Senior Quality Manager Job Description
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 in 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
1
Senior Quality Manager Job Description
Job Description Example
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
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Senior Quality Manager Job Description
Job Description Example
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
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Senior Quality Manager Job Description
Job Description Example
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
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Senior Quality Manager Job Description
Job Description Example
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
5
Senior Quality Manager Job Description
Job Description Example
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