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Quality Systems Manager

1 month ago

Exton, United States Maxis Clinical Sciences Full time
Job DescriptionJob Description

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 management (deviations, complaints, CAPA), and change control (global and local). The role will interface with Quality System personnel in other client 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 client sites.
• Contribute to the oversight of Quality Systems core responsibilities (track, report, adjust) by trending quality metrics for client 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.

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

Company DescriptionMaxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12+ years of average experience.

Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.Company DescriptionMaxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12+ years of average experience.\r
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Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.