Contract Quality Systems Manager

---

Job description

At-a-Glance:

Are you ready to build your career by joining a global pharmaceutical company? If so, our client is hiring a Contract Quality Systems Manager!

What You'll Do:

Responsible for maintaining and improving Quality Systems for Americas Region to ensure on-going compliance to applicable compendia, GMP's, and Regulatory guidance.

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).

Interface with Quality System personnel on other sites.

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 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 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.

What You'll Bring:

Bachelor's degree (preferably in science related discipline) preferred.

5 to 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.

Anticipates consequences of actions and how they impact other areas.

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:

Anticipate potential problems and take proactive action to avoid/minimize impact.

Work in a controlled environment.

Independently prioritize, plan and schedule workflow

Interpret and apply GMPs, relevant laws, guidance's and directives to extremely complex pharmaceutical situations.

Work and coordinate activities across multiple functional groups with a sense of professionalism and urgency.

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.

Good attendance and reliability.

Position Type: Contract

Get in Touch:

We want to hear from you! If you think you'd be a good match, submit your resume and reach out to Lalit at (phone number removed) to learn more.

Who We Are:

Since 1986, Hired by Matrix, Inc., has improved our candidates' lives with exciting job opportunities that provide outstanding career advancement. Hired by Matrix offers our contract professionals competitive salaries, benefits after 60 days, and a 401k option with a company match after one year. Hired by Matrix is an Equal Opportunity Employer and proud to be certified as both a Woman-Owned Business Enterprise and a Woman-Owned Small Business.

Connect with us on LinkedIn today and learn more about how HbM can change your career:

Check out our Career Center:

<!– job description page –>