Sr Manager Quality Systems

Sun Pharmaceutical Industries Ltd•Billerica, MA

10d•$137,000 - $167,500

About The Position

The Senior Manager, Quality Systems leads and enhances the organization's quality systems to ensure compliance with global regulatory requirements and standards. The role oversees deviation management, CAPA, change control, training, document control, and audit readiness. It drives continuous improvement and fosters a culture of quality across the Global Development Organization (GDO) and its supporting functional departments. The position collaborates with internal teams and external parties to support compliance and audit completion, and has a travel requirement of 15%.

Requirements

Bachelor’s degree in Life Sciences or a related field.
Minimum 8–10 years of experience in Quality Assurance within a regulated industry.
Experience with electronic QMS platforms and demonstrated proficiency in quality systems.
Strong knowledge of FDA, EMA, and ICH guidelines and GxP principles.
Strategic mindset with hands-on execution capability.
Excellent communication, analytical, and problem-solving skills.
Ability to influence cross-functional teams and drive change.
Ability to communicate effectively with technical and non-technical colleagues and maintain effective relationships with leaders and peers.
Demonstrated capability as an organizational change agent.
Experience leading and participating in global teams with shared responsibility for outcomes and decision-making.

Nice To Haves

Certification in biologics, pharmaceuticals, medical devices, and/or Quality Management.
Familiarity with data governance and digital quality systems.
Experience working in a globally hybrid team atmosphere.
Lean Six Sigma or a similar methodology.

Responsibilities

Lead and manage the development, implementation, and maintenance of core quality systems (QMS).
Collaborate cross-functionally to align quality systems with GDO operational needs; serve as QA Lead and system owner for Deviation, CAPA, Change Control, Training, and Document Management processes.
Author and approve SOPs, policies, and training materials related to quality systems.
Ensure procedural documents are aligned across GDO and comply with applicable GxP regulations and internal standards and requirements.
Participate in internal and external audits as assigned and support regulatory inspections.
Lead risk assessments and quality impact evaluations for system changes.
Drive continuous improvement initiatives.
Develop and monitor quality metrics and KPIs, and report trends at Management Review and ad hoc when critical or major quality events arise.
Collaborate with professionals and external parties to ensure compliance and audits are completed.