Quality Manager (US-based role)

GENERAL RESPONSIBILITIES:

• Direct the Quality Assurance department in the development/revision and implementation of Standard Operating Procedures (SOPs) as
• Ensure compliance (GMP, GXP) with appropriate SOP’s according to US FDA and ICH
• Head up the organization’s Quality
• Contract manufacturer, packager, and analytical lab
• Batch release, product complaints, distribution records
• Change control administration and management as well as responsibility for the company’s overall document control
• Vendor
• Complaints and investigation systems
• Ensure FDA and cGMP compliance across the

 

SKILLS AND QUALIFICATIONS:

• Proven Quality leader with 5-10 years experience in the pharmaceutical or healthcare related
• 1-2+ years effectively managing and leading teams.
• Bachelor’s degree in biological or health An advanced or additional business degree is an asset.
• Strong management and leadership skills along with strategic thinking ability and a proven track record of FDA and cGMP
• Self-motivated with a high degree of initiative and sense of
• Ability to work independently, prioritizes multiple projects, addresses multiple issues, and handles multiple deadlines, in a hands-on
• Inter-dependent partnering skills, team-orientation and demonstrated ability to influence outcomes
• Solid decision-making
• Excellent communications skills (verbal, written, listening, conveying messages) with strategizing and negotiating
• Experience in working with MS