Total Quality Management Senior Manager jobs in Massachusetts
Total Quality Management Senior Manager develops and implements an organization's total quality management strategy with policies, programs, and initiatives. Leads cross functional teams to study and develop effective tools, methods, and systems to ensure that the products and services are of the highest quality. Being a Total Quality Management Senior Manager creates standards used to measure quality results and to drive continuous improvements. Utilizes Six Sigma/Lean methodologies. Additionally, Total Quality Management Senior Manager requires a bachelor's degree in area of specialty. Typically reports to top management. The Total Quality Management Senior Manager typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Total Quality Management Senior Manager typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
Recently Added Total Quality Management Senior Manager jobs
Manager, Quality Management & Compliance
- PharmaLex
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Boston, MA
FULL_TIME
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PharmaLex is one of the largest worldwide providers of consulting services in the following focus areas: Quality Management & Compliance; Development Consulting & Scientific Affairs; Regulatory Affairs; and Pharmacovigilance, Epidemiology and Risk Management. Through our US, European and Asia-Pacific offices, our trusted consultants provide specialized, regulated services to pharma, biotech, and MedTech industries, helping them successfully meet the regulatory compliance challenges during the journey of bringing their products to market and helping them to maintain and sustain Quality Compliance level for products, processes and service providers, according to applicable regulations . PharmaLex has extensive regulatory and scientific experience in all therapeutic areas and product formulations.
PharmaLex is proud to be an equal opportunity employer. We respect and seek to empower each individual, and support the diverse cultures, perspectives, skills, and experiences within our workforce. We believe that diversity and inclusion among our teammates is critical to our success as a global company and we seek to recruit, develop and retain the most talented people from a diverse candidate pool.
As a Key Contributor You Will consistently deliver high-quality services to our clients in the QMC areas (including Auditing, Quality Systems and Compliance, and expert Technical Consulting) by managing, implementing and/or successfully executing projects.
You will provide Quality Compliance support as for a variety of projects. The individual will be responsible for developing, improving and advising on phase appropriate Quality processes and procedures in compliance with all current GMP and applicable global regulations and guidance. This role will also aid in assessing compliance level with current GMP requirements by performing audits, gap assessments and as requested aiding in remediation efforts for any gaps.
Key Responsibilities And Activities- Execute Vendor, CMO, Service provider audits on behalf of clients as needed in the area of expertise, write audit reports and coordinate with client on acceptable responses.
- Assist clients with development of QMS and Quality Systems SOPs as needed based on the clinical or commercial phase of the product, example SOPs include: document control, batch record review and release, production oversight, investigations, CAPA, change control, complaints, recall, QMR, QRM, Training, vendor management, etc.
- Assist clients with ensuring robust investigations executed and CAPA/remediations assigned.
- As needed provide batch review and product release services for clients.
- Provide technical consulting as needed for client GXP concerns and formalize responses in writing within 1 week period.
- Assist with compliance gap assessments as needed including Annex 1 reviews and propose remediations for gaps found.
- Aid in assessing qualifications of additional consulting associates based on project type needed.
- Participate in at least one Business Development event per year, including presentations, workshops, podcasts, creation of published content
- Assist with creation of standardized tools to assist in development of lean processes.
- Engage with clients on scoping calls to aid with defining project needs.
- Support assigned work activities for specific QA projects or objectives as required
- BA/BS in a Life Science or Chemistry field of study. Microbiology experience is a plus.
- Minimum of 7 years of experience within a Quality Assurance/Quality Operations role for Aseptic Production of sterile products within the Pharma Industry (e.g. Pharmaceuticals, Biotechnology, Medical Devices, Cell & Gene Therapy), within a global pharma company.
- 3 years of experience in a Quality Assurance/Quality Operations decision-making role in Pharma industry, preferred.
- Knowledgeable of FDA, EMA, ICH, and other industry guidelines from major regulatory bodies as they relate to cGXP operations, and proven ability to relate these to current operations. Familiarity with Annex 1 is a plus.
- Familiarity with the latest industry practices from benchmarking groups such as ISPE and PDA.
- Demonstrated experience writing SOPs, Policies, and performing the entire Batch Record Review and Product Release process
- Experience auditing (internal and external), writing audit reports and designing remediation plans that are fit for purpose related to business and resources.
- Hands-on experience with Quality Risk Management, execution of Risk Assessments and integrated Quality Systems
- Experience working with third parties and effectively using strong interpersonal skills, and negotiation skills to influence and accomplish work
- Experience with software related to Quality Management Systems (e.g. Veeva, Master Control, Trackwise, Documentum, ComplianceWire, etc.)
- The desire and ability to work in a fast-paced, start-up environment
- Strong collaboration/teamwork skills, organizational skills, project management and attention to detail
- Excellent written and verbal communication skills including presentations to cross-functional meetings, senior management and to key external stakeholders
- Ability and skill to perform the detailed job requirements noted above competently, safely, and proficiently
- Team members’ feedback
- Client Satisfaction
- Successful delivery of client programs – on time and on budget, or appropriate agreed deviations with client
- Financial performance of service area is within acceptable, agreed KPI’s
- Utilization
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Senior Project Manager
- National Institute for Children's Health Quality (NICHQ)
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Boston, MA
FULL_TIME
- Position Responsibilities In partnership with Project Director, manage project team and deliverables includingdaily operations, project workplan, contracts, invoice, project spending and technical req...
- 12 Days Ago
Senior Manager of Quality
- MKS Instruments, Inc.
-
Wilmington, MA
FULL_TIME
- A Day in Your Life at MKS: As the Senior Manager of Quality for our Plasma & Reactive Gas business unit you will use your exceptional quality assurance experience to develop and implement quality stra...
- 3 Days Ago
Senior Quality Manager 3
- HII
-
Pocasset, MA
FULL_TIME
- Requisition Number: 19130Required Travel: 0 - 10%Employment Type: Full Time/Salaried/ExemptSecurity Clearance: Ability to ObtainLevel of Experience: ManagementThis opportunity resides with Unmanned Sy...
- 4 Days Ago
Senior Manager of Quality
- MKS Instruments
-
Wilmington, MA
FULL_TIME
- A Day in Your Life at MKS:As the Senior Manager of Quality for our Plasma & Reactive Gas business unit you will use your exceptional quality assurance experience to develop and implement quality strat...
- 4 Days Ago
Senior Manager, Quality Operations
- Keros Therapeutics
-
Lexington, MA
FULL_TIME
- Keros Therapeutics is a public, clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from hematological and ...
- 5 Days Ago
Total Quality Management Senior Manager jobs at Popular Companies
Plant Quality Assurance Manager
- Unilock
-
Brewster, NY
- Reporting to the Director of Quality Assurance, the Quality Assurance Manager is primarily responsible for ensuring that...
- 6/11/2024 12:00:00 AM
Production Supervisor
- Aegis Worldwide
-
Sycamore, IL
- Job Description Job Description First Shift - Flexible start time! Union Environment Aegis Worldwide is seeking a Produc...
- 6/11/2024 12:00:00 AM
QA Tech, Fort Smith, Night Shift
- Simmons Foods
-
Fort Smith, AR
- PURPOSE OF THE POSITION Tests and conducts routine and non-routine analysis of raw materials, in-process, and finished p...
- 6/11/2024 12:00:00 AM
Quality Inspector I
- E-Z-Go
-
Augusta, GA
- Textron Specialized Vehicles Inc. is a leading global manufacturer of golf cars, utility and personal transportation veh...
- 6/11/2024 12:00:00 AM
Quality Inspector
- Textron
-
Cartersville, GA
- Textron Specialized Vehicles Inc. is a leading global manufacturer of golf cars, utility and personal transportation veh...
- 6/11/2024 12:00:00 AM
Assembler I - 1st
- Knape & Vogt
-
Petaluma, CA
- **Description** *Position at Workite* ****Job Description Summary**** The Assembler I position involves the safe and cor...
- 6/10/2024 12:00:00 AM
Post Pasteurizer Operator - HPP
- Hiring Now!
-
New Castle, IN
- Hiring Company: Boar's Head Provisions Co., Inc.Overview:Job Description:Responsibilities:Responsible for performing tas...
- 6/8/2024 12:00:00 AM
Quality Assurance Manager
- United Employment Group, Inc.
-
Brewster, NY
- Description: Reporting to the Director of Quality Assurance, the Quality Assurance Manager is primarily responsible for ...
- 6/7/2024 12:00:00 AM
About Massachusetts
Massachusetts is the 7th-smallest state in the United States. It is located in the New England region of the northeastern United States and has an area of 10,555 square miles (27,340 km2), 25.7% of which is water. Several large bays distinctly shape its coast. Boston is the largest city, at the inmost point of Massachusetts Bay, and the mouth of the Charles River.
Despite its small size, Massachusetts features numerous topographically distinctive regions. The large coastal plain of the Atlantic Ocean in the eastern section of the state contains Greater Boston, along with most of the state's po...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Total Quality Management Senior Manager jobs
$204,540 to $222,668
Most Popular Cities in Massachusetts for Total Quality Management Senior Manager Jobs
What does a Total Quality Management Senior Manager do?
Total Quality Management Senior Manager in Daytona Beach, FL
With that in mind, management consultant William Deming developed an entirely new set of methods with which to address quality.
January 06, 2020
Total Quality Management Senior Manager in Jamestown, NY
After reading you will understand the basics of this powerful quality management tool.
December 28, 2019
Total Quality Management Senior Manager in New Orleans, LA
Where it was not possible to inspect every item, a sample was tested for quality.
December 31, 2019