Contract Quality Systems Manager

Contract Quality Systems Manager

Location: Exton, PA

Duration: 12 Months

Job Description :

This position is responsible for maintaining and improving Quality Systems for the Company 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 Company 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 the Company Americas sites.

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

Required 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