Quality Assurance Document Control Manager

Piper Companies is seeking a Quality Assurance Document Control (QADC) Manager to support a rapidly growing biotechnology and pharmaceutical manufacturing organization. The role is onsite in Elkridge, MD, with occasional travel to a nearby facility.

Responsibilities

• Develop and implement document control policies and procedures to ensure compliance with cGMP, FDA, and regulatory requirements.
• Manage daily operations of the Quality Assurance Document Control team and provide leadership to subordinate staff.
• Administer and maintain the Electronic Document Management System (eDMS), including document workflows, training, and change control processes.
• Review, approve, and quality‑check SOPs, protocols, policies, forms, and other GMP documents for accuracy and compliance.
• Collaborate with Manufacturing, Validation, Quality Control, Facilities, and other cross‑functional teams to support quality system initiatives.
• Support internal and external audits, inspections, and regulatory submissions by providing and managing required documentation.
• Track quality metrics and KPIs, identify process improvement opportunities, and drive continuous improvement initiatives.

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent combination of education and industry experience.
• 8+ years of experience in a GMP‑regulated pharmaceutical, biotechnology, or related manufacturing environment.
• Experience working in an FDA‑regulated environment with strong knowledge of cGMP regulations and quality systems.
• Hands‑on experience with electronic document management systems (eDMS); MasterControl experience preferred.
• Strong technical writing, document review, and document control experience.
• Previous leadership or people‑management experience overseeing document control or quality personnel.
• Proficiency with Microsoft Office Suite and Adobe Acrobat, along with excellent communication and organizational skills.

Pay

Salary Range: $95,000‑100,000 annually, based on experience.

Benefits

• PTO and paid holidays
• Medical, dental, and vision insurance
• 401(k) retirement plan
• Tuition reimbursement
• Paid maternity leave
• Military reserve pay offset