myGwork - LGBTQ+ Business Community · 3 days ago

Sr Quality Manager, BioProcess Equipment and Automation

Santa Clara, CA

Full-time

Onsite

Director

10+ years exp

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Responsibilities

Defines the Quality strategy for the BEA products in alignment with Division, Group and Company goals. Ensures adequate deployment and execution of such strategy.

Provides Quality leadership for a multi-site network. The BEA network is composed by our BEA Business Unit (Santa Clara, United Kingdom)

Leads matrix relationships within Thermo Fisher to ensure all product value stream touch points are aligned to deliver Quality products and processes

Drives resolution to quality issues as needed and communicates internally to senior leaders and to diverse audiences in an effective manner. Solves problems in complicated situations using analytical skills, creativity, judgment, and technical expertise. Partners with other SMEs as needed

Provides training, mentors, and coaches team members and peers

Applies Quality Risk Management to prevent risk of failure modes that impact supply of consistent supply of Quality SUD products

Conducts sophisticated data analyses to identify quality problems and to identify larger scale quality improvements.

Participates in cross functional team projects (R&D, Mfg, Vendors, etc). Examples: support new BEA product introduction projects, or quality improvement projects - identify root cause of product specific defects and apply a risk management approach to mitigate risk of Quality issues throughout the product life cycle value stream

Qualification

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Quality ManagementRegulatory ComplianceAudit ManagementQuality ToolsLean Sigma/Six SigmaProblem-SolvingCommunicationLeadershipBioprocessing TechnologyPharmaceutical ProductionMedical Device IntroductionsProject-Based Manufacturing ProcessesCapital EquipmentLean Production SystemRegulatory AffairsRAPS CertificationASQ Quality CertificationsProject Management

Required

Bachelor's degree or higher in Science, engineering or similar fields, required.

10+ years or more experience within the Pharmaceutical, Biotechnology or Medical Device Industry - supporting Regulated Products

Audit (ISO9001 or similar) or inspection (FDA or similar) management experience

Customer facing experience

Experience in Quality Management System design and oversight from a pharmaceutical perspective and/or medical device field

Strong communication skills, written and verbal. Experience leading very complex quality issues including partner concerns within the Company and with Customers. This includes direct verbal interaction, documented communications (email, letters, PowerPoint), and issuing written reports

Knowledge of Compliance with quality standards (e.g., 21 CFR Part 820, 21 CFR Part 11, ISO 13485, 9001)

Experience with the use of key quality tools e.g. FMEA, Risk Analysis, RCA and global systems e.g. TrackWise, AGILE, E1/SAP, LIMS or similar

Training/understanding in Lean Sigma/Six Sigma processes