Quality Systems Lead — CAPA, Deviation, Change Control

Sun Pharmaceutical Industries, Inc.; Billerica (MA); On-site; USD 137,000 - 168,000; Full time

Job summary

Sun Pharmaceutical Industries, Inc (USA) seeks a Senior Manager, Quality Systems to lead and enhance core quality systems ensuring compliance with global regulatory requirements and GxP standards. The role oversees deviation management, CAPA, change control, training, document control, and audit readiness within the Global Development Organization.

Responsibilities include developing, implementing, and maintaining QMS, auditing readiness, and driving continuous improvement while leveraging Lean

Qualifications

• Bachelor’s degree in Life Sciences or related field; QA certification is a plus.
• Minimum 8–10 years of experience in Quality Assurance within a regulated industry.
• Experience with electronic QMS platforms; strong knowledge of quality systems and global teams.

Responsibilities

• Lead and manage development, implementation, and maintenance of core quality systems (QMS).
• Collaborate cross-functionally to align quality systems with GDO needs; QA lead for Deviation, CAPA, Change Control, Training and Document Management.

Skills

Quality systems

GxP knowledge

Regulatory compliance

Cross-functional leadership

Education

Bachelor's in Life Sciences

Quality management certification (preferred)

Tools

Electronic QMS

Job description

Sun Pharmaceutical Industries, Inc (USA) seeks a Senior Manager, Quality Systems to lead and enhance core quality systems ensuring compliance with global regulatory requirements and GxP standards. The role oversees deviation management, CAPA, change control, training, document control, and audit readiness within the Global Development Organization.

Responsibilities include developing, implementing, and maintaining QMS, auditing readiness, and driving continuous improvement while leveraging Lean