Director of Quality

Hyper Recruitment Solutions; Massachusetts; On-site; USD 220,000 - 320,000; Full time

Job summary

Hyper Recruitment Solutions is seeking a Director of Quality to lead site quality operations at a major biopharmaceutical site in Massachusetts. This senior role will drive FDA inspection readiness, ensure cGMP compliance, and lead a fast-paced manufacturing quality function, including QC and QA oversight.

You will set the site Quality strategy, mentor a multi-disciplinary team, and partner with Operations, Regulatory, and Supply Chain to deliver compliant and efficient outcomes.

Qualifications

• Proven experience in a senior Quality leadership role within biopharmaceutical/pharmaceutical manufacturing.
• Strong knowledge of FDA / cGMP expectations and demonstrated inspection readiness leadership.
• Experience leading multi-disciplinary Quality teams, including QC (and ideally QA/QMS oversight).
• Confident stakeholder management skills, with the ability to influence across site and global functions.

Responsibilities

• Lead overall site Quality operations, setting direction, standards, and performance expectations.
• Drive and support global FDA readiness / inspection preparedness programmes, ensuring the site is audit-ready at all times.
• Lead, develop, and mentor a busy Quality organisation, including Quality Control (QC) teams.
• Own and improve core Quality systems (e.g., deviations, CAPA, change control, risk management, training, documentation).
• Partner cross-functionally with Operations, Supply Chain, Engineering, and Regulatory to deliver compliant and efficient outcomes.
• Promote a strong quality culture, with a focus on right-first-time behaviours and continuous improvement.

Skills

Quality leadership

FDA readiness

cGMP knowledge

Stakeholder management

Job description

We are currently looking for a Director of Quality to join a leading biopharmaceutical company out of Massachusetts. This is a senior leadership opportunity to drive site quality operations, strengthen global inspection readiness, and lead a high-performing Quality function (including QC) in a fast-paced manufacturing environment. As the Quality Director, you will take ownership of the site Quality strategy and day-to-day Quality operations. You’ll partner with global stakeholders to deliver FDA inspection readiness programmes, ensure sustained compliance, and continuously improve Quality systems across the business.

KEY DUTIES AND RESPONSIBILITIES

Your duties as the Quality Director will be varied; however, the key duties and responsibilities are as follows:

• Lead overall site Quality operations, setting direction, standards, and performance expectations.
• Drive and support global FDA readiness / inspection preparedness programmes, ensuring the site is audit-ready at all times.
• Lead, develop, and mentor a busy Quality organisation, including Quality Control (QC) teams.
• Own and improve core Quality systems (e.g., deviations, CAPA, change control, risk management, training, documentation).
• Partner cross-functionally with Operations, Supply Chain, Engineering, and Regulatory to deliver compliant and efficient outcomes.
• Promote a strong quality culture, with a focus on right-first-time behaviours and continuous improvement.

ROLE REQUIREMENTS

To be successful in your application to this exciting role as the Quality Director, we are looking to identify the following on your profile and past history:

• Proven experience in a senior Quality leadership role within biopharmaceutical / pharmaceutical manufacturing.
• Strong knowledge of FDA / cGMP expectations and demonstrated inspection readiness leadership.
• Experience leading multi-disciplinary Quality teams, including QC (and ideally QA/QMS oversight).
• Confident stakeholder management skills, with the ability to influence across site and global functions.

WHAT’S IN IT FOR YOU?

This is a highly visible leadership role with the opportunity to make a genuine impact on Quality performance and regulatory readiness at a leading biopharmaceutical site.

Key Words:

Quality Director / Director of Quality / Site Quality / QA / QC / cGMP / FDA readiness / inspection readiness / quality systems / CAPA / deviations / change control / Massachusetts

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements.