Title: Sr Mgr Quality Compliance
Duration: 12 Months (Possible Extension)
Location: Fully Remote
 
Top 3 Must-Have Skill Sets

• Significant experience in Quality Management, Document Management, Compliance, or other relevant area of pharmaceutical/biotech industry
• Document and process management experience
• Change management expertise
• Clinical Trial experience and/or knowledge of ICH GCP

 
Job Summary
The Process Documentation Management CW is responsible for delivering quality leadership in process documentation for significant internal change initiatives. This role provides clear quality requirements for process documents, exemplifies strong partnership skills, and ensures compliance and timely completion of documentation creation and revisions.
 
Basic Qualifications

• Doctorate degree and 2 years of R&D or Quality experience
  Or
• Master’s degree and 6 years of R&D or Quality experience
  Or
• Bachelor’s degree and 8 years of R&D or Quality experience
  Or
• Associate degree and 10 years of R&D or Quality experience
  Or
• High school diploma / GED and 12 years of R&D or Quality experience
  And
• 2 years of leadership experience leading teams, projects, programs, or advising the allocation of resources

 
Preferred Qualifications

• Bachelor’s degree in appropriate field or other advanced degree (Preferred)
• Significant experience in Quality Management, Document Management, Compliance, or other relevant area of pharmaceutical/biotech industry
• Document and process management experience
• Change management expertise
• Clinical Trial experience and/or knowledge of ICH GCP

 
Day to Day Responsibilities

• Set strategy for R&D controlled document management at project or program level to best enable the client's R&D Strategy in partnership with applicable Global Process Owners
• Ensure compliance to the client Document hierarchy and standards for R&D
• Oversee and provide quality input for the development of clinical trial processes and standards that lead to controlled documents that describe end-to-end processes
• Adapt and implement technical and digital technology solutions to further compliance and end user ability to follow standard documentation
• Lead all aspects of and ensure that R&D controlled documents meet the regulations and any additional client obligations / regulatory commitments, putting effective document content controls in place to assure compliance
• Partner with other Quality functions to ensure robust and aligned quality and compliance advice on good documentation practices and other quality aspects (e.g., planned deviations and inspection readiness)
• Identify, prioritize and remediate gaps in the Quality Management System related to process document management

 
Possible Extension: Yes
Red Flags: No GCP or document authoring experience
Interview Process: Teleconference panel interview (1 or 2) available immediately to start interviewing
  
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 60.00/hr.