Global pharmaceutical company seeks a Contract Quality Systems Manager who will provide subject matter expertise for Good Manufacturing Practices (GMP) and Data Integrity (DI) requirements by maintaining and improving Quality Systems for the Americas Region. The temporary position is expected to last at least twelve months and the team is located in Exton, PA. The hourly pay range is between $55 - $60 (with potential wiggle room), depending upon experience. 

Primary Duties:

The Contract Quality Systems Manager will 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 Company sites.

You 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 DI requirements. Additional duties include but are not limited to:

• 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 Americas sites

• Contribute to the oversight of Quality Systems core responsibilities (track, report, adjust) by trending quality metrics for Company's 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:

• 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)

• 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 with the ability to work with minimal supervision, exercises independent judgment in evaluating compliance, and thrives in a controled environment

• Good attendance and reliability

Frink-Hamlett Legal Solutions is an equal employment opportunity employer and all applicants will receive consideration for employment without unlawful discrimination based on race, color, creed, national origin, sex, age, disability, marital status, sexual orientation or citizenship status.