Job Descriptions

Senior Quality Manager

Job Description

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Senior Quality Manager

Job Description

4.5

191

votes
for Senior Quality Manager

Senior quality manager
provides guidelines to support implementation of quality agreement and key QMS requirements, review supplier quality improvement plan for compliance with Quality Agreement and key quality systems such as Change Control Management, contamination control systems, deviation control systems, etc.

Senior Quality Manager

Duties & Responsibilities

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

Sample responsibilities for this position include:

Continuous improvement programs

Drive problem solving for key packaging quality issues using 8D/Drill Deep & Wide

Develop & execute quality tools, processes, projects with influencing engineering & manufacturing plants quality teams to improve product quality

Deliver significant improvements to the bottom line through Product Damage improvement

Plans and conducts document, internal and external GCP audits of clinical research activities to assess compliance with FDA, ICH GCP, and local regulations, with protocol and company SOPs

Audits and evaluates service providers

Evaluates corrective and preventative action responses to audit findings for adequacy and timeliness and manages the closeout of all corrective and preventative actions

Develops audit plans for Acorda clinical studies

Plans and conducts domestic and international inspections

Applies departmental SOPs and participates in the development of departmental SOPs, as appropriate

Senior Quality Manager

Qualifications

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

Licensing or Certifications for

Senior Quality Manager

List any licenses or certifications required by the position:
ISO, 9001, ASQ, API, PMP, HACCP, ITIL, NRA, NAVFAC, USACE

Education for

Senior Quality Manager

Typically a job would require a certain level of education.

Employers hiring for the senior quality manager job most commonly would prefer for their future employee to have a relevant degree such as

Bachelor’s and Master’s Degree

Engineering, Science, Technical, Education, Business, Management, Chemistry, Computer Science, Manufacturing, Healthcare

Skills for

Senior Quality Manager

Desired skills for
senior quality manager
include:

MS Office and product lifecycle management systems

Army Corps of Engineers

Continuous improvement

IPC-610 and its application to process control

ISO 9000

Kaizen

Lean

Malcolm Baldridge

Mortenson’s Quality System

Quality systems:

Desired experience for
senior quality manager
includes:

Communicates effectively and constructively with all teams to ensure alignment to direction and goals

Effectively manages leadership communication with internal external relationships (vendors)

Knowledge of data quality management tools

Bachelor’s degree from a four year college or university in Engineering or related field

Certified Quality Auditor preferred

Six Sigma Black or Green

Senior Quality Manager

Examples

Senior Quality Manager Job Description

Job Description Example

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Microsoft Word (.docx)

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Our company is growing rapidly and is hiring for a senior quality manager. To join our growing team, please review the list of responsibilities and qualifications.

Responsibilities for senior quality manager

Responsible for training and mentoring associates in Quality department
Quality performance measurement and analysis
Administration of policies and procedures, quality records, and external certifications
Manages and meets customers’ expectations for quality through the management of the CQE team
Coordinating the performance of audits to assess compliance to quality and regulatory requirements both internally and at Contract Manufacturer locations
Coordinating and hosting all customer, regulatory and registrar audits on behalf of the site and assume responsibility for ensuring corrective actions meet customer and company expectations
Designing, developing or facilitating the delivery of related training both internally and at the Contract Manufacturer locations in response to site needs relative to quality and regulatory requirements
Providing guidance/arbitration and required decisions in interpretation of quality and regulatory requirements to support business objectives
Acting as Site Quality Leader and Management Representative in accordance with AS9100
Assessing skills and talent and continuously developing team capability in response to business, customer and regulatory needs.

Qualifications for senior quality manager

Strong knowledge of GCPs, FDA regulations and ICH guidelines required
Master’s degree in life sciences or related field preferred
Minimum of seven years progressive experience in the regulatory compliance environment
Minimum of five years Quality auditing experience in the Biotechnology or Pharmaceutical industries required
Strong knowledge of CGMP concepts
Must be able to interpret and apply GMP regulations and guidances with supervision

Senior Quality Manager Job Description

Job Description Example

Download

Microsoft Word (.docx)

.DOCX
PDF Document (.pdf)

.PDF
Image File (.png)

.PNG

Our company is growing rapidly and is searching for experienced candidates for the position of senior quality manager. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.

Responsibilities for senior quality manager

This position may also require periodic business travel car/plane less than 10%)
Evaluate effectiveness of the CMO’s Quality Unit and systems and influence External Suppliers promoting robust systems under self-sufficient organizations
Ensure that investigations associated with assigned Contracts Manufacturers are properly carried out, resulting in sustainable CAPA, documented, evaluated, and closed as efficiently as possible, and in respect with the procedure
Support new product introductions from an operational perspective
Be able to share expertise and functional knowledge to carry out day to day activities effectively on the relevant manufacturing processes
In absence of Quality Group/Cluster lead (where applicable) support and advise Quality managers on quality including, but not limited to, quality agreement negotiation and implementation
Perform risk assessments for products and setup control plans to prevent/resolve issues
Continuously refine test methods and protocols with 3rd party agencies
Monitor 3rd party test agencies’ performance
Provide full visibility to internal stakeholders

Qualifications for senior quality manager

Knowledge in qualification, validation processes
Extensive knowledge of FDA, EMA and ICH GMP requirements
Ability to multi-tasks and adjust priorities, as necessary
Strong knowledge of FDA regulations and ICH guidelines related to GPvP is required
Must be able to interpret and apply GPvP regulations and guidances, including 21CFR part 11 requirements
Maintains professional expertise and knowledge of local and international regulations related to Quality and GPvP

Senior Quality Manager Job Description

Job Description Example

Download

Microsoft Word (.docx)

.DOCX
PDF Document (.pdf)

.PDF
Image File (.png)

.PNG

Our company is hiring for a senior quality manager. 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 senior quality manager

Interface with customers to learn and understand requirements describe proposed solutions
Work closely with other MBD manufacturing sites around the world in order to ensure dissemination of information and best practices encouraging and promoting inter-site communications
Manages the receipt, categorization and reconciliation of complaints through the designated software system
Ensure samples are requested in support of complaint investigations, when required to thoroughly investigate the complaint
Ensure comprehensive deviation root cause analysis and quality impact assessment
Ensure accurate reporting of site metrics related to complaints and field alert reports
Engage in new process development and evaluate process changes in order to analyze risks and ensure product and service quality
Provide support for customer responses, surveys, regarding requirements
Facilitate Corrective Action and Preventive Action (CAPA) Process
Drive and Track Quality DNA – training, testing & certification, lead any other analytics and productivity initiatives that come up

Qualifications for senior quality manager

The job holder is expected to support the Head of Sales Quality and Operations Support to oversee and supervise implementation of RBWM Sales Quality Standards and the introduction of Sales Activity Management processes
Ability to review documentation, processes and procedures as they relate to pharmacovigilance activities, to identify issues/problem areas, assess compliance and communicates findings to the appropriate team(s) and management
Ensure availability of resources for establishing and maintaining effective methods for managing projects ensuring deliverables are completed on schedule
Ensure methods are in place and resources available for compliance risks assessments performed at program/project initiation and for mitigating risks before completion of projects reviewing project/program status at checkpoints
Develop and train staff to ensure qualified and competent Quality & Regulatory resources are available to represent Customer Services Quality & Regulatory in programs and projects including cross-functional & cross organizational teams
Support regulatory and internal audits

Senior Quality Manager Job Description

Job Description Example

Download

Microsoft Word (.docx)

.DOCX
PDF Document (.pdf)

.PDF
Image File (.png)

.PNG

Our company is hiring for a senior quality manager. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.

Responsibilities for senior quality manager

Ensure continuous improvement through the Practical Process Improvement (PPI) Program
Set facility level Quality operations goals and objectives for customer focused quality initiatives
Manage Q-improvement and integration plans
Manage and coach a growing QA/ QC team
Collaborate with other functions and departments on QA related aspects
Ensure Quality & Regulatory aspects are adequately covered in the selection, control and monitoring of suppliers
Compliance, effectiveness and efficiency of the QMS and operations
Provides leadership for a QA team by ensuring individuals have the appropriate education, training and experience to fulfill their role
Ensures resources are available to appropriately execute QA processes, mitigate compliance risks and provide quality oversight of the sites operations
Designs and delivers appropriate training material as required

Qualifications for senior quality manager

Extensive knowledge of global medical device regulations, requirements, and standards
Expert knowledge of quality system standards and regulations
Job location in Xilinx’ Head Office in San Jose, CA, USA
Travel required (~10% Local (NA), ~15% International)
Must have good understanding of the engineering processes, quality management processes and regulatory standards
Lead Quality Projects for the business, individually complete 2-3 high impact projects per year per corporate guidelines

Senior Quality Manager Job Description

Job Description Example

Download

Microsoft Word (.docx)

.DOCX
PDF Document (.pdf)

.PDF
Image File (.png)

.PNG

Our innovative and growing company is searching for experienced candidates for the position of senior quality manager. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.

Responsibilities for senior quality manager

Drive QA strategy and improvements that focus on processes that have a significant financial customer impact
Develop necessary QA requirements as we move into a workflow system
Enhance and monitor scoring, providing an accurate reflection of claims performance
Lead and motivate the QA Team
Develop metrics/scorecards to drive productivity and performance within the team
Partner with risk and controllership, validating that critical to quality controls meet the required risk mitigates necessary, including SOX and SOC1
Provide insights to leadership on areas of concern
Drive consistency and accountability for error corrections across the department
Work with internal and external auditors to provide assurance of quality controls
Demonstrable experience in making sound business decisions using risk management and quality protocols

Qualifications for senior quality manager

Follow up with global/regional process owners on processes updates and implement at reposible sites on time
Participation in local, regional and global logistics re-engineering projects
Knowledge and working application of FDA
Provide leadership during stressful production demands
Supports employee and team performance
Supports and ensures effective employee relations