The Manager, Manufacturing Quality is a key member of the Quality Assurance Organization. The role is dedicated to supporting Manufacturing and Product Quality activities. The individual is responsible for driving change, addressing product quality concerns, and collaborating on process excellence initiatives. A solid understanding of regulatory requirements for products and processes as it pertains to ISO 13485, 21 CFR 820, 21 CFR 809, ISO 14971, and EU IVDR. The prospective candidate will support a dynamic, fast paced organization for both new product development core teams, supply chain, production, and technology transfer. This individual will have direct interaction with Manufacturing, Engineering (Automation), Process Development, Supply Chain, Facilities, Quality Control, Program Management Office, and Regulatory Affairs. The individual will also be a key member on the New Product Introduction Core Team representing Quality Assurance. The position will be responsible for collaboration of the risk management activities and support development of process/process/equipment validation strategies during technology transfer of new product to the sustaining team.
Key Tasks and Responsibilities:
- Complies with departmental procedures and policies and appropriate Quality policies.
- Recognizes ISO 13485 and EU IVDR requirements and ensure we are compliant.
- Direct technical and compliance support for high through put for Synthetic Biology (Reagents, NGS Kits, NGS TE Panels, Gene production, etc.) manufacturing.
- Provides strategic solutions throughout the manufacturing product lifecycle, ie, raw material, sampling plans, suppliers, inspection, OEM, change control, process and product validations, stability, testing, and batch release.
- Partner and collaborate with manufacturing support functions such as Calibration, Preventive Maintenance, Facilities, and Environmental Monitoring to meet and improve compliance and manufacturing needs.
- Collaborates and engages with Technology Transfer on New Product Introduction to understand and support needs.
- Provide support to development, engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs and requirements.
- QA representative on New Product Introduction Core Team Meeting (CTM).
- Aides in the assessment and qualification of new supplier materials such as component specifications and inspection standards.
- Drive process risk management activities and ensure quality and completeness of validation packages and change orders.
- Ensures adequacy of complaint, non-conformances and CAPA records, investigations, and corrective actions.
- Ability to effectively generate and maintain various KPIs and develop recommendations based on data analysis.
- Ensure manufacturing processes and validation programs meet requirements of FDA and ISO.
- Directly support IVD/IVDR Implementation within manufacturing.
- Support QMS elements such as, but no limited too; Product Risk management, Post Market Surveillance, Deviations, and Customer complaints.
- Trend, analyze, and report on quality data to improve product and processes; develop recommendations based on data analysis.
- Demonstrates effective communication style working with all levels of organizational structure, through multiple departments, and across global sites.
- Effectively influences and trains employees (as required).
- Maintains strong communication network with peers.
- Embrace and execute process improvement initiatives of varying complexity engaging cross-functional support.
- Demonstrate effective knowledge and use of various computer systems.
- Additional responsibilities as assigned.
- Ability to travel 10%.
- Bachelor’s degree required; advanced degree (Master’s) perferred
- 5-7 years of experience direct experience in Product Quality Assurance or Manufacturing Quality within Research Use Only (RUO) and/or in-vitro diagnostic/medical device/biopharmaceutical manufacturing, with 3+ years of Management experience preferred.
- Effective data mining, trend analysis, statistical analysis, statistical process control.
- Experience with electronic product life cycle (PLM), enterprise resource planning tools (ERP), manufacturing execution systems (MES).
- Experience with enterprise Quality System tools (e.g.MasterControl, TrackWise, EDMS, CAPA/Complaint Management, Supplier Quality Management, etc.).
- Background in chemistry, biochemistry or a related engineering discipline is preferred.
- Background in oligonucleotide synthesis and surface activation chemistry a plus.
- Experience in medical device/IVD, or biotech manufacturing and a thorough knowledge and understanding of cGMP desired.
- Solid understanding of various medical device and/or IVD global regulatory requirements (e.g. CMDR, NMPA, PMDA, TGA, etc.).
- Experience with validation methodologies (IQ/OQ/PQ) in cGMP environment desired.
- Strong data analysis skills.
- SAP experience a plus.
- Salesforce experience a plus.
- Experience working and/or supporting production/laboratories desired.
- Subject matter expert using Excel and Google Sheets to generate KPIs and Data Metrics.
- Excellent verbal and written communication skills.
- Familiarity with Confluence and JIRA applications a plus.
- Strong written and verbal communication skills.
- Exposure to regulatory agency inspections (e.g., FDA, certification/notified bodies, etc.) desired.
- Proven ability to work cross-functionally to achieve business outcomes.
COVID-19 Vaccine Requirement: As of October 24,2021, all Twist Bioscience employees must be vaccinated against the COVID-19 virus. The company will follow an accommodation process for medical and religion exemptions.
About Twist Bioscience
At Twist Bioscience, we work in service of customers who are changing the world for the better. In fields such as medicine, agriculture, industrial chemicals and data storage, by using our synthetic DNA tools, our customers are developing ways to better lives and improve the sustainability of the planet.
Twist Bioscience Corporation is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.