Quality Assurance Document Control Manager

Responsibilities: for the QADC Manager include: • 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 (QADC) 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. Required Qualifications for the QADC Manager include: • 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. Qualifications: for the QADC Manager include: • 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. Compensation: for the QADC Manager includes: • Salary Range: $95,000-100,000k annually based on experience • Full Benefits Package: PTO, Paid Holidays, Medical, Dental, Vision, 401K, Tuition Reimbursement, Paid Maternity Leave, Military Reserve Pay Offset This Job opens for applications on September 22, 2026. Applications for this job will be accepted for at least 30 days from the posting date. #LI-KP1 #LI-ONSITE #LI-KP1 #LI-ONSITE