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Senior Manager, Quality (Life Science Manufacturing)

RESPONSIBILITIES
• Develop strategic plan to ensure quality resources are adequate to support current and future business needs
• Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
• Manage a team of quality professionals to support product development and manufacturing operations:
o Provide quality leadership to design teams in the areas of design control, validation, and risk management
o Provide ongoing quality engineering support throughout the product life cycle
o Support development, engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs and requirements and ensure completeness of project transfer packages
o Review and approve manufacturing operational activities, such as Work Instructions, Device History Records, Non-conformance, CAPA, RMA, and customer complaints
o Drive product risk management activities and ensure risk files are updated as necessary
o Work with cross-functional teams to resolve operational quality issues
o Review and approve verification and validation protocols/reports. Develop and execute strategies to close gaps in an efficient, technical, and compliant manner
o Trend, analyze, and report on quality data to improve product and process; develop recommendations based on data analysis
• Train new engineers and/or associates
• Other such duties that may be determined by supervisor

REQUIREMENTS
• Bachelor’s degree in Chemistry/Biology/Life Sciences
• 10+ years in Manufacturing, Engineering, Quality in a regulated environment.
• Experienced in process/system validation, new product introduction, quality management system, and continuous improvement methods.
• Excellent interpersonal, verbal and written communication skills.
• Excellent Knowledge and working application of 21 CFR 820 and ISO 13485 requirements
• Ability to manage a team of working professionals to achieve and maintain department goals
• Ability to multi-task and methodically manage projects in a fast-paced manufacturing environment.
• Ability to communicate effectively across functions and organizational levels.
• Intermediate to advanced experience with words processing and spreadsheets, charting, graphing tools and presentation tools.
• Experience in failure investigation, technical report writing, data mining, trend analysis and statistical analysis
• Strong analytical, problem-solving and decision-making skills; Certified Quality Engineer, or equivalent, is a plus
• Familiar with statistical analysis packages, eg, JMP, Minitab.

EA License no: 16S8066 | Registration no: R1550486

Only successful candidates will be notified.
To apply, please email your CV to ewenp@charterhouse.com.sg. If you would like further information, please contact Ewen Poh on +65 6435 5616 quoting HC&LS/EP/SMQ/240518C
or complete the Application form below.
Application for Senior Manager, Quality (Life Science Manufacturing)

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