PV Compliance & Training Manager I
True Title: GDS Compliance Process and Standards
Please note this is NOT a training role. True job title is GDS Compliance Process and Standards (GxP regulations, SOPs). This is a 6-month role
• Review of existing policies, standard operating procedures (SOPs), job aids, training content and other types of controlled documents to identify gaps and inconsistencies for Global Drug Safety (GDS) within R&D, documentation of findings, and assist with updates to the documents as required.
• Review controlled process documents to ensure submitted procedures are compliant and meet the requirements of R&D document control procedures.
• Perform Quality Control reviews on process document content and formatting to identify any gaps.
• Maintain the documentation related to gaps identified in the procedural documents.
• Work with subject matter experts and key functional department personnel to ensure accurate content of required documentation. Recommend revisions or changes in scope, formatting, and content as identified.
• Maintain and coordinate activities related to the document update using the electronic document management system (EDMS) including document initiation, workflow support, revision, and retirement, as required.
Education & Qualifications
• Minimum of five (5) years of experience writing controlled documentation in the biotechnology or pharmaceutical industry
• Direct experience in GXP-compliant quality systems is preferred
• Experienced in Microsoft office applications specifically Word, Excel and Visio
• Ability to maintain keen attention to detail with a high regard for quality, efficiency, and processes
• Excellent communication skills including: technical writing, interpersonal and
• collaborative skills
• Excellent organization skills with the ability to stay accountable to deliverables and milestones
• Ability to thrive and multi-task in a fast-paced environment
• Must have in-depth knowledge and understanding GXP regulations, and controlled document management principles
• Must work effectively in a team environment and with individuals at all levels within an organization.
• This is a 6 month contractual opportunity.
• Medical, Dental, and Vision Insurance
• 401K Plan with Company Match
• Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.