Quality Systems Manager
2 months ago
Quality Systems Manager
Location: Exton, PA
Duration: 12 Months
Job Description:
This position is responsible for maintaining and improving Quality Systems for the Company Americas Region to ensure on-going compliance to applicable compendia, GMP’s, and Regulatory guidance. The Quality Systems include quality risk management, documentation, global and local auditing, health authority inspection management, training, event management (deviations, complaints, CAPA), and change control (global and local). The role will interface with Quality System personnel in other Company sites.
The person in this position will serve as a subject matter expert (SME) for GMP and Data Integrity (DI) requirements. Must effectively work as a team with internal customers, peers, and management through effective oral and written communication. Must evaluate the compliance of records, documents, and Quality Systems to ensure that the site is operating per GMP and Data Integrity requirements.
Essential Functions:
- Collaborate and provide expert reviews to ensure records, documents, and Quality Systems meet GMP and DI requirements (promote quality, DI, and GMP awareness).
- Support external and internal audits for the Company Americas sites.
- Contribute to the oversight of Quality Systems core responsibilities (track, report, adjust) by trending quality metrics for Company Americas sites.
- Develop and manage processes that ensure the Exton site remains in compliance with global quality polices, regulatory requirements, and industry requirements, including periodic review and consolidation.
Other duties as assigned to facilitate ongoing Quality activities as required, including collaboration with other Quality groups.
Required Education and Experience:
- Bachelor’s degree (preferably in science related discipline) preferred
- 5 – 7 years of experience working with Quality Systems (Deviation, Change Control, CAPA, audit, etc.)
- Demonstrated proficiency and experience in working with Quality Systems IT applications
- Training within a regulated Pharmaceutical/biotech/medical device environment
- Understanding and application of CGMP’s (EU, JP, US)
- Detailed knowledge and application with electronic Quality Systems (i.e. TrackWise, Documentum)
Technical:
- Strong attention to detail as demonstrated through consistent quality of work
- Excellent written and verbal communication skills
- Computer proficiency in MS Word and Excel, Project and Visio required;
- Demonstrates process orientation—thinks through required steps and sequencing to ensure quality work output
- Strong project management skills are preferred
- Ability to anticipate potential problems and take proactive action to avoid/minimize impact
- Anticipates consequences of actions and how they impact other areas
- Ability to independently prioritize, plan and schedule workflow
- Timely follow up to ensure satisfactory resolution to issues
- Knowledge of CGMPs (relevant laws, guidance, directives and industry practice), and demonstrated ability to apply learnings appropriately
- Ability to interpret and apply GMPs, relevant laws, guidance’s and directives to extremely complex pharmaceutical situations
- Ability to work and coordinate activities across multiple functional groups with a sense of professionalism and urgency
- Ability to work collaboratively with internal and external team members and customers/contacts
- Self-motivated; able to work with minimal supervision. Exercises independent judgment in evaluating compliance.
- Ability to work in a controlled environment
- Good attendance and reliability
-
Quality Systems Manager
2 months ago
Exton, United States Zenith LifeScience Full timeQuality Systems ManagerLocation: Exton, PADuration: 12 MonthsJob Description:This position is responsible for maintaining and improving Quality Systems for the Company Americas Region to ensure on-going compliance to applicable compendia, GMP’s, and Regulatory guidance. The Quality Systems include quality risk management, documentation, global and local...
-
Contract Quality Systems Manager
2 months ago
Exton, United States Maxis Clinical Sciences Full timeJob DescriptionJob DescriptionDescription:This position is responsible for maintaining and improving Quality Systems to ensure on-going compliance to applicable compendia, GMP's, and Regulatory guidance. The Quality Systems include quality risk management, documentation, global and local auditing, health authority inspection management, training, event...
-
Contract Quality Systems Manager
2 months ago
Exton, United States Frink-Hamlett Legal Solutions Full timeGlobal pharmaceutical company seeks a Contract Quality Systems Manager who will provide Subject Matter Expertise (SME) for Good Manufacturing Practices (GMP) and Data Integrity (DI) requirements by maintaining and improving Quality Systems for the Americas Region. The temporary position is expected to last at least twelve months and the team is located in...
-
Contract Quality Systems Manager
2 months ago
Exton, United States Frink-Hamlett Legal Solutions Full timeGlobal pharmaceutical company seeks a Contract Quality Systems Manager who will provide Subject Matter Expertise (SME) for Good Manufacturing Practices (GMP) and Data Integrity (DI) requirements by maintaining and improving Quality Systems for the Americas Region. The temporary position is expected to last at least twelve months and the team is located in...
-
Contract Quality Systems Manager
2 months ago
Exton, United States Frink Hamlett Legal Solutions, Inc. Full timeJob DescriptionJob DescriptionGlobal pharmaceutical company seeks a Contract Quality Systems Manager who will provide subject matter expertise for Good Manufacturing Practices (GMP) and Data Integrity (DI) requirements by maintaining and improving Quality Systems for the Americas Region. The temporary position is expected to last at least twelve months and...
-
SAP Quality Management Functional Consultant
1 week ago
Exton, Pennsylvania, United States GSSR Inc Full timeJob OverviewKey Responsibilities:Demonstrate a comprehensive understanding of the overarching objectives and operational requirements, leveraging specialized knowledge to collaborate with Quality Assurance and Operations teams to articulate detailed User Stories for the Digital & Technology enablement of business objectives. This involves analyzing...
-
SAP Quality Management Functional Consultant
2 weeks ago
Exton, Pennsylvania, United States GSSR Inc Full timeJob OverviewKey Responsibilities:Demonstrate a comprehensive understanding of the overarching objectives and operational requirements, leveraging specialized knowledge to collaborate with Quality Assurance and Operations teams to outline detailed User Stories for the digital transformation of business needs. This involves analyzing challenges and proposing...
-
SAP Quality Management Functional Consultant
2 weeks ago
Exton, Pennsylvania, United States GSSR Inc Full timeJob OverviewKey Responsibilities:Demonstrate a comprehensive understanding of the overarching vision and operational requirements while leveraging specialized knowledge to collaborate with Quality Assurance and Operations teams to articulate detailed User Stories for Digital & Technology enablement of business objectives. This encompasses analyzing...
-
Director of Quality
3 weeks ago
Exton, United States Medix™ Full timeManagement & OrganizationUphold company's values of Integrity, Excellence, and Respect for People. Ensure employees are well-trained on ethics and compliance policies.Promote a safe and healthy work environment, actively engaging the Quality team in HSE programs and driving improvements toward site goals.Ensure staff qualifications and training, including...
-
Director of Quality
3 weeks ago
Exton, United States Medix™ Full timeManagement & OrganizationUphold company's values of Integrity, Excellence, and Respect for People. Ensure employees are well-trained on ethics and compliance policies.Promote a safe and healthy work environment, actively engaging the Quality team in HSE programs and driving improvements toward site goals.Ensure staff qualifications and training, including...
-
Quality Inspector
3 months ago
Exton, United States Innovative Solutions & Support Full timeOverview: Innovative Solutions Support (IS&S), located in Exton, PA is a diversified international avionics supplier to civil, military, business, and commercial markets. The scope of the IS&S Quality Management System is the design, development, production and repair of Integrated Cockpit Display and Navigation Systems, Air Data Systems, Fuel Quantity...
-
Quality Inspector
3 months ago
Exton, United States Innovative Solutions and Support Full timeJob DescriptionJob DescriptionOverview: Innovative Solutions Support (IS&S), located in Exton, PA is a diversified international avionics supplier to civil, military, business, and commercial markets. The scope of the IS&S Quality Management System is the design, development, production and repair of Integrated Cockpit Display and Navigation Systems, Air...
-
Quality Assurance Specialist
2 days ago
Exton, Pennsylvania, United States Innovative Solutions and Support Full timeJob DescriptionOverview:Innovative Solutions and Support (IS&S) is a leading international supplier of avionics systems to various markets. Our Quality Management System encompasses the design, development, production, and repair of advanced cockpit display and navigation systems, air data systems, fuel quantity measurement systems, multifunction engine and...
-
Quality Assurance Specialist
2 weeks ago
Exton, Pennsylvania, United States Path Engineering Full timePosition Overview As a Quality Assurance Specialist, you will be responsible for conducting both in-process and final inspections to ensure that products meet established quality standards. Your role will involve maintaining the calibration of testing instruments and tools, as well as collaborating closely with Quality Assurance Management to align with...
-
Quality Assurance Specialist
5 days ago
Exton, Pennsylvania, United States The Food Source International, Inc. Full timeJob SummaryWe are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team at The Food Source International, Inc. This is an exciting opportunity to work in a dynamic food manufacturing environment where you will be responsible for ensuring the quality and safety of our products.Key ResponsibilitiesConduct routine quality...
-
Quality Inspector
4 weeks ago
Exton, United States AS Manufacturing Services Full timeJob DescriptionJob DescriptionJob Title: Quality InspectorLocation: Exton, PA (on-site position)Shift: 2nd shift, Monday-Friday 3pm-11:30pmPay: $20-$23/hour (plus $1.50/hr shift differential)Perks: Full time position with benefits and room for growth within the company!Responsibilities:Inspect incoming materials and perform in-process and final inspections,...
-
Quality Inspector
4 weeks ago
Exton, United States AS Manufacturing Services Full timeJob Title: Quality Inspector Location: Exton, PA (on-site position) Shift: 2nd shift, Monday-Friday 3pm-11:30pm Pay: $20-$23/hour (plus $1.50/hr shift differential) Perks: Full time position with benefits and room for growth within the company! Responsibilities: Inspect incoming materials and perform in-process and final inspections, as required Maintain...
-
Quality Inspector
1 month ago
Exton, United States Active Staffing Services Full timeJob DescriptionJob DescriptionA large client Avionics supplier in Exton, PA is actively searching for a Quality Inspector to join their team!!! This direct hire position is set to start immediately and the hours are for the second shift; 3pm to 11:30pm.Duties & Responsibilities:Perform inspection of all incoming material; perform in-process and final...
-
Project manager
7 days ago
Exton, United States Sunrise Systems, Inc. Full timeSunrise System Inc. is currently looking for Project manager -Global Equity Compensation at Exton, PA OR Lexington, MA, Hybrid with one of our top pharma clientJob Title: Project manager -Global equity compensationLocation: Exton, PA OR Lexington, MA, HybridDuration: 12 months (Possible contract to hire role for right fit)Position Type: Hourly contract...
-
Quality Inspector
2 weeks ago
Exton, United States AS Manufacturing Services Full timeJob Title: Quality Inspector Location: Exton, PA (on-site position) Shift: 2nd shift, Monday-Friday 3pm-11:30pm Pay: $20-$23/hour (plus $1.50/hr shift differential) Perks: Full time position with benefits and room for growth within the company! Responsibilities: Inspect incoming materials and perform in-process and final inspections, as required Maintain...