Contract Quality Systems Manager
 Advanced Clinical | |
 United States, Pennsylvania, Exton | |
 Jan 22, 2025 | |
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OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as a Contract Quality Systems Manager in Exton, PA. The Quality Systems Manager role is responsible for maintaining and improving Quality Systems for the Americas Region to ensure on-going compliance to applicable compendia, GMPs, and Regulatory guidance. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity. 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 Americas sites. * Contribute to the oversight of Quality Systems core responsibilities (track, report, adjust) by trending quality metrics for 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. EXPERIENCE & EDUCATION * Bachelors 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 CGMPs (EU, JP, US) * Detailed knowledge and application with electronic Quality Systems (i.e. TrackWise, Documentum) To be a best-fit your strengths must include: * 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, guidances 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 About Advanced Clinical Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com. Regarding your application Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately. | |