Quality Assurance Manager

Piper Companies is currently looking for an experienced Quality Assurance Manager in Elkridge, Maryland (MD) to work for an innovative and growing pharmaceutical company.

• Manage a team of quality assurance professionals within a GDA/GMP Pharmaceutical manufacturing environment.
• Follow Policies and SOPs to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests.
• Serves as the Electronic Document Management System (eDMS) administrator, maintains and implements eDMS processes; partners with Validation to manage/maintain change control and validation documentation for eDMS.
• Coordinate with document originators and/or stakeholders to resolve document control issues to obtain final approval/ensure smooth operation of all functions.
• Manage the organization of controlled document files within the Document Control center and ensure that records are readily retrievable.
• Ensure all controlled documents follow regulatory requirements, including FDA and international guidelines.
• Maintain employee training records, document master files, authorized signature forms according to company procedures, industry best practices, and government regulations.
• Carry out a variety of activities to support manufacturing operations becoming familiar with site processes, procedures, and policies as individual develops knowledge aligned with cGMPs and Health Authority regulations.
• Review and approval of qualification activities, quality records like deviations OOS, complaints, auxiliary forms, investigations, procedures and other quality related documentation.

• A minimum of 8+ years of work experience within FDA/GMP regulated manufacturing environments
• Hands on leadership experience within pharmaceutical quality assurance
• In-depth knowledge of cGMP and regulatory requirements (US and EU) applicable to the pharmaceutical, biotechnology, or related industries.
• Bachelor’s or higher degree within in Scientific field

• Salary Range is $115,000 – $135,000 dependent upon experience
• Comprehensive benefits package

Pharmaceutical Manufacturing, QA, Quality Assurance, Manager, Leadership, FDA, Science, comprehensive benefits package, Health, Vision, Dental #LI-ONSITE #LI-DF1