Senior Quality Manager

Position Summary

Manage through subordinates the coordination of the activities both the Chemistry and Microbiology Laboratory. Responsible for results in terms of product quality and conformance to regulations and Baxter quality policies.

Job Responsibilities

• Manage the activities of the chemistry laboratory and process validation with responsibility for results in terms of product quality, performance and safety.
• Implements the quality systems procedures and manages compliance in a section or department.
• Understands and assures conformance to regulations in the Chemistry/Microbiology laboratory.
• Manage the activities of the microbiology laboratory with responsibility for results in terms of product quality, performance, and safety.
• Interfaces with regulators during regulatory inspections.
• May participate in or manage quality assessments of internal operations and suppliers to analyze compliance and assess risk.
• Interacts frequently with subordinate supervisors and functional peer group managers.
• Identifies and manages continuous improvement projects with the objective of achieving quality, reliability, and cost improvements.
• Coordinate and communicate with Lab Services and QA as required to maintain departmental operations.
• Advises on technical procedures, techniques, and equipment, and maintains conformance with specific operational standards.
• Maintains quality checks on the safety of laboratories and insures maintenance of the facilities according to good laboratory practices.
• Reviews testing and laboratory records for accuracy and compliance with cGMP and company policies and procedures.
• Maintains laboratory supplies inventory by checking stock to determine inventory level; anticipating needed supplies; placing and expediting orders for supplies; verifying receipt of supplies and approval of corresponding invoice.
• Oversees daily workflow of the department or direct reports.
• Develop and support career paths and professional growth opportunities for Quality Control staff that will provide continuous improvement in product quality and operations.
• Manage department to ensure timely release of products to meet company and customer quality requirements and timelines
• Following up on non-conformances, investigating corrective actions, and implementing appropriate corrective & preventative actions plans
• Develops budget for the department and ensures adherence to the budget.
• Manages the coaching, training and development process of subordinates.
• Sustain a clean and safe work area using 6S principles
• Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)

Knowledge, Skill and Abilities

• Thorough knowledge of applicable procedures, specifications, regulations and standards.
• Strong analytical and problem solving skills.
• Ability to manage/supervise a team of employees.
• Good communication and leadership skills.
• Good interpersonal/communication/influencing/negotiation skills.
• Good project management skills.
• Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
• Strong technical written skills