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