Sr Quality Manager, BioProcess Equipment and Automation

Overview

On Site
Full Time

Skills

Cross-functional team
Research and Development
Customer experience
Customer facing
Analytical skill
Risk management
Data Analysis
Quality improvement
Medical devices
ISO 9000
Quality management
Systems design
ISO 13485
Risk analysis
Lean Six Sigma
Six Sigma
Manufacturing
Project management
Regulatory affairs
Automation
IMPACT
Science
SAFE
Reporting
Leadership
Strategy
Software deployment
Network
Accountability
Creativity
Training
ROOT
Pharmaceutics
Biotechnology
Auditing
Inspection
FDA
Management
Communication
Regulatory Compliance
FMEA
Root cause analysis
Trackwise
Agile
SAP
LIMS
Electromechanics
Lean methodology
Scheme
Health care
Innovation

Job Details

Work Schedule

Other

Environmental Conditions

Office

Job Description

When you're part of the team at Thermo Fisher Scientific, you'll do meaningful work, that makes a positive impact on a global scale! Join 100,000 colleagues who bring our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. You'll find the resources here to achieve your career goals and help take science a step beyond by developing solutions for some of the world's toughest challenges. This includes protecting the environment, making sure our food is safe, and helping find cures for cancer.

How will you make an impact?

Reporting to the SUD Quality Director, this role will be responsible for building a customer-focused quality culture and associated quality processes. This includes a dedication to optimizing the customer experience through customer feedback and delivering products that represent industry-leading standards of product quality. Ensuring quality in our products is vital to fulling our company mission to "enable our customers to make the world a healthier, cleaner, safer place."

Location/Division Specific Information

This role resides in the Bioproduction Quality Group. Role is located at our Santa Clara, CA location.

What will you do?
  • 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
    • BEA Business Unit (Santa Clara, United Kingdom)


  • The position is expected to be customer facing, building professional relationships with their Quality counterparts within the customer organizations
  • Leads matrix relationships within Thermo Fisher to ensure all product value stream touch points are aligned to deliver Quality products and processes
  • This role is part of the BEA leadership team and therefore accountable to the business results
  • 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
How will you get here?
Education
  • Bachelor's degree or higher in Science, engineering or similar fields


Experience
  • 10+ years or more experience within the Pharmaceutical, Biotechnology or Medical Device Industry - supporting Regulated Products
  • At least 2 years of experience leading a multi-site organization
  • Audit (ISO9001 or similar) or inspection (FDA or similar) management experience
  • Customer facing experience


Knowledge, Skills, Abilities
  • 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 escalations 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


Preferred Knowledge, Skills, Abilities
  • Competency of bioprocessing technology and capabilities, pharmaceutical production, pharmaceutical new product or medical device introductions
  • Knowledge of project-based manufacturing processes including capital electromechanical equipment
  • Experience in project management
  • Understanding of Lean Production System concepts
  • Regulatory Affairs Experience and/or RAPS Certification or ASQ Quality Certifications would be a plus


We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company pension, and a range of employee benefits!

Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Compensation and Benefits

The salary range estimated for this position based in California is -.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

  • A choice of national medical and dental plans, and a national vision plan, including health incentive programs
  • Employee assistance and family support programs, including commuter benefits and tuition reimbursement
  • At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
  • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
  • Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount


For more information on our benefits, please visit: