Title:  Sr Manager Quality Systems

The Senior Manager, Quality Systems is responsible for leading and enhancing the organization's quality systems to ensure compliance with global regulatory requirements and standards. This role oversees key quality systems including deviation management, CAPA, change control, training, document control, and audit readiness. The position plays a strategic role in driving continuous improvement and fostering a culture of quality across the Global Development Organization (GDO) and across GDO supporting functional departments.

Key Responsibilities

• Lead and manage the development, implementation, and maintenance of core quality systems (QMS).
• Collaborate cross-functionally to ensure alignment of quality systems with GDO operational needs; serves 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 alignment of procedural documents across GDO and compliance with applicable GxP regulations and internal standards/requirements where applicable.
• This role participates in internal and external audits as assigned and supports regulatory inspections.
• Lead risk assessments and quality impact evaluations for system changes. Drive continuous improvement initiatives; Lean Six Sigma or similar methodology are a plus.
• Develop and monitor quality metrics and KPIs; report trends at Management Review and ad hoc when critical/major quality events arise to leadership.

• Collaborates with a team of professionals and external parties to ensure compliance and audits are completed; Travel requirement is 15%

Qualifications

• Bachelor’s degree in Life Sciences or related field; certification in biologics, pharmaceuticals, medical devices and/or Quality Management is a plus.
• Minimum 8–10 years of experience in Quality Assurance within a regulated industry.
• Experience with electronic QMS platforms; proven skills and proficiency of quality systems and working in a globally hybrid team atmosphere.
• Strong knowledge of FDA, EMA, ICH guidelines and GxP principles. Familiarity with data governance and digital quality systems.
• Strategic mindset with hands-on execution capability; excellent communication, analytical, and problem-solving skills. 
• Ability to influence cross-functional teams and drive change; effective communications with technical and non-technical colleagues; experience establishing and maintaining effective relationships with leaders and peers.
• Demonstrated capability as organizational change agent; experience in leading and participating in global teams with shared responsibility for outcomes and decision-making.

The presently-anticipated base compensation pay range for this position is $137,000 to $167,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.