Quality Manager (USA)

Location: USA based

Key Responsibilities

Quality Assurance:

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

Skills and Qualifications:

• Proven Quality leader with 5-10 years experience in the pharmaceutical or healthcare related industry.
• 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 compliance.
• Self-motivated with a high degree of initiative and sense of urgency.
• Ability to work independently, prioritizes multiple projects, addresses multiple issues, and handles multiple deadlines, in a hands-on environment.
• Inter-dependent partnering skills, team-orientation and demonstrated ability to influence outcomes.
• Solid decision-making skills.
• Excellent communications skills (verbal, written, listening, conveying messages) with strategizing and negotiating strengths.
• Experience in working with MS office.