Manager, QMS

Role Summary

Manager of the Quality Management System (QMS) is responsible for the overall development, implementation, and maintenance of the company's quality assurance processes. This leadership role ensures that the organization's products, services, and operations meet internal and external standards, regulatory requirements, and customer expectations. The manager drives a culture of continuous improvement throughout the company. Performs a wide variety of activities within Quality Assurance (QA) to ensure compliance with regulatory and company requirements in support of the Quality Management System.

Responsibilities

• Responsible for supporting QMS functions: Change Management and Document Control
• Review and approve change requests and documents for compliance and adherence to company requirements.
• Work with change control and document authors to ensure documents are clear, comprehensive and align with other documents in the quality system.
• Assess processes and recommend process/system improvements.
• Independently resolve issues related to compliance and document quality whenever possible.
• Ability to assess impact of change requests, liaison to Change Management Review Board.
• Support notification and approval for partner changes.
• Author SOPs, change controls and other quality system documents.
• Obtain consensus from document approvers.
• Provide guidance on compliance issues identified and questions raised by colleagues (inter-departmental and intra-departmental).
• Represent QA on various teams and projects.
• Perform data entry and execute records in electronic systems.
• Collaborate cross-functionally to ensure timely review and approval of Change Controls & SOPs, fostering alignment and minimizing delays.
• Track and monitor progress of Change Controls and SOPs to ensure timely revisions and compliance.
• Maintain tracking logs and files as required.
• Support and/or participate in audits/inspections.

Qualifications

• BA/BS degree in a scientific or technical discipline with 7-10 years or MS/MBA degree with 5-7 years related experience preferably in the pharmaceutical industry or the combination equivalent of training and experience.
• Strong knowledge of quality standards and quality improvement methodologies
• Experience in reviewing/writing change controls and document review for regulatory compliance is preferred.
• Excellent written and verbal communication skills.
• Excellent leadership, communication, and problem-solving skills, with a strong ability to work collaboratively with cross-functional teams.
• Ability to work autonomously to problem-solve, demonstrating excellent analytical skills.

Skills

• Quality management systems (QMS) administration
• Change control and document management
• Regulatory compliance and internal audits
• SOP development and documentation
• cross-functional collaboration

Education

• BA/BS or MS/MBA in a scientific or technical discipline

Additional Requirements