Manager, Global Quality Compliance

Job Summary

Manage overall batch review of sterile and OSD manufacturing/packaging records, certificates of analysis/compliance and all related supporting documentation (i.e. documentation review, SOP compliance, instrument preventive maintenance/calibration/qualification/validation as per good manufacturing practices/good documentation requirements and ALCOA++ principles). This role will be an individual contributor with expert level experience in manufacturing investigations from FDA approved facilities that make sterile and OSD products.

Area Of Responsibility

• Subject matter expert (SME) understanding of sterile manufacturing and packaging.
• Leads the review of sterile and OSD manufacturing/packaging records from a Global Quality perspective.
• QA SME for manufacturing (Sterile & OSD), environmental monitoring, microbiology, media-fill & packaging Investigations and related CAPAs.
• Successful experience with FDA inspections
• Ensure that all activities are compliant with Standard Operating Procedure, STP and GP etc.
• Review of equipment qualification, process validation protocols and reports for accuracy, completeness and traceability as well as adherence to the Protocol/procedures.
• Training of colleagues across multiples sites.
• Work in partnership with site Quality Assurance.
• Follow the EHS policy, procedures and maintain the compliance to cGMP requirements.
• Participates and conducts mock inspections to prepare the facility for audits and assesses gaps in the system; review documents for compliance to current regulations and cGMPs.
• Identifies compliance concerns and supports continuous improvements.   
• Performs additional assignments as needed.

Work Conditions:

Corporate Office Environment

Manufacturing / Production Environment

Laboratories

Warehouse Environment

Field Familiarity Environment

Travel Estimate

• Up to  30  %

Education and Job Qualification

• Minimum of Bachelor’s degree
• Thorough understanding of GMPs, specifically those relating to good documentation practices
• Expertise in software applications such as: MS Word, MS Excel, MS Office, Windows, PowerPoint, Microsoft Outlook, Acrobat Reader, TrackWise, LMS (Learning Management System) etc.
• Knowledge of project management principles, practices, techniques and tools
• Strong communication, interpersonal and organizational skills
• The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR)

Experience

• Minimum of five (5) years of experience within the pharmaceutical industry
• Subject matter expert (SME) in sterile manufacturing and packaging required
• Ability to the review of sterile and OSD manufacturing/packaging records from a Global Quality perspective.
• QA SME for manufacturing (Sterile & OSD), environmental monitoring, microbiology, media-fill & packaging Investigations and related CAPAs
• Experience working in an international, multicultural matrix organization