Director, Quality Management Systems/Validation & Compliance Lead (Pharmaceutical)

Location: Hybrid, Groton, Connecticut, United States. Candidates must have permanent authorization to work in the U.S.; U.S. work visa sponsorship is not available. Periodic travel, after-hours or weekend response, and emergency or off-shift site support may be required.

Annual base salary: $162,900–$271,500, plus a 20% bonus target and eligibility for a share-based long-term incentive program.

Company

hirify.global is a global pharmaceutical company developing medicines and conducting research across regulated laboratory and clinical environments.

What you will do

• Drive the GWE R&D Compliance Program and quality management systems across global sites.
• Lead the design, deployment, training, documentation, and continuous improvement of compliance program elements.
• Oversee validation, documentation, training, audits, corrective actions, and compliance with cGLP, cGCP, cGMP, and other non-EHS regulations.
• Manage risk reviews, certification and registration efforts, quality reviews, and compliance effectiveness reporting.
• Develop strategies, policies, objectives, status reports, and presentations for R&D leadership.
• Collaborate with GWE colleagues, R&D units, contractors, vendors, strategic partners, customers, and third-party assessors.

Requirements

• Bachelor’s degree in a relevant discipline and 8+ years of relevant experience.
• Experience in facility management, engineering, or pharmaceutical compliance; 15 years is preferred.
• Detailed knowledge of facility management, quality management systems, and GLPs, GCPs, and GMPs.
• Experience implementing and maintaining quality systems such as ISO 9000 or Malcolm Baldrige; technical records and Six Sigma experience are advantageous.
• Proven financial management, analytical, cost-saving, business continuity, and strategy implementation skills.
• Strong leadership, communication, facilitation, collaboration, and senior stakeholder influence capabilities.

Nice to have

• Master’s degree in a relevant discipline.
• Experience developing and training staff and managing multidisciplinary teams.
• Knowledge of GWE business functions or pharmaceutical R&D operations.

Culture & Benefits

• Hybrid work arrangement with access to laboratory, GxP aseptic, utilities, maintenance, and other facility environments.
• 401(k) plan with hirify.global matching and additional retirement savings contributions.
• Paid vacation, holidays, personal days, caregiver/parental leave, and medical leave.
• Medical, prescription drug, dental, and vision coverage.
• Relocation assistance may be available based on business needs and eligibility.