QA Manager

About the role

Quality Assurance is a support group to the Operational Departments of Manufacturing, Quality Control, Warehouse, and Facilities. The Quality Assurance Manager is responsible for managing daily operations of the QA staff, performing technical functions in the Quality Assurance group, and interacting with each group to ensure accurate and compliant documents are produced and release of intermediates and final product. This role ensures compliance of SOPs, policies, forms, and procedures.

Responsibilities

• Manage subordinate staff in the day-to-day performance of their jobs.
• Assist Quality Assurance Management in daily operations.
• Quality check all documents for conformance to plans and EDMS requirements.
• Verify the accuracy and completeness of cGMP documents.
• Follow Policies and SOPs to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests.
• Serve as the Electronic Document Management System (eDMS) administrator, maintain and implement eDMS processes; partner 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 and 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 aligned with cGMPs and Health Authority regulations.
• Review and approve qualification activities, quality records like deviations, OOS, complaints, auxiliary forms, investigations, procedures, and other quality-related documentation.
• Create and maintain risk assessments to ensure program/project risks are identified, assessed, mitigated, and closed.
• Perform technical review of Quality Control testing data against established specifications.
• Assist with the receipt and processing of Supplier Change Notifications.
• Manage the receipt, investigation, and closure of product complaints, supplier complaints, and adverse events.
• Manage timely review and release of raw materials and consumables to maintain the production schedule.
• Perform QA on the Floor activities, including room release, observing critical processes, reviewing batch documentation in real time, cleaning documentation, logbooks, and resolving issues that occur during manufacturing.
• Schedule, plan, conduct, and compile detailed reports for internal and supplier audits.
• Ensure adherence to cGMP and other relevant regulatory requirements throughout the batch record review process.
• Work directly with all departments to provide process oversight and support compliance.
• Investigate discrepancies identified and review quality records (deviations, CAPAs, change controls, out of specifications), collaborating with relevant departments to address and resolve issues promptly.
• Identify opportunities for process improvements and contribute/lead development and implementation of enhancements.
• Organize timelines, schedules, and resources to ensure project milestones are met.
• Conduct risk-based investigations using problem-solving tools.
• Author, review, and approve data/documents such as methods, procedures, policies, and/or protocols.
• Oversee development and tracking of metrics/KPIs for quality activities.
• Provide training/presentations as needed.
• Conduct scheduled, structured training for all users of the eDMS, both internally and externally.
• Conduct Quality-focused training sessions to educate team members on quality programs, documents, and best practices.
• Support regulatory readiness of the organization and participate in regulatory audits and inspections.
• Assist in audit preparation.
• Communicate and coordinate with other departments to ensure training and quality compliance.
• Remain familiar with the day-to-day activities, personnel, and issues within the facilities.
• Stay current with the latest industry trends, tools, and best practices, bringing forth new ideas and challenging the status quo.
• Perform other related duties as required and/or assigned.

Requirements

• Bachelor’s degree in a relevant scientific discipline or equivalent work experience.
• In-depth knowledge of cGMP and regulatory requirements (US and EU) applicable to the pharmaceutical, biotechnology, or related industries.
• Experience working in an FDA-regulated environment required.
• Experience with regulatory inspections required.
• 8+ years’ experience in a related GMP environment.

Skills

• Proficient knowledge of document control electronic systems (MasterControl preferred).
• Strong knowledge of Microsoft Word, Excel, Outlook, PowerPoint, Access, and Adobe Acrobat.
• Strong technical writing and editing skills.
• Strong organization, presentation, and facilitation skills while paying attention to detail.
• Strong people management skills.
• Excellent verbal and written communication skills.
• Ability to work independently and in cross-functional teams in a collaborative manner.
• Knowledge and experience with cGMP practices.
• Thorough knowledge and understanding of quality systems.
• Ability to lead project teams and work collaboratively to drive right-first-time initiatives.
• Ability to work in a dynamic and fast-paced environment.
• Ability to gown into clean rooms including ISO 5.

Schedule

Monday through Friday – 8:00 AM to 4:30 PM (with 30-minute lunch) or 8:00 AM to 5:00 PM (with 1-hour lunch).

Location

This is an onsite position at our Elkridge, MD site with travel to the Seton facility (20 minutes north) as needed.

Benefits

• Competitive salaries
• Outstanding comprehensive benefits
• Employee Stock Options