Senior Manager, Quality

3 days ago

Singapore Thermo Fisher Scientific Full time

**How Will You Make an Impact?**

As part of the Thermo Fisher Scientific team, you will conduct vital work. You'll have all the resources and support you need to reach your goals with your collaborators around you. We have a well-developed plan that's likely to thrive in the near term and perhaps well into the future. Put your skills to work for our organization, and you will make an impact on the world.

**What will you do?**

This position reports directly to the Director of Quality at Singapore and will manage the Gul Circle Quality organization to achieve Quality objectives and assure compliance with industry standards.
- Ensure excellence and compliance in product lifecycle management
- Ensure Corporate, Regulatory, Quality requirements are met
- Ensure that customer expectations are met or exceeded

**Key Duties and Responsibilities**
- Support and provide expertise to the Quality Management System (QMS) and Quality department to successfully meet or exceed goals and targets
- Collaborate with the various functions and legal manufacturer to ensure the quality management system is comprehensive, incorporates best practices, and is consistent with the strategic plan
- Product Manufacturing and Laboratory Quality Assurance and Control responsibilities including quality of design transfer, risk management, document control and record management, and supplier management
- Manufacturing responsibilities including batch record, training, process controls, labeling, change management, investigation of complaints stemming from Gul Circle manufacturing, and CAPA
- Responsible for monitoring and measurement including validations, calibrations, customer feedback and complaints, quality manual, internal audits
- Responsible for all MA/RH quality metrics and reporting for monthly and quarterly business reviews - Product Complaint rates, Cost of the Poor Quality, Customer support satisfaction
- Support and provide quality expertise to the business process transfer activities
- Hire and retain a diverse, highly qualified staff and provides ongoing performance feedback. Set goals which align to department plans and manage the execution of goals through coaching and mentoring
- Ensure continuous improvement through the Practical Process Improvement (PPI)
- Install and maintain a quality culture

**How will you get here?**

**Education**
- Bachelor of Science Degree in - Life Sciences, Engineering or related science/engineering degree preferred

**Experience**
- 10+ years of professional quality experience - quality leadership experience preferred
- Experience in Chromatography and/or microarrays is desired

**Knowledge, Skills, Abilities**
- Understanding of the pharmaceutical and biopharmaceutical industry and required compliance regulations for Analytical Scientific products and processes
- Expert working knowledge and experience with ISO 9001 and ISO 13485
- Experience in MDSAP, IVD/IVDR, and GxP requirements preferred
- Ability to travel domestically and internationally - up to 15%
- Expert knowledge and experience implementing the following:

- Advance Product Quality Planning (APQP)
- Design and Process FMEA’s (Failure Mode Effects Analysis)
- Global CAPA (Corrective and Preventive Actions) process
- NPI (New Product Introduction) process

**Desired Qualifications**:

- Contributes as a valued team member and colleague with leaders at all levels
- Experience working and providing customer support, investigations, and relationship management
- Proven communication and customer management skills
- Experience supporting change management efforts
- Proven people management skills
- Demonstrates personal awareness and desire for continual learning and personal development
- Hands-on and action oriented - Normally receives little instruction on day-to-day work, general instructions on new assignments
- Must possess the presentation skills and professionalism to project a professional image, both internally and externally
- Strong interpersonal, verbal and written communications skills are essential

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