Manager, Quality Systems Job Description

Manager, Quality Systems Job Description

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Manager, quality systems provides guidance to management staff on the integration of FDA regulations, ISO standards, and industry expectations into the Quality Management System (QMS).

Manager, Quality Systems Duties & Responsibilities

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

Sample responsibilities for this position include:

The creation of Gap Analysis tools related to the Global Quality Standards
Oversight and assistance in the performance of Gap Analysis activities for new or revised standards
Responsible for working with the Business Process Owner(s) to collect data for systems including but not limited to Documentation and Quality Standards
Provide support for all regulatory inspections and audits , US FDA, EU, Notified Body for CE Mark, State Food and Drug, and partner audits
Develop quality management programs and manuals for various labs, in compliance with the goals and objectives of the Divisions management
Review, Maintain, and update the general administration policy manual in order ensure that the current and standardized procedures are followed
Order and coordinate participation in proficiency testing programs for all labs
Organize and maintain proficiency testing results, including documentation of the follow up, and initiate and tracks 'root cause' or 'failure, mode and effects' analysis when indicated
Design and implement audit plans to continually assess quality of service provided and improve outcomes
Maintain audit reports and documentation of audits performed, including documentation of corrective action and measures of success

Manager, Quality Systems Qualifications

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

Licensing or Certifications for Manager, Quality Systems

List any licenses or certifications required by the position: ISO, QMS, 9001, TS, ISO9001, ASQ, A.S, EFFCI, BRC, USP

Education for Manager, Quality Systems

Typically a job would require a certain level of education.

Employers hiring for the manager, 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, Technical, Chemistry, Education, Management, Biology, Business, Manufacturing, Microbiology

Skills for Manager, Quality Systems

Desired skills for manager, quality systems include:

ISO 13485
FDA
System integration
Concepts
Good Manufacturing Practices
Industry practices
Standards
MDD

Desired experience for manager, quality systems includes:

Select, develop, and evaluate personnel to ensure the efficient operation of the Quality Systems group
Experience with systems and process testing
Experience working and/or managing in an Operations capacity
Document owner for the Technical Operations Quality Manual including revision control and inspection support
Responsible to ensure Quality Statement is posted at Shire sites as appropriate
Create metrics reports which are clear and based on source data

Manager, Quality Systems Examples

1

Manager, Quality Systems Job Description

Job Description Example
Our growing company is looking to fill the role of manager, quality systems. 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 manager, quality systems
  • Partner with Quality Assurance to ensure completion of Annual Product Review for OTC products
  • Participation in the Quality Management Review to MANCOM
  • Perform internal audits (when necessary)
  • Management of Quality indicators and data reporting to corporate (DGO/CIQ)
  • Analysis and trending of quality indicators
  • Actively engaged in safety programs (MESUR, SIO)
  • Provide leadership and strategic oversight of the Drug Enforcement Agency (DEA) programs for McNeil and its affiliated organizations
  • Provide leadership guidance to the manufacturing, packaging and distribution operations concerning import/export requirements, suspicious order monitoring, internal and external DEA audits of operations that deal with listed chemical products
  • Work with business partners to develop and maintain a robust process for submission of annual quota requirements to assure compliance with current DEA regulations and requirements
  • Responsible for managing batch record review and approval to ensure agreed upon timelines are met and approving responses to client batch record review comments
Qualifications for manager, quality systems
  • Requires the ability to meet deadlines, have good organizational skills and have the ability to work independently
  • Requires ability for test design and interpretation of results
  • Must have strong communication skills, presentation skills, writing skills, and excel skills
  • Review and approval of site procedures related to manufacturing and production activities
  • Negotiate Quality Agreements and ensure compliance
  • Review and approval of facility, equipment and computerized system validation documents
2

Manager, Quality Systems Job Description

Job Description Example
Our company is looking to fill the role of manager, quality systems. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for manager, quality systems
  • Utilize accurate and actionable metrics to identify areas of risk, performance to commitments, effectiveness and timeliness of GxP CAPAs
  • Manage notification and/or escalation of emerging and signification risks to the relevant senior management and governance bodies, as appropriate
  • Responsible for Preparation and the Management support of external Regulatory, Division and Corporate audits within the plant
  • To manage other Q.A
  • Lead a group of quality professionals to manage investigations and change controls for External Manufacturing
  • Be the External Manufacturer Quality Agreement Site Process Owner and will be responsible for the administration, effectiveness and continuous improvement process for Change Controls, Investigation/CAPA and Quality Agreements systems
  • Support internal audit and external inspection support, preparation and coordination of management notification/escalation
  • Develop and execute improvement strategies to increase program efficiencies and to decrease risk profiles
  • Be responsible for meeting McNeil Consumer Healthcare (MCH) U.S. requirements as outlined in the approved Quality Agreement between MCH U.S. and NA Source Quality
  • Identify and assess risk associated with North America Source Quality, MCH, systems and processes
Qualifications for manager, quality systems
  • Manages conflict and issues with internal and external customers
  • Builds and leverages relationships and provides advice internally within function and with global cross-functional teams
  • Bachelor’s Degree in Engineering, Chemistry or biological sciences
  • 8+ years in a technical role in quality engineering, manufacturing, analytical testing or engineering
  • Experience in medical device or pharmaceutical bio-pharmaceutical field
  • Education or training in cell culture and gene therapy a plus
3

Manager, Quality Systems Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of manager, quality systems. 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 manager, quality systems
  • Planning and conducting Internal Audits to monitor and improve/update the Management System
  • Schedule and conduct training for the location´s internal auditors
  • Participate in Management System Audits from Customers
  • Document Control and coordination
  • Responsible for developing fiscal expense budgets for the Quality Control/Quality Assurance responsibilities
  • Presents a monthly report of the quality control/assurance performance criteria and comments on significant deviations
  • Support the development of and assistance to lab technicians in troubleshooting equipment, test methods and any other functions as requested by staff members or as necessary, also ensure prompt notification of results
  • Ensure coordination of all outside laboratory testing needs and lab evaluation of quality on customer complaints, product studies, product history, competitor samples
  • Focused regular and direct quality reporting
  • Field Actions/Stop Shipment
Qualifications for manager, quality systems
  • Document management systems demonstrated knowledge in areas such as technical document creation, electronic and paper archival and retrieval
  • Ability to work independently with outside companies to complete complex tasks
  • Travel required, approximately 25-35%, both domestic and international
  • Requires approximately 5% travel, both domestic and international
  • Minimum 8+ years in Quality Assurance related product development and / or manufacturing
  • Master's degree in Engineering or similar fields
4

Manager, Quality Systems Job Description

Job Description Example
Our growing company is looking for a manager, quality systems. 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 manager, quality systems
  • Planning, integrating and implementing QMS strategies appropriate to the intended use and target market of products designed, manufactured and distributed Pharmaceutical systems business unit
  • Implement, maintain and support quality system processes, including support of organizations without certified quality management systems 3rd party manufacturers and suppliers
  • Provide training on QMS definitions and analysis and facilitating audit inputs and outputs for both internal and external regulatory inspections and supplier management
  • Implement and maintain internal data management and analysis mechanisms including quality performance communications to key internal stakeholders management of non-conformances, CAPA and change management
  • Ensure robust customer contact mechanisms including support of complaint reporting and Quality performance communications to key stakeholders
  • Provide resources and leadership to develop and implement submissions to regulatory authorities as determined by product commercialization and business strategy
  • Ensure regulatory strategies are in place for product shipping and distribution in line with BU policies
  • Manage and where appropriate implement policies, procedures and SOP’s to be used by QA staff
  • Ensure Quality and Regulatory records are maintained
  • Manage, mentor and assist the organization in meeting minimum regulatory requirements of distribution of new products in a time effective manner
Qualifications for manager, quality systems
  • Perform coaching sessions (Quality KPI, TQW, 7 Pillars, 7QB etc) to improve the Quality performance
  • Monitoring and follow up the progress of the Quality score card
  • Launch actions of scraps reduction to the sites out of target (STOP scrap project)
  • Build/lead/contribute to a Q task force team to turn around the critical sites (in series life / at launch phase)
  • Participate FES audits as country auditors (once a year)
  • AT&T remote trainings for Quality department packages
5

Manager, Quality Systems Job Description

Job Description Example
Our innovative and growing company is looking for a manager, quality systems. 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 manager, quality systems
  • Coordinate external audits (Corporate, External Regulators, FDA, and Notified Bodies) of the quality systems and other compliance activities
  • Interpret Existing or New Regulatory Requirements as they Relate to Company Products/Operations and Procedures, Testing, Records, to Ensure Ongoing Compliance
  • Conduct Internal Audits of QC Lab, Operations, Manufacturing, Labeling, , and External Suppliers
  • Support Quality IT function to ensure compliance needs are addressed, Quality team is appropriately represented and IT platforms are designed with quality in mind
  • In conjunction with other lead auditor, audit internal Del Monte facilities
  • Work as an administrator of Quality module in SAP
  • Work in partnership with R&D and QA in writing and reviewing technical specifications and ensure consistency and accuracy
  • Deliver, maintain and control issuance and maintenance of QA policies, procedures, formulas and specifications on QA team site
  • Responsible for assuring customer documentation requirements are completed and requests are analyzed, gaps are identified and addressed in a timely manner
  • Responsible for ensuring standard systems and processes are in place to support the Americas External Manufacturing organization
Qualifications for manager, quality systems
  • Bachelor degree in science, engineering, quality or other technical field
  • Auditor Certification, such as ASQ CQA, is preferred
  • MS Office Software, Minitab, Data Base Management and Basic Statistical Technics Expertise, Troubleshooting Methods, 8D’s
  • Undergraduate degree in food science or a related technical field is required
  • Minimum of 8 - 10 years of food industry quality plant/systems experience with demonstrated achievement in Quality leadership
  • PC skills, work processing, spreadsheets, project management

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