Job Description

The Opportunity:

Global pharmaceutical company in Exton, PA seeks a Contract Quality Systems Manager to join their team. This is a long-term, temporary position, Monday - Friday, 40 hours per week. The position is hybrid in Exton, PA and the hourly rate is $70 plus benefits.

Primary Duties:

The Contract Quality Systems Manager responsible for maintaining and improving Quality Systems for the company's region to ensure on-going compliance with 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 Contract Quality Systems Manager will interface with Quality System personnel in other sites. The Contract Quality Systems Manager 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 DI requirements. Additional duties include the following:

• 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 the 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:

• 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;
• ​Strong project management skills are preferred
• 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 work in a controlled environment

The Partnership – Benefits:

• ABA - MEC Medical Benefit
• PEP 401kPaid
• Time Off
• Employee Assistance Program (EAP)
• Working Advantage {discounts)
• Financial Wellness Program (FinFit)

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

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