Quality Assurance Manager Jobs

Quality Assurance Manager

Our client is a fast growing Global Pharmaceutical Manufacturing Company and they have an immediate opening for a Quality Assurance Manager to join their team! They offer a very competitive compensation and benefits package as well as an extremely friendly and collaborative work environment.

The QA Manager provides leadership and guidance for the department, works to improve core processes, and manage projects. Ensure the staff is qualified in all quality area functions and that the QMS is maintained to applicable GMP requirements.

• Conducts performance and development reviews
• Ensures QA documentation and batch release is completed by due dates and project timeline.
• Support the Quality teams in regard to projects including but not limited to commercial and clinical batches, Operational, QC, and QMS projects
• Continuously monitors and reviews QA systems and procedures for adherence to regulatory compliance, quality improvements, efficiency and industry best practice
• Exhibit strong communication and problem solving skills while leading the Quality Assurance department toward company goals and objectives.
• Effectively lead team to deliver goals/results. Provides coaching and the necessary resources to area management to meet department objectives
• Provides direction and leadership for the QA team in compliance, systems, commercial, pre commercial processes, support for development, manufacturing and supply chain operations.
• Leads the design, implementation and continuous improvement of QA Operations, Systems and Compliance to promote efficient and compliant operations
• Maintains tracking mechanisms to support various QA related metrics
• Maintain an electronic documentation control system assuring all documents are current. Act as the Ensur system administrator.
• Provides support for implementation of new and key process optimization.
• Lead and support with customer requests, quality events, QTAs, and complaints.
• Identify areas of continuous improvement within the Quality department and in the Quality Management System.
• Develop and perform training for the Quality team as well as other departments in areas of the QMS and GMP requirements.
• Support the teams as the system SME and/or administrator for creating CAPAs, change controls, deviations, and laboratory investigations.
• Provides compliance support and expertise for QA department
• Provide guidance and leadership to the QA Specialists with input into their performance and goals
• Participates in site quality and process improvement initiatives. Represents QA on site project teams
• Develops and manages daily work schedule for QA Specialists to meet QA deliveries schedules and needs.
• Conducts interviews and hires qualified candidates to fill open technical and support positions
• Supports the execution of audit readiness program to ensure compliance ready state at all time to Customer and Regulatory audits.
• Evaluate metrics for trends to better focus on areas requiring improvement. Develop goals for the Quality Assurance team to drive improvement and monitor for effectiveness.

QUALIFICATIONS

• Proficient computer skills, such as Microsoft Office, including Teams
• Bachelor degree or higher in relevant scientific quality assurance/technical field and 5 years’ experience in a Pharmaceutical Manufacturing environment
• 7+ years experience in a Pharmaceutical Manufacturing Quality Assurance role.
• Good written, verbal and interpersonal communication skills
• Leadership skills: Building the best team; business insight; strategic mindset; problem-solving; resource management
• Ability to organize time for multiple tasks (major projects and daily functions)