GMP Operational Quality Senior Manager

This range is provided by Hatch Pros. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$70.00/hr - $70.00/hr

Notes: no H1B visas, need genuine candidates, two recent work references required upon submission.

Work schedule:

Sunday–Wednesday, 7:00 AM–5:30 PM; at least 3 days per week onsite, likely 100% during the first few weeks.

• Bachelor's degree
• 6 years of experience working with GMP requirements and support of GMP manufacturing
• Strong team leadership skills
• Strong experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
• Strong experience with electronic document management systems (QDoccs, Trackwise, Veeva)
• Experience authoring and enforcing Agreements between CMOs/Suppliers and the Company
• Investigation and CAPA approval experience
• Experience conducting GMP document review, including procedures, work instructions, specifications, methods, protocols, and method reports
• Ability to work in a fast-paced environment
• In-depth experience leading complex projects/teams Strong project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks
• Ability to independently lead cross-functional teams and represent the Quality unit
• Ability to mentor and guide staff, skilled at transferring technical knowledge and teaching quality management skills
• Ability to communicate cross-functionally to a wide variety of audiences
• Demonstrated ability to manage teams and to develop personnel
• Demonstrated ability to evaluate quality matters and make complex decisions

Mid-Senior level

Contract

Quality Assurance