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

Physical Requirements:

• Must be capable of bending and lifting, moving and/or carrying up to approximately 10 pounds.

• Ability to navigate office, lab and/or plant floor working environments, stands, ambulates, and reaches.


• Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes.

Travel Estimate

Up to  30  %

Education and Job Qualification

• Minimum of Bachelor’s degree


• Role supporting seminars and courses are an asset.


• Thorough understanding of GMPs, specifically those relating to good documentation practices


• Ability to work effectively in an international multicultural matrix organization


• 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


• Experience working in an international, multicultural matrix organization.