Senior Manager, Quality Job Description
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:
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:
Desired experience for senior manager, quality includes:
Senior Manager, Quality Examples
Senior Manager, Quality Job Description
- 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
- 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
Senior Manager, Quality Job Description
- 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
- 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
Senior Manager, Quality Job Description
- 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
- 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
Senior Manager, Quality Job Description
- 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
- 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
Senior Manager, Quality Job Description
- 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
- 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