Biotech QA Leader - Regulatory Compliance & QA Oversight

Piper Companies; Elkridge (MD); On-site; USD 115,000 - 135,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Sick leave

Job summary

Piper Companies is seeking a Quality Assurance Manager for a biotechnology company in Elkridge, MD. The role leads QA and document control, supports regulatory readiness, and ensures compliance with cGMP, FDA, and QMS.

You will manage audits, CAPAs, deviations, change controls, and batch release activities, while developing metrics and cross-functional quality initiatives.

Requirements include a science degree, 8+ years in GMP, MasterControl experience, strong writing and leadership skills.

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent.
• 8+ years of GMP-regulated experience.
• Experience in FDA-regulated environments with regulatory inspections.
• Strong knowledge of cGMP, US/EU standards.
• Experience with document control systems (MasterControl preferred).
• Excellent written and verbal communication, organization, and problem-solving skills.

Responsibilities

• Manage daily QA and Document Control operations.
• Review, approve, and maintain quality documentation (deviations, CAPAs, change controls, investigations).
• Lead regulatory inspections and internal/supplier audits; support audit readiness.
• Oversee document control and eDMS administration.
• Manage product and supplier complaints, adverse events, and risk assessments.
• Provide QA oversight of manufacturing activities (batch release, BR review).
• Ensure compliance with cGMP, FDA regulations, SOPs, and QMS.
• Develop quality metrics and KPIs; drive process improvements.
• Review QC testing data and support material release.
• Provide QA and eDMS training to internal and external users.

Skills

Leadership experience

Technical writing

Communication skills

Problem-solving

Quality systems

GMP knowledge

Education

Bachelor's degree in science

Associate degree with relevant experience

Tools

MasterControl

Job description

Piper Companies is seeking a Quality Assurance Manager for a biotechnology company in Elkridge, MD. The role leads QA and document control, supports regulatory readiness, and ensures compliance with cGMP, FDA, and QMS.

You will manage audits, CAPAs, deviations, change controls, and batch release activities, while developing metrics and cross-functional quality initiatives.

Requirements include a science degree, 8+ years in GMP, MasterControl experience, strong writing and leadership skills.