Senior Quality Manager

Job Description

The Senior Manager, GxP Strategic Document Partner supports the Associate Director of GxP Quality Document and Records Management by managing, assessing, and delivering high-impact, compliant documents and records management solutions in alignment with quality objectives, regulatory standards, and business priorities.

The Senior Manager serves as a strategic document partner for assigned area(s) and/or quality system(s), leading document impact and needs analyses and partners with the business to lead Global document initiatives,  supporting a functional document hierarchy which integrates the development, maintenance, and distribution of critical documents that support the organization’s strategic goals and initiatives. This role requires expertise in consulting, solution project management, administration of the document management system (DMS), and regulatory oversight to support the development of effective documentation and management of records which appropriately reflect regulatory requirements and support inspection readiness.

The role collaborates with cross-functional documentation and training  teams, DTE (IT),  and HR to ensure strategies are enabled through technology, including automation and emerging modalities such as AI and Machine Learning, while driving document and records governance and compliance, innovation, and continuous improvement across the GxP document and records program.

Key Responsibilities

• Serve as a strategic document partner for assigned functional areas and/or quality system(s), aligning document development and records management with business, quality, and regulatory expectations

• Act as a liaison between functional area leadership and the GxP Document and Training Strategy and Operations teams, ensuring alignment of documentation goals with operational and quality objectives

• Conduct document impact and needs analyses and supports the functional document hierarchy which integrates the development, maintenance, and distribution of critical documents that support the organization’s strategic goals and initiatives

• Ensure GxP documents are engaging, effective, and compliant, using instructional design and adult learning methodology best practices

• Partner with stakeholders to ensure the document and records management process along with documentation assumes a risk-based approach and reflects current industry and regulatory standards  

• Collaborate with Quality, Document and Training Operations, and business partners to support inspection-ready documentation and records.

• Leverage automation, digital tools, and emerging technologies, including AI and Machine Learning, to optimize documentation processes and content

• Identify opportunities to enhance document and records management processes, content, and delivery methods by leveraging feedback and data-driven insights

• Promote a culture of change by driving continuous improvement initiatives that improve documentation impact and efficiency

• Evaluate documentation quality system effectiveness using appropriate metrics to ensure objectives are met and compliance requirements are achieved

• Support the Associate Director in implementing the strategic documentation and records management roadmap by overseeing the development and delivery of document initiatives

• Collaborate with Strategic Document Partners to ensure consistent and effective application of best-in-class practices across the organization

• Serve as an escalation point for operational challenges, providing solutions to support uninterrupted document operations

• Collaborate with leadership to troubleshoot and resolve document-related issues effectively

• Partner with Strategic Learning Partners to oversee GxP document control processes related to training, ensuring accuracy, accessibility, and compliance of training materials

Minimum Qualifications

• Bachelor’s degree with 5-10 years’ experience in GxP Document and Records Management or in related function, Masters preferred

• Demonstrated fluency in documentation impact assessment and needs analyses, and the development, hierarchy structure, and management of a range of documentation (Standards, SOPs, work instructions, job aids, guidance, training materials) with consideration for applicable regulatory requirements

• Deep expertise in Document Control and Management, technical writing principles, performance consultation, and emerging technologies (AI, machine learning, automation) in alignment with regulatory requirements and inspection readiness

• Experience working with and supporting Biologics and Device, Cell and Gene Therapies, Clinical, and Manufacturing, preferred