Job Description

The Company:

Hugel America is a dynamic, growth-oriented subsidiary of Hugel Inc., a leading South Korean biopharmaceutical company. We are at the forefront of aesthetic medicine, specializing in the development and commercialization of cutting-edge products including:

Botulinum toxin
Hyaluronic acid fillers
Advanced aesthetic portfolio products

Our strategic focus encompasses key markets in:

United States
Canada
Australia
New Zealand

Position Summary:

The Senior Manager, Quality Systems and Compliance will support the development, execution and maintenance of the Quality and Risk Management systems, oversee Supplier Quality Management, and lead quality meetings with suppliers.

This role may be remote.

Responsibilities:

Manages Quality core processes; execution and maintenance of the Supplier Quality Management system for new and existing suppliers, including implementing processes to assess the quality and risk of the suppliers.
Provide quality oversight of GMP external manufacturing, testing and storage/distribution suppliers including establishment and maintenance of quality agreements.
Responsible for ensuring compliance with Hugel Quality and Regulatory requirements.
Establish, maintain and execute an audit schedule of current suppliers; plans, manages, and supports supplier audits.
Review and approval of manufacturing batch records, analytical records and technical documents, as well as preparation of batch documentation for disposition.
Lead quality meetings with suppliers.
Manages supplier quality related issues and facilitate the escalation of unresolved supplier quality issues.
Identifies nonconforming events, perform root cause analyses, and identify solutions with cross functional team.
Provide quality guidance and support for change controls, CAPAs and investigations.
Monitor performance metrics and drive continuous improvement.
Maintain current knowledge of industry standards and regulatory requirements for pharmaceutical quality management systems.
Support CMC regulatory filings for drug products.
Other related duties as assigned; provides additional support and assistance on tasks and projects as directed by management.

Requirements:

Bachelor’s degree.
7+ years’ experience in pharmaceutical/biotech industry, with 3+ years directly supporting GMP quality including supplier quality, CAPA and Risk Management.
Demonstrated experience managing GMP suppliers, including production of supplier metrics. Preferred experience performing supplier quality audits.
Understanding of, and ability to apply pharmaceutical/biotech cGMP regulations and guidance using a risk-based approach.
ASQ Audit Manager certification is a plus.
Critical thinking and problem-solving abilities.
Excellent decision making and leadership capabilities.
Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiency.
Effective communication and a reputation for integrity and ethical behavior are critical.
Strong interpersonal skills, a flexible, collaborative, and team-oriented approach to problem-solving, and an ability to work in a fast-paced, rapidly changing environment.
Bias towards start-up experience in a fast-paced environment!
Enjoy the creative process - you’ll be working in constant collaboration.
Exceptional organizational skills and detail oriented.
Strong written and verbal communicator with key decision makers.
Self-starter who is driven to address problems and produce solutions.
Growth mindset.
Ability to travel up to 20% (US and International), dictated by supplier audit and production schedules.

Physical Requirements:

Must be able to remain in a stationary position for long periods of time.
The person in this position needs to occasionally stoop, bend, and kneel.
Frequently moves materials weighing up to 25 lbs.
Must be able to travel approximately 10% of the time.

Job Type: Full-time

Pay: $70,000.00 - $110,000.00 per year

Application Question(s):

Can you demonstrate experience in managing GMP suppliers? Have you performed supplier quality audits?
Are you familiar with and able to apply pharmaceutical/biotech cGMP regulations and guidance using a risk-based approach?
Are you able to travel up to 20% of the time (both domestically and internationally) as dictated by supplier audit and production schedules?
Do you have experience in reviewing and approving manufacturing batch records, analytical records, and technical documents?

Education: