minimize compliance risks while balancing business needs
Qualifications for director, quality management
  • Master’s degree in Science/Life Science from an accredited institution required
  • Graduate caliber candidate with a scientific background, a quality related discipline
  • Significant experience in continuous improvement
  • Wide network and in-depth knowledge of best practices / benchmark information of medicine auditing in the industry
  • Outstanding leadership, communication, internal consulting skills
  • Experience in leading cross-cultural team, ideally with experience in line management or with project team management
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Director, Quality Management Job Description

Job Description Example
Our innovative and growing company is looking for a director, quality management. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for director, quality management
  • Quality Management subject matter expert who provides real-time, proactive advice and guidance on procedures and issues relating to Quality, Compliance and Global Processes related to clinical development program management, clinical trial activities and vendor oversight
  • Attend QP&S Leadership Team meetings as needed to discuss risks and opportunities and plan resources to support process updates, training and development, system changes or upgrades, or other enhancements needed to maintain the framework and IQP template
  • Oversees and guides the JSA CAPA Champion Network within JSA business functions, including onboarding to the Trackwise Quality Management system and knowledge transfer of tools to manage nonconformances
  • Monitors, supports, and maintains the JSA quality issue management/CAPA program by coordinating and overseeing processing of quality issues and non-conformances
  • Ensures appropriate documentation records in the Trackwise system
  • Responsible for initial quality approval of records in Trackwise monitoring for completion of root cause investigations, CAPA implementation, closure and effectiveness checks
  • Serves as the Chair of the JSA monthly CAPA Review Board, facilitating quality issues and CAPA oversight, timely completion of quality records, proactive escalation of records in jeopardy of missing closure milestones and identification of resource issues
  • Develops, monitors, and reports on internal compliance metrics, ensuring appropriate management oversight and escalation of compliance risks per company standards and /or in support of Management Review
  • Facilitates an awareness of regulatory and company compliance requirements within JSA
  • Facilitates and oversees the JSA state of on-going readiness for internal and/or external audits and Health Authority Inspections
Qualifications for director, quality management
  • Auditing experience in Medicine area (at least 10 years) with in depth international experience across all audit areas from industry, CRO or GCP compliant hospital environment
  • In-depth knowledge of regulatory requirements / expectation gained from auditing, inspection activities
  • Minimum of 7 years of related pharmaceutical industry or Clinical Research Organization experience including at least 4 years of document and process quality management and/or quality assurance experience
  • BA/BS or equivalent degree preferably in life sciences or allied health field
  • At least 10 years of global experience working in quality assurance or quality management
  • Strong experience authoring policies and procedures in the pharmaceutical/biotech industry
5

Director, Quality Management Job Description

Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of director, quality management. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for director, quality management
  • Provide guidance to strategic planning, prioritization, and development of operational initiatives, implementation, and evaluation of initiatives and projects to ensure effective use of resources
  • Leads/coordinates the logistical and administrative support for internal/external audits and Health Authority Inspections including management of pre-Audit requests and Audit Sharepoint documentation
  • Prepares Key Contacts, Subject Matter Experts (SME) support personnel for audit readiness and oversees the staffing for the back room according to JSA internal procedures
  • Directs the back room during audits and ensures prompt response to requested information during the audit conduct
  • Manage multiple scrum teams
  • Develops, identifies and analyzes data and information for division-wide QM/RM initiatives
  • Monitoring performance of Clinical Operations relative to applicable Policies, SOPs, Work Practices and Study Plans to evaluate compliance
  • Serving as a Clinical Operations subject matter expert (SME) on matters of clinical quality to ensure “inspection readiness” of the Clinical Operations function and its vendors/CROs as required
  • Spearheading continuous improvement activities to implement best practices and enhance compliance
  • Assisting in selection of clinical operations vendors, monitoring their performance and resolving quality and performance issues
Qualifications for director, quality management
  • Knowledge of Computer System Validation requirements and clinical systems
  • Experience managing and collaborating in a team/matrix environment
  • Strong collaboration skills and experience working with teams cross functionally and globally
  • Acts as an active member of peer review committees
  • Ability to interface with various external and internal stakeholders (different functional background, different levels) and engage in a constructive solution oriented manner
  • Ability to identify opportunities to increase efficiencies in processes

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