Senior GMDP Quality Assurance Manager

Location: Morrisville, North Carolina, US; hybrid, with willingness to work on-site five days per week if required. Candidates must reside in a U.S. state where the company is authorized to hire; residents of California, Colorado, New York, Washington, New Jersey, Massachusetts, Illinois, Hawaii, and the District of Columbia are not eligible.

Company

hirify.global provides clinical trial delivery, home health, expanded access, market access, and clinical trial supply solutions for biopharmaceutical sponsors.

What you will do

• Lead day-to-day site quality operations supporting distribution, manufacturing, secondary packaging, and labelling.
• Operate and continuously improve the site Quality Management System in accordance with GMP, GDP, and regulatory requirements.
• Monitor quality performance indicators, identify systemic risks, and drive corrective and improvement actions.
• Oversee deviations, complaints, CAPAs, change controls, investigations, root cause analyses, and product disposition.
• Lead inspection readiness, self-inspections, client and regulatory audits, audit responses, and remediation activities.
• Lead, coach, and manage the site QA operations team, including resourcing, training, succession planning, and technical development.

Requirements

• Bachelor’s degree or higher, preferably in pharmaceuticals, life sciences, or engineering.
• 7+ years of pharmaceutical or life sciences quality assurance experience across GMP and GDP operations.
• Senior leadership and people management experience, including cross-functional influence and risk-based decision-making.
• Experience with UK, FDA, and EU regulations for manufacturing and distribution.
• Applied knowledge of data integrity, label control, secondary packaging, deviations, change control, supplier and customer management, and QMS processes.
• Strong communication, organization, judgment, and Microsoft Outlook, Word, and Excel skills.

Culture & Benefits

• Medical, dental, and vision insurance, with FSA and HSA options.
• Short- and long-term disability, life, critical illness, hospital indemnity, and accident insurance.
• 401(k) safe harbor plan with company match.
• Paid vacation, holidays, sick and volunteer time, plus paid maternity and paternity leave.
• Wellness, professional development, team relationship, and inclusive workplace initiatives.

Hiring process

• Submit an English resume through the official careers portal or LinkedIn Easy Apply.
• An Upwage AI screener may be used as part of the application process, followed by contact from the hirify.global team for selected candidates.