Quality & Compliance Director — Audit & CAPA Leader

Actalent, Inc.; North Billerica (MA); On-site; USD 175,000 - 224,000; Full time

Benefits offered by this job

Holiday

Vacation

401k

Bonus

Equity

Job summary

Actalent, Inc. seeks a Director of Quality to lead the quality group with focus on compliance and auditing, ensuring alignment with pharmaceutical and medical device regulations.

The role handles inspection readiness, internal and external audits, customer complaints, and quality management reviews, acting as the process owner for CAPA, change control, and document control. This is a 100% onsite position based in North Billerica, MA, with a competitive pay range of $175000-$224000 per year, plus

Qualifications

• Bachelor's degree required; 15+ years in Quality within pharma/biopharma or medical devices.
• Strong leadership with deep regulatory knowledge and audit experience.
• Proven track record in CAPA, change control, and quality systems.

Responsibilities

• Support and oversee quality group focusing on compliance and auditing.
• Ensure alignment with pharmaceutical and medical device regulations.
• Handle inspection readiness, internal and external audits, and customer complaints.
• Act as process owner for quality events, deviations, CAPA, change control, document control, and training.
• Develop and implement quality systems and surveillance.

Skills

Compliance

Audit

External audit

Quality assurance

CAPA

Change control

Document control

Quality systems

Customer complaints

Regulatory

Risk management

Reporting

Education

Bachelor's degree in a related medical, science, or business discipline

Job description

Actalent, Inc. seeks a Director of Quality to lead the quality group with focus on compliance and auditing, ensuring alignment with pharmaceutical and medical device regulations.

The role handles inspection readiness, internal and external audits, customer complaints, and quality management reviews, acting as the process owner for CAPA, change control, and document control. This is a 100% onsite position based in North Billerica, MA, with a competitive pay range of $175000-$224000 per year, plus