Director of Quality – FDA Readiness & Site Ops Leader

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

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.