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 our 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, required.
Experience
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
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 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
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: https://jobs.thermofisher.com/global/en/total-rewards