Manager, Global Quality Compliance

About the Role 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. What You'll Do

• Lead 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.
• 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.
• Travel up to 30%. What We're Looking For
• Minimum of Bachelor’s degree.
• 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).
• Knowledge of project management principles, practices, techniques and tools.
• Strong communication, interpersonal and organizational skills.
• English language proficiency at Intermediate-B1+ (CEFR).
• Experience: Minimum of five (5) years of experience within the pharmaceutical industry.
• Experience working in an international, multicultural matrix organization.
• The presently-anticipated base compensation pay range for this position is $101,000 to $112,500. Nice to Have
• Role supporting seminars and courses are an asset. Compensation & Benefits
• Salary range: USD 101,000 - 112,500 per year.
• Annual Performance Bonus Plan.
• Benefits include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program.
• Paid time off benefits including vacation and sick time.
• At-will employment status; compensation programs subject to change per company policies.