Senior GxP Documentation & Compliance Lead

BioSpace; Plainsboro Township (NJ); On-site; USD 116,810 - 216,100; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) savings plan

Tuition reimbursement

Job summary

A leading healthcare organization is seeking a Senior Patient Safety and GxP Document Oversight Manager in Plainsboro Township, NJ. This role involves overseeing GxP documentation, ensuring compliance, and collaborating across departments. The ideal candidate will hold a relevant degree and possess over 7 years in documentation management, with strong interpersonal and analytical skills to support regulatory requirements and continuous improvement initiatives in a dynamic environment.

Qualifications

• 7+ years of experience in documentation management, quality assurance, or regulatory compliance within pharmaceutical or biotechnology industry.
• Strong knowledge of GxP regulations and documentation standards.
• Proven experience in auditing and process improvement.

Responsibilities

• Oversee all aspects of GxP documentation management.
• Develop and implement documentation management systems for GxP compliance.
• Conduct audits of GxP documentation.

Skills

Documentation management

Quality assurance

Regulatory compliance

Analytical skills

Interpersonal skills

Communication skills

Education

Bachelor's degree in relevant field

Advanced degree (preferred)

Tools

Documentation management software

Microsoft Office Suite (Word, Excel, PowerPoint)

Job description

A leading healthcare organization is seeking a Senior Patient Safety and GxP Document Oversight Manager in Plainsboro Township, NJ. This role involves overseeing GxP documentation, ensuring compliance, and collaborating across departments. The ideal candidate will hold a relevant degree and possess over 7 years in documentation management, with strong interpersonal and analytical skills to support regulatory requirements and continuous improvement initiatives in a dynamic environment.