Job Description
Job Title : Quality Systems Manager
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.
Job Tags
Permanent employment, Contract work,