Sr. Manager, GxP Documentation Control

The Role

In this role, you will be responsible for overseeing the management and maintenance of our GxP documentation and records system and processes across our global GxP organization.

Here’s What You’ll Do

• Leadership and Strategy:

• Maintain and continuously improve our comprehensive global strategy for GxP documentation and records management, ensuring compliance with regulatory requirements and industry best practices reflected in the relevant policies, procedures, and associated documentation.

• Provide strategic direction and guidance to global and local teams supporting document control, records management and archival as well as cross-functional teams on document control, document lifecycle management, and records management processes.

• Engage with Digital Business Partners to establish a cohesive roadmap supporting the compliance and dynamic business needs of the electronic document management system.

• Act as the Quality Systems Document Control and Records management Subject Matter expert for internal stakeholders and in support of third party audit and external health authority inspections.

• Develop appropriate metrics to monitor the health of systems and processes.

• Identify and assign appropriate deputies to support business in times of absence.

• Set clear goals, objectives, and expectations for team members and monitor execution.

• Provide guidance and direction to employees in alignment with organizational strategies and priorities.

• Inspire and motivate team members to achieve their full potential.

• Establish succession plan(s) and employee development plans to support them.

• Foster a positive and inclusive work culture that promotes collaboration, innovation, and continuous improvement.

• GxP Documentation Management:

• Oversee the creation, review, approval, and revision of GxP documents, including Standard Operating Procedures (SOPs), protocols, batch records, and other controlled documents.

• Ensure document control procedures are in place and followed, maintaining the accuracy, integrity, and availability of GxP documents.

• Collaborate with stakeholders to establish and maintain document templates, formatting standards, and version control systems.

• Records Management:

• Maintain and improve the global records management program, including the classification, retention, and disposition of GxP records in compliance with regulatory requirements throughout the complete document lifecycle including chain of custody and associated data integrity.

• Establish procedures for the identification, capture, and indexing of records, ensuring easy retrieval and accessibility.

• Manage controls for long term storage and required retention periods.

• Stay up to date with evolving regulatory requirements and industry trends related to records management and implement necessary changes to maintain compliance.

• Training and Compliance:

• Develop and deliver training programs on GxP documentation and records management to ensure employees understand and adhere to relevant procedures and guidelines.

• Oversee the periodic review process of controlled documents and related content.

• Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.

• Continuous Improvement:

• Identify opportunities for process improvement and automation in GxP documentation and records management, leveraging technology solutions and machine learning capabilities.

• Lead or participate in cross-functional initiatives to enhance efficiency, accuracy, and compliance in document and records management practices.

• Additional duties as may be assigned from time to time

Here’s What You’ll Need (Basic Qualifications)

• Education: Bachelor's degree in a scientific or related field.

• Experience: Minimum of 8 years of experience in GxP document control and records management within the pharmaceutical, biotechnology, or related industry.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Strong knowledge of global regulatory requirements (FDA, EMA, ICH) and industry standards related to GxP documentation and records management.

• Proven experience in leading and managing teams, with excellent leadership and interpersonal skills.