Full-Time

Sr. Manager

Gxp Documentation Control

Confirmed live in the last 24 hours

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines for health

Biotechnology
Healthcare

Senior

Norwood, MA, USA

70/30 work model requires 70% in-office presence.

Category
Public Health
Biology & Biotech
Requirements
  • Bachelor's degree in a scientific or related field.
  • Minimum of 8 years of experience in GxP document control and records management within the pharmaceutical, biotechnology, or related industry.
  • 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.
  • Familiarity with electronic document management systems (e.g., Veeva QualityDocs) and records management software.
  • Strong attention to detail, organizational skills, and ability to prioritize and manage multiple projects simultaneously.
  • Excellent written and verbal communication skills, with the ability to effectively collaborate and communicate with stakeholders at all levels of the organization.
Responsibilities
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Moderna focuses on developing medicines using messenger RNA (mRNA), which is a crucial component in how cells produce proteins necessary for various biological functions. Their approach involves creating a new class of medicines that utilize mRNA to instruct cells to produce specific proteins, potentially leading to significant advancements in treatment options for patients. Unlike traditional pharmaceuticals, which often rely on chemical compounds, Moderna's mRNA-based therapies aim to enhance the discovery, development, and manufacturing processes of medicines. The company's goal is to harness the power of mRNA to improve patient outcomes and create effective treatments for a range of diseases.

Company Stage

IPO

Total Funding

$5.9B

Headquarters

Cambridge, Massachusetts

Founded

2010

Growth & Insights
Headcount

6 month growth

4%

1 year growth

16%

2 year growth

55%
Simplify Jobs

Simplify's Take

What believers are saying

  • mRNA technology is expanding into personalized cancer vaccines, revolutionizing treatment.
  • Recent advancements in lipid nanoparticle delivery enhance mRNA vaccine efficacy.
  • Global mRNA vaccine market projected to grow significantly, boosting Moderna's prospects.

What critics are saying

  • Potential exclusion from Nasdaq 100 could impact investor perception and liquidity.
  • Bypassing safety steps in Australia may raise regulatory scrutiny.
  • Geopolitical tensions in China pose operational and financial risks for Moderna.

What makes Moderna unique

  • Moderna is pioneering mRNA technology for a new class of medicines.
  • The company has developed one of the earliest and most effective COVID-19 vaccines.
  • Moderna's mRNA platform enables rapid development of vaccines for various diseases.

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