Manager, Manufacturing Compliance

8 - 10 years experience  • 

Salary depends on experience
Posted on 04/18/18
Baltimore, MD
8 - 10 years experience
Salary depends on experience
Posted on 04/18/18

Key Responsibilities:

  • Management of the compliance function and team for GMP manufacturing compliance
  • Responsible for ensuring documentation including batch records, SOPs, logbooks, etc. that will be used throughout the manufacturing facility
  • Adheres to internal/external guidelines, specifications, and regulatory requirements while creating and maintaining documentation
  • Ensures that SOPs relevant to documentation (batch records, logbooks, etc.) are generated, maintained and available
  • Tracks GMP review and production close out of batch record documentation
  • Key contact with Quality Assurance to ensure robust and stable document flow from issuance to archiving
  • Positively interacts with internal associates to quickly and effectively resolve issues
  • Addresses deficiencies and ensures completion of all follow-up actions, specifically those that target process fixes to maintain consistent resolutions to all batch review issues according to GMP standards and company objectives
  • Supports implementation of CAPAs, SOP revisions, quality improvement initiatives, operational excellence projects, etc.
  • Develops processes for batch records including for issuing, tracking and reviewing batch records
  • Develops and maintains metrics to track batch record turnaround time, errors and document related deviations

Education / Experience:

  • Bachelor’s degree in Chemistry, Life Science or Engineering field
  • 8+ years of broad cGMP production experience, with knowledge and understanding of process, documentation requirements and activities, preferably in an biologics manufacturing environment
  • 3 years in a leadership role
  • Extensive experience with GMP documentation management

To fully optimize the view of this job posting and the application process please use Google Chrome.

Not the right job?
Join Ladders to find it.
With a free Ladders account, you can find the best jobs for you and be found by over 20,0000 recruiters.