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Hatch Pros · 14 hours ago

GMP Operational Quality Senior Manager

Boston, MA

Contract

Onsite

Senior Level

$70/hr - $70/hr

6+ years exp

Hatch Pros is looking for a GMP Operational Quality Senior Manager to backfill a 6-month contract. The role requires strong leadership in GMP requirements and quality management while overseeing event investigations and CAPA processes.

Information Technology & Services

No H1B

Responsibilities

Backfill a 6-month contract in Boston, MA

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

Qualification

GMP requirements experienceRoot Cause Analysis (RCA)Project managementElectronic document management systemsTeam leadershipMentoring skillsCommunication skillsDecision-making

Required

Bachelor's degree

6 years of experience working with GMP requirements and support of GMP manufacturing

Strong team leadership skills