Browse by job sector

Project Manager - QA

  1. North America, United States
North Carolina
  1. Contract
Competitive
  1. CAPEX Projects
36143

This vacancy has now expired

Project Manager - QA - PMO - Pharma - North Carolina - 12-Month Contract 

Our client, a global pharmaceutical manufacturing organization are looking for a talented Project Manager to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.


Key Responsibilities:
  • Assess the current state of quality systems, identify gaps, and create a comprehensive plan to prepare the site for regulatory inspections.
  • Oversee the implementation of GMP documentation, change controls, deviation management, and CAPAs, ensuring alignment with FDA, EMA, and ICH guidelines.
  • Lead quality-related projects focused on validation readiness, data integrity, training programs, and compliance initiatives, ensuring smooth site startup and operational success.
  • Partner with CQV, Manufacturing, Supply Chain, and Regulatory teams to align quality objectives with startup timelines and ensure seamless integration of QA processes.
  • Act as a QA SME, providing guidance, oversight, and coaching to ensure site teams understand compliance expectations and regulatory best practices.
  • Develop and optimize quality workflows, audit strategies, and deviation management frameworks to enhance site-wide compliance.

Required Skills & Experience:
  • Proven experience in quality assurance project management within biotech or pharmaceutical manufacturing, with a focus on GMP compliance, validation, and regulatory inspection readiness.
  • Strong understanding of quality risk management, data integrity (ALCOA+), and quality system frameworks.
  • Ability to "speak the language" of compliance, quality systems, and site readiness—understanding regulatory expectations, audit preparation, and deviation management.
  • Hands-on experience with batch record review, change control, SOP development, and CAPA implementation.
  • Expertise in hosting and preparing for regulatory inspections (FDA, EMA, MHRA, etc.), ensuring that teams are aligned and prepared for site audits.
  • Excellent time management, problem-solving, and communication skills, with the ability to adapt in a fast-paced, evolving environment.
  • Experience managing KPIs, reporting structures, governance meetings, and infrastructure planning.
  • Ability to build relationships and effectively collaborate in a global team environment.

If this role is of interest to you, please apply now! 

 #LI-NR1
Save as a job alert
List #1

Similar Jobs

Project Planner

Salary

Competitive

Location

Odense

Salary

Competitive

Sector

CAPEX Projects

Compliance / Quality Assurance

Job type

Contract

Location

Denmark

Description

Project Planner - Denmark, Odense -  12 Month Contract  Are you looking for your next Project Planner role? QCS has the position for you! Our client, long-standing number one provider of

Reference

36414

Expiry Date

01/01/0001

Iain Dickens

Author

Iain Dickens
Iain Dickens

Author

Iain Dickens
Read more Shortlist this job
Read more Shortlist this job
CAD Designer

Salary

Competitive

Location

Dublin

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Ireland

Dublin

Description

CAD Designer - Dublin, Ireland - 12 Months Contract One of the top 10 best companies to work in Ireland is looking for CAD Designer for their large-scale new facility in Dublin. Is this you?

Reference

36694

Expiry Date

01/01/0001

James Smithson

Author

James Smithson
James Smithson

Author

James Smithson
Read more Shortlist this job
Read more Shortlist this job
Risikomanager /in (m/w/d)

Salary

Competitive

Location

Berlin

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Germany

Central Germany

Description

Risikomanager /in (m/w/d) - Deutschland - 18-monatige Vertragsposition Wir rekrutieren im Auftrag eines führenden globalen Pharmaunternehmens mit Sitz in der Umgebung von Germany. Aufgrund

Reference

36675

Expiry Date

01/01/0001

Peter Hallam

Author

Peter Hallam
Peter Hallam

Author

Peter Hallam
Read more Shortlist this job
Read more Shortlist this job

Insights

Living and working in North Carolina
Read more

03/26/2024

Living and Working in Michigan
Read more

10/25/2023

Living and Working in Chicago

Read more

08/18/2023

VIEW ALL

Send us your CV

Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.

Upload your CV