Senior Manager, Quality Job Description
Senior manager, quality
provides the direction, coordination, education and tools needed to be compliant with FDA regulations (21 CFR, 820,807,803 as well as ISO 13485:2016).
Senior Manager, Quality Duties & Responsibilities
To write an effective senior manager, quality job description, begin by listing detailed duties, responsibilities and expectations. We have included senior manager, quality job description templates that you can modify and use.
Sample responsibilities for this position include:
Developing, implementing and maintaining policies and procedures to comply with applicable Civil Aviation and Military requirements (TCCA, FAA, EASA, CAAC, DND, DCMA ..) International quality systems standards and aerospace standards in support of business objectives
Leads cross functional teams to improve processes and procedures
Corrective and preventative action processes
Participating as required in regulatory and government agency committees involved in developing new or revised standards
Reviews internal SOPs and external SOPs
Maintains Quality documentation files, databases and logs
Participates on Process Improvement teams
Assists with GCP internal training internally and where required external of investigators and service providers
Acts as a key point of contact for staff, providing information and expert guidance on regulations and procedures related to GxP and Quality to Acorda associates
Ensures compliance with all of Acorda policies and procedures including safety rules and regulations
Senior Manager, Quality Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Senior Manager, Quality
List any licenses or certifications required by the position: ISO, 9001, ASQ, API, PMP, HACCP, ITIL, NRA, NAVFAC, USACE
Education for Senior Manager, Quality
Typically a job would require a certain level of education.
Employers hiring for the senior manager, quality 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 Manager, Quality
Desired skills for senior manager, quality include:
ISO 13485
FDA
Applicable local
Federal/national statutes and guidelines
Standards
State/province
CGMP regulations
Processes
USP
Equipment
Desired experience for senior manager, quality includes:
Whilst the job holder will report to the Head of the function it is expected that the job holder will have a good deal of autonomy in determining appropriate strategies which are consistent with the overall policies developed by the function
Outside the routine branch reviews some of the activities encountered by the incumbent will be non-repetitive in nature
Sound knowledge and understanding of RBWM business and the market it operates in
Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities
Investigate to truly discern meanings and intentions to ensure that parties share the same understanding
Advanced skills in Microsoft Word, Excel, Outlook, PowerPoint and Project
Senior Manager, Quality Examples
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Senior Manager, Quality Job Description
Job Description Example
Our growing company is looking to fill the role of senior manager, quality. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for senior manager, quality
- Define criteria and processes to apply and track detailed set of metrics for implementing quality and safety process requirements
- You define, implement and improve continuously quality systems and processes
- Providing leadership to the team of Customer Quality Engineers, AS9100 /Special Process Auditors/Quality Engineers maintaining oversight of all quality related aspects related to Customers, Contract Manufacturers and external suppliers
- Establishing schedules and plans to ensure that resources are available for established operational assignments
- Driving performance management, providing regular feedback and coaching for each team member
- Managing performance of direct reports including performance evaluations and development plans, salary increases, and promotions
- Interpreting and applying organization policies, monitoring and resolving employee problem situations
- Managing indirect reports through influence and coaching
- Coaching , championing, and leading multi-discipline and/or cross-functional teams as required
- Develop and provide insight on automotive autonomous vehicle market and new quality requirement needs, challenges, and segmentation, related strategic input into the automotive business development plan
Qualifications for senior manager, quality
- Canada is among the priority markets that Group focus on and therefore the job has become high profile
- Minimum significant years working in a regulated medical device or pharmaceutical industry
- Minimum some years of supervisory/management or project leadership experience
- Bachelors Degree or equivalent experience in a technical/scientific field, engineering, chemistry, biology, or mathematics
- Minimum of five years auditing experience in the Biotechnology or Pharmaceutical industries required
- Prior experience with the Biotechnology or Pharmaceutical industries required
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Senior Manager, Quality Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of senior manager, quality. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for senior manager, quality
- Coordinate all activities relative to obtaining desired certifications for operations, , ISO 13485, ISO 9001 and ISO 14001 registration in the absence of the Management Representative
- Lead the team in managing workflow using Agile processes and tools in improving the general engineering process
- Led the plant-wide effort to reduce scrap and rework costs, and to identify root causes and solutions for quality defects
- Provide leadership and coaching for the calibration lab and receiving inspection team
- Work seamlessly with the QA/RA team to ensure the optimal performance of the site in meeting our customer, business and regulatory commitments
- Ensure the meaningful and timely resolution of CAPA’s, PSR’s, and PQR’s
- Work with design, manufacturing, and NPI teams to drive changes that will reduce quality issues and result in higher long-term reliability
- Identifying and solving product, system and process problems
- Support lean manufacturing and continuous improvement efforts, including in-sourcing projects, waste reduction efforts, inventory reduction efforts
- Manages objectives of Quality Initiatives such as the analysis of returned/defective products
Qualifications for senior manager, quality
- Minimum of seven years experience in the regulatory compliance environment
- Strong knowledge of drug safety computer systems required
- Using previous skills and knowledge provide technology leadership in areas such as SQL queries, UNIX, Web Services and Web App testing
- Willingness to travel to various supplier locations or Takeda sites, including overnight trips
- Establish and maintain relationships and networks with key Business Group and Customer Service leaders forming effective relationships and ways of working which position Quality & Regulatory as an essential and valued business partner
- Working closely with Business Group, Market and Customer Service representatives and Subject Matter Experts, identify service related improvement opportunities, assess risks, prioritize issues, establish solution strategies and manage change and improvement projects
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Senior Manager, Quality Job Description
Job Description Example
Our company is searching for experienced candidates for the position of senior manager, quality. 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 senior manager, quality
- Develop, manage, and enforce purchasing controls procedures aligned with FDA, ISO, and other relevant regulatory requirements
- Establish clear processes & procedures for all EES suppliers
- Ensure all processes and procedures are properly documented, managed, implemented, and monitored
- Lead manufacturing and supplier quality initiatives to ensure Smiths quality standards are consistently achieved and maintained
- Develop world class, common systems for completely integrating Quality Management Systems with Operational processes and the Smiths Operating System
- Participate in the review of all design, manufacturing, purchasing, and test documentation to assure conformance to quality standards
- Assist in the review of validation of test methods, procedures, equipment, and facility
- The role provides an opportunity to lead initiatives providing exposure to senior stakeholders – internal and external
- Managing, implementing & monitoring supplier development at external sites for manufacture of finished devices, sub-assemblies & components, and for those suppliers that provide other goods and/or services that impact our quality system
- Managing design, implementing & monitoring of quality systems at external sites for manufacture of finished devices, sub-assemblies & components, and for those suppliers that provide other goods and/or services that impact our quality system
Qualifications for senior manager, quality
- Ensure Customer Service Quality Management System documents are established (according to LEAN principles) and maintained as needed to ensure effectiveness and compliance
- Ability to take firm positions on technical issues when necessary to ensure compliance is maintained
- Knowledge of Automotive electronics and application market trends
- Direct experience with active functional safety (ISO26262), Autonomous Vehicle applications and overall automotive system architectures required
- Ability to multi-task, detailed oriented while meeting tight deadlines under pressure
- Must be a strong team player and very self-motivated individual
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Senior Manager, Quality Job Description
Job Description Example
Our company is growing rapidly and is hiring for a senior manager, quality. 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 manager, quality
- Assures compliance to in-house and/or external specifications and standards such as ISO regulations
- Define quality parameters and processes for vendor manufacturing and packaging facility
- Setup and lead team that will audit and monitor product quality & vendor processes
- Hosts client and regulatory inspections
- Acts as QA Management representative during strategic client interactions
- Establishes strategic Quality plans and objectives in support of business objectives
- Management of PPAP to coordinate activity to completion with EMEIA stakeholders / resources
- Management of and attainment of ISO9000 audits BSI, Customer audits, Kitemark audit support
- Determine, organize and apply necessary resources to meet identified Quality Requirements and ensure Corporate, Regulatory, Quality requirements are met
- Manage a team of 6 quality specialists, across 5 sites globally
Qualifications for senior manager, quality
- Identifying areas of significant Customer Business Impact and improvement opportunities therein and provide strategic direction & thought leadership
- Focus on Process improvement and cost reduction for clients to deliver tangible benefits
- Post-Graduation in Quantitative sciences or MBA
- Lean six sigma BB certification (Preferably)
- Logistics quality covers activities including warehousing, transportation, and call center service of Shanghai and Hongkong
- Responsibility for the logistics controlling documents to meet specified deliverables, performance and business objectives
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Senior Manager, Quality Job Description
Job Description Example
Our company is growing rapidly and is looking for a senior manager, quality. 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 manager, quality
- Promote alignment across the broader operations organization, proactively searching for opportunities to leverage best practices across functional lines
- Assurance of safety, identity, purity of product(s) within each business unit
- Analyzes and organizes complex qualitative and quantitative clinical, financial and administrative data from multiple sources, and synthesizes results into meaningful reports and presentations on a regular basis for key stakeholder groups
- Assess, organize and develop an implementation plan for Institute data and programmatic requirements that are needed to meet federal and state mandates for QI reporting pursuant to PCHQR, Meaningful Use and MIPS program, MassHEALTH, Mass DPH, CHIA and other programs
- Provides project management of quality and performance measurement initiatives under direction of the Vice President Quality and Patient Safety
- Oversee quality data infrastructure related to the responsibilities above
- Interacts frequently with senior leaders, staff, and other clinical staff to facilitate discussions with these stakeholders regarding existing data, reports, and analyses and assesses unmet needs and potential system enhancements
- Serves as point of contact and subject matter expert to facilities that do not have full-time, on-site Quality Manager
- Interacts directly with contracted customer's quality resources to mutually support quality and regulatory requirements
- Performs other duties as assigned by the Managing Director to support Healthcare Logistics business
Qualifications for senior manager, quality
- Bachelor’s Degree in Engineering, Chemistry or biological sciences or equivalent
- Bachelor, diploma, masters`s or doctoral degree in Pharmaceutics, Chemistry, Biotechnology, or Biology
- More than 5 years' practical working experience in an international GMP regulated environment (e
- Minimum 4 years' leadership experience (line function or matrix)
- Prior experience with antibody drug conjugates and/or managing computer system validation projects would be a plus
- Establish team metrics and goals for safety, quality, cost and delivery