Quality Systems Leader — GxP, CAPA & Change Control

Sun Pharma; Billerica (MA); Hybrid; USD 137,000 - 168,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life Insurance

Disability Insurance

401(k) plan

Flexible Spending Accounts

Employee Assistance Program

Paid time off

Job summary

Sun Pharmaceutical Industries, Inc (USA) seeks a Senior Manager, Quality Systems to lead and enhance quality systems across the organization, ensuring compliance with global regulatory requirements. The role oversees deviation management, CAPA, change control, training, document control, and audit readiness, with a focus on continuous improvement.

The position collaborates with the Global Development Organization and supporting departments, with a 15% travel requirement.

Qualifications

• Bachelor's degree in Life Sciences or related field required.
• Minimum 8-10 years of experience in Quality Assurance within a regulated industry.
• Experience with electronic QMS platforms and quality systems.
• Strong knowledge of FDA, EMA, ICH guidelines and GxP principles.

Responsibilities

• Lead development, implementation, and maintenance of core quality systems (QMS).
• Coordinate cross-functional alignment of quality systems with GDO needs; QA Lead for Deviation, CAPA, Change Control, Training and Document Management.
• Author and approve SOPs, policies, and training materials related to quality systems.
• Ensure documents comply with GxP and internal standards; participate in audits and regulatory inspections.
• Lead risk assessments and quality impact evaluations for system changes; pursue continuous improvement.

Skills

Quality Assurance

Regulatory compliance

GxP knowledge

FDA/EMA/ICH guidelines

Cross-functional collaboration

QMS systems

Lean Six Sigma

Education

Bachelor's degree in Life Sciences

Certification in biologics/pharmaceuticals/medical devices/Quality Management

Tools

Electronic QMS platforms

Quality systems tools

Job description

Sun Pharmaceutical Industries, Inc (USA) seeks a Senior Manager, Quality Systems to lead and enhance quality systems across the organization, ensuring compliance with global regulatory requirements. The role oversees deviation management, CAPA, change control, training, document control, and audit readiness, with a focus on continuous improvement.

The position collaborates with the Global Development Organization and supporting departments, with a 15% travel requirement.