Senior Quality Manager — Compliance, Audits & CI

Regulatory Jobs; Marlborough (MA); In loco; USD 135.000 - 190.000; Tempo pieno

Vantaggi offerti da questo lavoro

Paid time off

Health/dental/vision

Retirement benefits

Flexible spending accounts

Descrizione del lavoro

Regulatory Jobs in Marlborough, MA is seeking a Senior Manager, Quality to lead and strengthen quality systems across the site. You will drive continuous improvement, mentor a high‑performing team, and partner with global quality to advance enterprise-wide processes.

You will develop and monitor quality metrics, support internal and external audits, and oversee CAPA activities to ensure compliance and operational excellence. This role emphasizes data-driven decisions and a culture of quality.

Competenze

• Bachelor's degree in Chemistry, Biology, Engineering, or a related scientific discipline.
• Minimum of 10 years of experience within an ISO 9001, ISO 13485, cGMP, or comparable regulated quality environment.
• Minimum of 4 years of people leadership experience, including coaching, mentoring, and developing direct reports.
• Demonstrated expertise in Quality Management Systems, auditing, CAPA, document control, validation, and nonconforming material processes.
• Strong knowledge of Good Documentation Practices (GDP), root cause analysis methodologies, and quality investigation processes.
• Experience developing, tracking, and reporting quality metrics to drive performance and continuous improvement.
• Proven ability to lead cross-functional initiatives and influence stakeholders at multiple levels of the organization.
• Strong organizational, problem-solving, and project management skills, with the ability to balance strategic priorities and day-to-day execution.
• Experience leading quality system improvements, transformation initiatives, or digitalization projects preferred.
• Lean, continuous improvement, or operational excellence experience preferred.
• Excellent communication, collaboration, and relationship-building skills.
• Demonstrated commitment to fostering a positive quality culture and developing high-performing teams.

Mansioni

• Maintain compliance with ISO 9001 and applicable quality requirements across all aspects of the Quality Management System, including internal and external audits, CAPA, nonconforming material management, validation activities, and document control.
• Lead, mentor, and develop direct reports, fostering a high-performing team culture built on accountability, collaboration, and continuous learning.
• Drive quality excellence initiatives that strengthen quality culture, improve organizational effectiveness, and support long-term business objectives.
• Partner with site leadership and global quality stakeholders to support the continued development and implementation of enterprise-wide quality management processes.
• Develop, monitor, analyze, and communicate quality metrics and KPIs to assess organizational quality health, identify trends, and drive data-based decision making.
• Lead or support internal and external audit programs, ensuring timely execution, effective root cause analysis, and completion of corrective and preventive actions.
• Oversee document control processes and ensure quality procedures, policies, and records remain compliant, effective, and current.
• Provide quality oversight for investigations, deviations, nonconforming materials, out-of-specification results, and CAPA activities, ensuring appropriate risk assessment and resolution.
• Identify and implement continuous improvement opportunities that increase efficiency, strengthen compliance, and enhance overall quality system effectiveness.
• Champion strategic quality projects, including digital transformation initiatives such as the transition from paper-based quality documentation and certificates to electronic quality systems.
• Collaborate effectively with cross-functional teams to support product release activities, operational priorities, and broader business initiatives.
• Utilize risk-based decision making to maintain compliance while enabling business success.

Conoscenze

Quality management systems

Auditing

CAPA

Document control

Root cause analysis

KPIs and metrics

Risk management

Leadership

Lean CI

Digital transformation

Cross-functional collaboration

Formazione

Bachelor's degree in Chemistry, Biology, Engineering, or related discipline

Descrizione del lavoro

Regulatory Jobs in Marlborough, MA is seeking a Senior Manager, Quality to lead and strengthen quality systems across the site. You will drive continuous improvement, mentor a high‑performing team, and partner with global quality to advance enterprise-wide processes.

You will develop and monitor quality metrics, support internal and external audits, and oversee CAPA activities to ensure compliance and operational excellence. This role emphasizes data-driven decisions and a culture of quality.