Manager, Quality
Singapore, Singapore
Job Description
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Summary of position:
Reporting to the Director of Quality for the Single Use Technologies unit this role will be responsible for the overall quality management system at Joo Koon Circle Site. This position will hire, develop, and lead quality personnel to achieve Quality objectives and ensure compliance with industry standards and customer expectations for Single Use Technology products.
The person in this role will determine, organize and apply necessary resources to meet identified Quality initiatives and ensure that Corporate, Regulatory, Quality requirements are met. As the Quality site leader, the role will also focus on ensuring that staff engagement is maintained at a high level through development planning, Gemba, skip level and 1:1 meetings. The role will also collaborate with other Quality site heads within BPD on division-wide initiatives that are focused on enhancements to the quality system in order to meet expectations placed on our customers and ensure harmonization of processes so that the customer experience is the same across all products.
Responsibilities:
- Function as Management Representative under applicable standards.
- Responsible for working with Site Leadership Team to deliver on site goals and objectives
- Collaborate with the various functions to ensure the quality management system is comprehensive, incorporates best practices, and is consistent with the strategic plan.
- Support and provide expertise to the Quality Management System (QMS) and Quality department to successfully meet or exceed goals and targets
- Educate and mentors employees on the site QMS and other quality/operational programs and processes
- Provide the necessary leadership and strategic planning to develop, implement and maintain a quality assurance and quality control program to support the business mission and ongoing continuous improvement effort.
- Formulates and oversees maintenance of quality control objectives and coordination with production procedures to maximize product quality.
- Instill and maintain a quality culture.
- Provide input and direction to resolve quality related issues through proper inspections, root cause analysis and corrective actions plans.
- Apply quality risk management in order to facilitate a culture of risk identifiers.
- Ensure CAPA\xe2\x80\x99s are effective and closed in a timely manner.
- Ensure continuous improvement through Practical Process Improvement (PPI).
- Serves as key member of product teams, with focus on quality planning for new products/processes.
- Monitors quality performance for the Logan site, reports progress, and keeps leadership informed of progress, issues, corrective action, and customer complaints.
- Provide direction to ensure compliance with all applicable customer requirements and government regulations involving product quality.
Desired Qualifications:
- Proven communication and customer management skills
- Hands on knowledge of products and applications
- Understands the BioProduction customer and required compliance regulations for our products and processes
- Experience working and providing customer support, investigations, and relationship management
- Must model the highest degree of moral and ethical behavior
- Must maintain confidential information
- Experience working successfully in a fast-paced environment
- Experience supporting change management efforts
- Proactive and takes ownership for producing positive results
- Contributes as a valued team member and colleague with leaders at all levels
- Demonstrates personal awareness and desire for continual learning and personal development
- Keeps commitments; exhibits candor and courage - is not afraid to establish a visible presence and point of view, to engage in spirited and constructive debate, to hold others accountable
- 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.
Required Qualifications:
- Bachelor\xe2\x80\x99s degree from an accredited higher learning institution
- 10+ years Quality experience
- Excellent knowledge of ISO 13485:2016
- Has worked in a regulated manufacturing and/or production environment
- Good understanding of cGxP, customers, products, and regulatory compliance
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Job Detail
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Job IdJD1293134
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationSingapore, Singapore
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EducationNot mentioned