Sr. Manager QA Drug Product (Filling)

About the role

This role is responsible for quality floor oversight of the filling (i.e. equipment prep, formulation, and filling) operations for SA12.

Responsibilities

• Provide leadership to multiple teams under your supervision, including being responsible for
  • Quality oversight of all equipment prep, formulation, and filling (multiple lines)
  • Responsible for programs that support the department, for example: area walkthroughs
  • Support development and growth of team, including your people leaders
  • Leadership point of contact for escalation of events, process updates, etc.

Requirements

• Proven leadership in cGMP environments, including experience speaking and preparing for regulatory inspections and audits.
• Strong collaboration and communication cross-functionally
• Ability to think critically, and continuously improve processes
• Ability to lead a department through a fast-paced and dynamic environment

Qualifications

• Proven experience in fill/finish manufacturing is preferred.
• Previous supervisory/ people leadership experience is required.
• May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

Benefits

Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)

Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

Full-time, Monday-Friday, 8am-4:30pm