Manager, Quality Assurance (Biotech)

Location: Concord, MA, Boston Metro only; onsite at least four days per week and must be able to work from the Concord office.

Base compensation: $140,000–$160,000 per year.

Company

hirify.global develops and supports therapeutic products in the biotech and pharmaceutical sector.

What you will do

• Oversee daily product quality complaint activities, including intake, triage, investigation coordination, follow-up, reconciliation, and file closure.
• Own and mature the US product quality complaints process, procedures, documentation, and related training.
• Coordinate notifications and collaboration with pharmacovigilance, Medical Information, Quality leadership, manufacturing sites, vendors, and other partners.
• Review social and traditional media reports, manage complaint trends and performance indicators, and escalate emerging issues.
• Present complaints during audits and inspections and own responses, mitigation, and process improvements.
• Manage vendor relationships and ensure appropriate complaint language is included in contracts and purchase orders.

Requirements

• 5+ years of progressive experience in Quality or Product Quality Complaints within the biotech and/or pharmaceutical industry.
• Strong foundation in FDA requirements and progressive experience with international regulations.
• Experience coordinating investigations, complaint documentation, notifications, reconciliations, and regulatory compliance activities.
• Ability to manage multiple priorities with consistent focus on compliance, detail, and patient safety.
• Must be able and willing to work onsite in Concord, Massachusetts at least four days per week.

Nice to have

• Bachelor’s degree in a STEM field.
• Experience with the US FDA and international regulatory bodies, including EMA or MHRA.
• Experience working in a fast-paced, globally matrixed environment.
• Experience initiating and leading department initiatives.
• Strategic communication skills for engaging Quality leadership, stakeholders, and external partners.

Culture & Benefits

• Work within a fast-paced, growing Quality organization.
• Collaborate with global and local Quality teams, internal stakeholders, and external vendors.
• Support product quality and patient safety through compliant, data-driven processes.