Senior Manager, Quality Assurance

The Senior Manager, Quality Assurance is responsible for leading and managing the Quality Assurance team and activities, management of the internal/external audit programs, Supplier Quality Management, Annual Product Review, Quality Agreements, management of the batch record pre and post review process, review of Validation Protocols and Reports, and resolution of customer quality issues.

The Senior Manager is responsible for contact with QA internal and external customers regarding quality issues related to documentation, inspection, receiving, manufacturing/packaging and distribution processes. This role will serve as a subject matter expert and will ensure that their team is trained and operates compliantly with applicable SOPs, internal processes and regulations.

Essential Duties and Responsibilities

• Provide leadership, guidance and direction for the Quality Assurance team.
• Oversee the key quality processes that impact/relate to product compliance including batch record review and product release, compliance in movement and storage of materials, Investigations, and CAPAs as related to product compliance.
• Develop and implement quality assurance policies and procedures.
• Track, monitor and analyze key performance indicators (KPIs). Present KPIs to appropriate members of site leadership on a regular basis.
• Responsible for the management of the batch record pre and post review processes

-including providing oversight of master batch record issuance and batch release processes for Manufacturing and Packaging

• Responsible for negotiation and approval of customer Quality Agreements
• Interact with customers as needed for collaboration, problem-solving, and standard meetings
• Responsible for providing continuous oversight and management of Supplier/Vendor Quality Management programs, audit programs and Annual Product Reviews (APRs) to assure compliance with company policies, cGMPs and other applicable regulatory requirements.
• Provide guidance and assist in appropriate problem-solving initiatives to address customer or regulatory quality issues.
• Ensure processes needed for the Quality Management System are documented.
• Ensure the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
• Troubleshoot and direct the resolution of Quality issues related to Packaging and Manufacturing by fostering effective interdepartmental and cross-functional partnerships.
• Develop and maintain KPIs for batch record review right first time and error tracking.
• Oversee the clinical label release and issuance processes to ensure that quality and compliance standards are met.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Bachelor’s Degree in a science or technical field
• Master’s Degree in a science or technical field, preferred but not required.
• A minimum of 8 years’ experience in a regulated pharmaceutical or biopharmaceutical industry
• Leadership experience in a QA, laboratory or production environment required, including a demonstrated ability to identify problems, make decisions, and initiate successful corrective actions.
• Quality Assurance experience in an operational or development setting with demonstrated knowledge of techniques for assessing the quality of processes and the ability to guide others in these activities.
• Advanced knowledge of GMPs, GCPs, ISO and other applicable regulatory requirements for pharmaceuticals and medical devices and the ability to communicate this knowledge to the entire organization professionally and succinctly.
• Strong understanding of and experience supporting functional areas of business, including but not limited to, validation, manufacturing, materials management, laboratory operations, and workforce planning.