QA Compliance and System Manager

1 week ago

Singapore Thermo Fisher Scientific Full time

**Key Responsibilities**:
**Proactive Quality Assurance**:Ensures compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements, establishing, and maintaining Quality systems. Manages staff that performs the following functions: Reporting, tracking and trending site Key Performance Indicators; Review and Assessment of Corporate Standards; Annual Product Review; Data Integrity; Quality Risk Management; and, Quality Project Management.

Additional responsibilities include Special Regulatory Compliance Projects like Data Integrity (DI) and Continued Process Verification (CPV). Proactive Quality will also support the deployment and management of the Electronic Document Management System (Documentum) and Electronic Quality Management System (Track Wise®).

**Validation Quality Assurance**:Implements the overall quality strategy for the Greenville facility with respect to validation. Oversees all aspects of QA Validation operations within the facility, including but not limited to executed equipment and instrument validation, method validation, data integrity, computer systems validation, deviation investigations, change controls, customer quality support and SOP review.

**Document Control & Change Management**:Provides oversight and execution of creation, routing, approval and issuance of critical documents and records that support all phases of product operations. Leads team coordinating change controls with customers and ensure documentation/record changes are approved by customers per quality agreements.

Quality Audit and Regulatory Inspection: Leads team that ensures that that site remains client audit and regulatory inspection ready at all times. Ensures that internal audit program is robust and appropriate to identify areas of improvement including the development of suitable corrective and preventative actions. Coordinates review and response to observations including the development of suitable corrective and preventative actions. Maintains audit and inspection schedule. Reviews and reports findings to site leadership. Tracks and reports regulatory industry trends with respect to regulatory compliance.

**Job Scope**:Provides tactical direction and immediate supervision to a group of employees by assigning tasks, checking work, and maintaining schedules. Erroneous decisions or failure to achieve results will add to costs and may impact the short-term and long-term goals of the company.

**Supervision**:Provides direct supervision and may assist with the work as demands dictate.

**Minimum Requirements/Qualifications**:
**Education**:Bachelor’s degree required in a scientific or related field is preferred.

**Experience**:Ten or more years of experience in the pharmaceutical industry that includes five years supervisory experience, is preferred.

**Equivalency**:Equivalent combinations of education, training, and relevant work experience may be considered.

**Other Job Requirements**:
Outstanding attention to detail and organizational skills. Self-starter, mature, independent and dependable. Ability to work in a fast-paced environment under pressure, able to multi-task and is results-oriented. Demonstrates ability to maintain a high degree of confidentiality. Effective time management and prioritization skills. Requires discretion and independent judgment. Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters. Highly effective verbal and written communication skills. Demonstrated ability to manage and lead professional staff in order to achieve goals, evaluate and resolve complex technical problems. Ability to motivate, energize, and retain key staff by direct interactions with supervisors and staff.

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