Site Quality Lead — Regulatory Excellence & CAPA

Curia Aalborg ApS; Hopkinton (MA); On-site; USD 206,000 - 251,000; Full time

Benefits offered by this job

Generous benefit options (eligible on

Paid training, vacation and holidays

Career advancement opportunities

Education reimbursement

401K program with matching

Learning platform

And more!

Job summary

Curia is seeking a Site Quality Head in Hopkinton, MA to lead quality systems, compliance and continuous improvement at the site level. You will guide senior quality leaders, ensure FDA and cGMP compliance, and drive proactive CAPA execution while partnering with global teams.

The role demands a bachelor’s degree in science, 10+ years in aseptic production and 5+ years in management, with strong leadership, strategic thinking and cross-functional collaboration to sustain best-in-class quality

Qualifications

• Bachelor's degree in science or relevant field and at least 10 years in aseptic production with 5 years in management.
• Ability to build relationships across organizations and sites.
• Strategic leadership and execution of quality programs.

Responsibilities

• Oversee day-to-day Quality Systems operations.
• Lead and develop the Quality staff through coaching.
• Collaborate with global teams to enforce quality standards and regulatory compliance.
• Ensure CAPAs are implemented within defined timeframes.
• Oversee change controls, validation, and environmental monitoring in manufacturing.
• Own change requests and related documentation.
• Ensure processes meet cGMP and Curia policies.

Skills

Leadership

Relationship building

Strategic leadership

Regulatory understanding

Financial interpretation

Communication across levels

Education

Bachelor's degree in science or relevant field

Job description

Curia is seeking a Site Quality Head in Hopkinton, MA to lead quality systems, compliance and continuous improvement at the site level. You will guide senior quality leaders, ensure FDA and cGMP compliance, and drive proactive CAPA execution while partnering with global teams.

The role demands a bachelor’s degree in science, 10+ years in aseptic production and 5+ years in management, with strong leadership, strategic thinking and cross-functional collaboration to sustain best-in-class quality