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Quality Systems Manager

Lancesoft

Exton, PA

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JOB DETAILS
SALARY
$139
LOCATION
Exton, PA
POSTED
30+ days ago
Job Responsibilities:
This position is responsible for maintaining and improving Quality Systems for 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 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 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.

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)
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

About the Company

L

Lancesoft

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc). 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2000
WEBSITE
http://www.lancesoft.com/

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