Director, Quality Systems Job Description

Director, Quality Systems Job Description

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Director, quality systems provides quality Systems compliance support and guidance in order to maintain compliance with all FDA, ISO 13485 and other regulatory requirements.

Director, Quality Systems Duties & Responsibilities

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

Sample responsibilities for this position include:

Works with senior management to develop regulatory strategies for FDA approvals
Manages the Quality and Regulatory personnel to ensure quality system compliance with all state and federal regulations, to include the hiring process and performance appraisal
Responsible for regulatory guidance to the company’s product development teams
Manages the correspondence and other records of all interactions with regulatory agencies
Directs the Policy and Procedures of QSR (Quality System Regulation) Quality System, and oversees the company-wide training and implementation of them
Ensure audit and inspection responses are submitted to the proper regulatory agencies
Oversee the departmental Quality Assurance program
Ensure that all deficiencies have the appropriate plan of correction implemented and sustained
Ensure that quality system practices are standardized across all pathology laboratories
Keep abreast of the evolving regulatory policy and industry best practices related Quality systems

Director, Quality Systems Qualifications

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

Licensing or Certifications for Director, Quality Systems

List any licenses or certifications required by the position: ISO, ASQ, PAL, MDR, 9000, FDA, 9001, RCA, IVDR, MDSAP

Education for Director, Quality Systems

Typically a job would require a certain level of education.

Employers hiring for the director, quality systems job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Science, Life Sciences, Education, Technical, Chemistry, Business, Biology, MBA, Management

Skills for Director, Quality Systems

Desired skills for director, quality systems include:

GMP
Aseptic manufacturing processes
Change control practices/strategies
Quality systems and regulatory requirements
SOPs and quality systems
ISO 13485
MDD
Biologics
CGMPs
CMDCAS

Desired experience for director, quality systems includes:

Provide expert advice to leadership and functional area managers on QA related issues, including those with company-wide or external impact
Provide QA input and resources to author, review and finalize quality-related documentation
Lead Quality System Management Review meetings with leadership
Identify and suggest functional improvements to the Document Control and Quality Assurance systems
Manage and support Quality and validation software (Master Control, Trackwise, and all other related tools/technologies to support company needs in this area)
Oversees IT Quality and Compliance management to ensure internal standards and procedures for Computer System Validation remain effective at delivering compliant IT solutions

Director, Quality Systems Examples

1

Director, Quality Systems Job Description

Job Description Example
Our growing company is looking to fill the role of director, quality systems. 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 systems
  • Establish and oversee an independent escalation method to support global GxP CAPA governance
  • Appropriately escalate individual CAPAs at risk and/or negative trends in Key Performance Indicators to the appropriate forums and management
  • Interact with key senior leaders to maintain executive awareness of GxP CAPA performance
  • Oversee the planning, execution and delivery of CAPA strategies/plans for the remediation, correction and prevention of recurrence of those significant quality events with broader impact across the Janssen R&D QMS
  • Drive investigation of large scale significant quality events, including the identification of issues, impact assessment, root cause analysis, oversight of appropriate communication and escalation to senior leadership, as appropriate
  • Establish defined thresholds enabling the tracking/trending of escalated issues across the QMS holistically inclusive of CAPA escalations to leadership councils or forums
  • Develop CAPA trending capabilities, enabling the identification of systemic root causes leading to the implementation of solutions to eliminate root causes
  • Establish and drive the use of accurate and actionable metrics for clearly identifying areas of risk, performance to commitments, effectiveness and timeliness of GxP CAPAs
  • Ensure the effective functioning of CAPA system/process to eliminate the causes of detected discrepancies (reactive), and preventive actions are in place to eliminate the causes of potential discrepancies of other undesirable situations (proactive)
  • Lead a team and contribute to the effective and accurate implementation and delivery of global Good Clinical Practice (GCP) CAPA management in Janssen R&D
Qualifications for director, quality systems
  • Demonstrated success leading cross-functional development, implementation, application, and maintenance of Quality Systems
  • Well versed with regulatory compliance (GxP, 21CFR Part 11, EU Annex 11 )
  • Experience with conducting risk assessment and knowledge of current industry good practice for risk assessment methodologies and tools, , GAMP-5, NIST, ICH
  • A minimum of 10 years of experience in a medium to large scale matrix organization is required
  • Experience managing staff, developing future quality leaders and building an organizational culture is required
  • Ability to effectively operate in a matrix environment and influence and interact with senior enterprise leaders and functional leaders on a regular basis is required
2

Director, Quality Systems Job Description

Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of director, quality systems. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for director, quality systems
  • Manages and provides oversight of Acorda’s QMS to ensure that the Quality Systems are in compliance with applicable GxP regulations and company procedures
  • Manages QA associates involved in computer systems validation and implementation and operation of electronic quality management systems, including document management and learning management systems
  • Leads and manages QMS cross functional teams to identify issues or gaps and to direct appropriate corrective and preventative actions as needed
  • Performs periodic review and audits of the QMS to document and report gaps and risks
  • Functions as the Business Owner for the Acorda electronic document management system
  • Responsible for quality oversight in the area of GxP document management and retention
  • Collaborates and provides quality oversight of third parties contracted to perform any functions in support of the GxP regulated validation projects
  • This individual supervises a team of associates in the Quality Assurance department
  • Develops and implements a risk-based audit programs that meet regulatory requirements
  • Drives the development and continuous improvement of compliance initiatives
Qualifications for director, quality systems
  • The ability to combine business needs with functional objectives is required
  • Expert knowledge in global GxP compliance regulations governing clinical development activities is required
  • Expert knowledge in global GCP compliance regulations governing clinical development activities, and thorough knowledge of worldwide GxP regulations is required
  • Experience in operational activities in a compliance environment is required
  • Expert knowledge of quality and risk management terminology and proficient knowledge of scientific terminology required
  • Bachelor’s degree from an accredited university in Nursing, Healthcare Marketing or Public Health required
3

Director, Quality Systems Job Description

Job Description Example
Our company is looking for a director, quality systems. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for director, quality systems
  • Leads the Policies and Standards Steering Committee responsible for the creation, review and approval of Pharmaceutical Development & Manufacturing (PDM) standards, policies and SOPs
  • Providing the necessary support of the global escalation process
  • Coordinates the periodic review of key Quality Systems on a global basis and recommends areas of improvements
  • Oversees the group responsible for the establishment of Key Quality metrics across the Gilead network
  • Oversees the regulatory intelligence function responsible for providing visibility to emerging regulatory trends and provides recommendations on how Gilead should react to these trends
  • Oversees the group responsible for providing QA support of IT functions for GXP systems
  • Provides organization support through the use of the Quality Engineering function
  • Provides necessary support during regulatory/customer inspections at Foster City
  • Manages the Quality Policy Systems group
  • Maintains the PDM Quality Plan
Qualifications for director, quality systems
  • BS degree -required in chemistry, microbiology or chemical engineering
  • Incumbent needs to possess excellent people skills to influence, motivate, teach and encourage direct staff peers to understand and accept his/her
  • Master's degree in a scientific or health related field preferred
  • Advanced understanding of the application of FDA regulations and ICH guidelines is required
  • Expert knowledge of Quality Management Systems, and prior experience of QMS participation
  • Expert knowledge of computer system validation requirements per 21 CFR part 11 Electronic Records and Signatures and other applicable regulations and guidance
4

Director, Quality Systems Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of director, quality systems. 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 systems
  • Analyze and continually improve the quality process
  • Replacing, updating, and enhancing Quality Related IT systems and databases
  • As an owner of Corporate Quality and Regulatory electronic applications, design and continually update workflows for document control, change control, non conformances, complaint handling, MDR’s, vigilance reports, corrective and preventive actions, audits, training, Corporate metrics and product registrations
  • Leads and manages QMS cross functional teams to improve quality processes and procedures, identify issues or gaps and to direct appropriate corrective and preventative actions as needed
  • This individual supervises a team of associates in the Quality Assurance department, including document control, training and computer system validation functions
  • Manage and direct the technical service staff to achieve the goals and costs established to provide quality refined fuels and lubricant products to our customers
  • Develop product formulation strategy and costs
  • Lead the development and implementation for the quality systems at our three lubricant manufacturing plants and Cenex branded distributors
  • Provide strategic policy for product quality to support both lubricant, refined fuels staffs and our customers
  • Provide technical expertise to Refined Fuels on product quality, specifications and problem resolution
Qualifications for director, quality systems
  • Working knowledge of local Regulations
  • The ability to find new ways to come to the same goal and pragmatic advising striving for the optimal solution ensuring compliance in a cost-effective way required
  • Must have at least 2 years of experience in healthcare clinical or quality improvement and in building and managing relationships with external alliances
  • Maintains professional expertise and knowledge of local and international regulations
  • Must be proficient in MS Office Suite and QUMAS and familiar with other electronic systems as used in pharmaceutical industry environment
  • Good interpersonal skills, ability to interact effectively with all levels of personnel within the organization and externally with investigators and study site personnel
5

Director, Quality Systems Job Description

Job Description Example
Our company is searching for experienced candidates for the position of director, quality systems. 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 systems
  • Direct and manage the Lubricant’s EHS (environment, health and safety) compliance systems at our manufacturing plants
  • Work with Director of Manufacturing and Plant Managers to achieve manufacturing plant budget, safety and quality goals
  • Provide direction to meet and improve plant procedures developed to meet customer requirements and quality standards
  • Develops and oversees implementation of procedures and methodologies within IT
  • Key stakeholder in the definition and development of the 3 year IT Strategic Roadmap, in collaboration with the business and IT Leadership – including development of the annual IT Roadmap planning process, and associated project budgets
  • Assure audit plans address defect trends
  • Serve as liaison for stakeholder relationships impacting program goals such as Departments of Health or Quality Improvement Organizations as assigned
  • Manage stakeholder relationship through task forces, conferences and individual consulting
  • Coordinate and conduct account management activities in markets, including implementation and quality improvement consulting for hospitals collecting stroke, heart failure, a-fib, resuscitation and STEMI/NSTEMI data
  • Market and implement the programs, including the Patient Management Tool (PMT) and ACTION Registry-GWTG (ARG)
Qualifications for director, quality systems
  • Ability to review documentation, processes and procedures as it relates to Acorda’s QMS, identify issues/problem areas
  • Strong ability to prioritize tasks and keen attention to detail
  • Demonstrated leadership, organizational and project management skills
  • Extensive experience with design, implementation, management and continuous improvement of electronic and physical record document management systems and practices
  • Demonstrated proficiency with PC-based office computers and standard Microsoft Office applications
  • Demonstrated ability to maintain current knowledge of applicable regulations and other regulatory changes

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