QUALITY SYSTEMS MANAGER

Company: Joul--
Location: Exton
Posted on: October 20, 2024

Job Description:

Job Title: Quality Systems Manager

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Location: Exton, PA
Type: Contract, Potential for extension or conversion to permanent

Responsibilities 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's sites.
Contribute to the oversight of Quality Systems core responsibilities (track, report, adjust) by trending quality metrics for company's 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.


Requirements
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



Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

Keywords: Joul--, Baltimore , QUALITY SYSTEMS MANAGER, Executive , Exton, Maryland