Regulatory Compliance Manager

1 month ago


Bangor, Maine, United States Biospectra Inc Full time
Job Summary:

BioSpectra Inc. is seeking an experienced Regulatory Compliance Manager to join our team. As a key member of our compliance team, you will be responsible for ensuring that all BioSpectra sites are always audit-ready through the performance of Compliance Inspections and Internal Audits. You will also ensure Customer Audits are executed in accordance with BioSpectra and Industry expectations.

Key Responsibilities:
  • Ensure BioSpectra's Quality and Regulatory Programs and Systems are compliant with applicable regulatory standards, BioSpectra Policies and Customer Expectations.
  • Prepares, compiles and maintains Regulatory dossiers including Drug Master Files, Veterinary Master Files, and Active Substance Master Files
  • Authors, reviews and approves regulatory packets, quality policies and procedures
  • Prepares and if required hosts customer and regulatory agency paper-based, virtual, and on-site audits and post audit activities and reports the events of the audit to key personnel.
  • Executes the Customer Audit Program to ensure audits and follow up activities are compliant to internal, customer, and regulatory standards.
  • Manages and executes the Compliance Inspection Program to ensure all sites are always audit ready
  • Manages and executes BioSpectra's internal audit program and ensures compliance with current to regulatory standards and guidelines
  • Lead Auditor for Internal Audits for the following systems Facilities and Equipment, Materials, Quality, Laboratory Controls, Production, and Packaging and Labeling operations or other records and data to determine the efficiency and effectiveness of systems.
  • Completes Internal Audit Effectiveness Assessments to determine if an internal audit closure has been completed successfully or requires additional root cause analysis and CAPA.
  • Coordinates with BioSpectra Departments for any Compliance Program related Corrective and Preventative Actions including assessment for Compliance to BioSpectra's Quality Agreements with Customers.
  • Completes required regulatory and compliance documentation requests to support product commercialization.
  • Reviews current and new Guidance Documents and implements an action plan for BioSpectra to incorporate any changes to the current Quality management System.
  • Other duties may be assigned as deemed appropriate by the Director of Compliance
Requirements:
  • Four-year degree in Science or related field
  • 5 years minimum experience working in a cGMP environment ideally Active Pharmaceutical Ingredient related
  • Has a working knowledge and understanding of ICH Q7, 21 CFR 210 and 211, Part 11 and Annex 11
  • Knowledge of Global Regulatory Affairs including but not limited to United States, European, Canada, and Asia
  • Ability to define problems, collect data, establish facts and draw valid conclusions
  • Experience with relevant software applications including MS Office, Excel, Minitab and Adobe
  • Ability to communicate effectively with staff, management, customers and/or regulatory agencies
  • Ability to handle sensitive information in a confidential manner
  • Close vision, distance vision, ability to adjust focus, ability to distinguish color change, and the ability to use a computer for extended periods of time.
Work Hours:
  • Exempt Position; Shift Hours: 8am to 5pm
  • Minimum of 45-50 Hours Week, or other agreed upon documented schedule
  • Ability and willingness to work from all BioSpectra facilities

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