Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
This position is responsible for 8 sites globally, > 130 team members, and Quality teams performing critical Quality operational functions. This position works with a matrix of leaders and peers within and across divisions to provide Quality oversight, support, and consulting to our internal and external partners and customers. This is a complex role and will require travel (up to 30%) and interface with external customers and commercial teams to support divisional growth. This role will lead the GSD Quality organization from a tactical and strategic perspective and is responsible for driving the overall culture of personal quality in conjunction with the other organizational leaders. This role reports direct to the Vice President, Quality and Regulatory Affairs, Life Sciences Group with a matrixed reporting line to the President of the Genetic Sciences Division.
Responsibilities:
- Member of the GSD Leadership Team; responsible for Quality strategy and implementation across operations sites and product lifecycle management.
- Leads the global Quality functions across GSD manufacturing operations network and responsible for consistent deployment and vigilance to Quality Management System (QMS) requirements and compliance to applicable regulations and standards, including CFR 820 -QSR, ISO13485, MDSAP.
- Advises business President and GSD leadership team on product quality matters, QMS customer focus, regulatory strategies for emerging markets/new product and technology introductions
- Drives quality plans to improve product fit for purpose, customer experience, and tools/technologies supporting manufacturing advances.
- Direct Responsibilities for 8 Site Based Quality Organizations, globally.
- Indirect Product Responsibilities across 3 sites, globally.
- Contributes to the Global GSD strategy, development, and execution of Quality Management
- Creates, enhances, and sustains compliance systems for registered medical devices
- Member of the LSG Quality & Regulatory Affairs Leadership Team and functions to champion and partner global QRA strategies and initiatives.
- Supports the Commercial Business, driving revenue as a critical business partner.
- Participates in cross functional team projects (R&D, Mfg, Vendors, etc) to support New Product launches.
- Manages matrix Peer relationships to ensure compliance of the network.
- Works across multiple Divisions, product lines and types of manufacturing processes seamlessly.
- Solves problems in complicated situations using analytical skills, creativity, and judgment
- Communicates internally to senior leaders and to diverse audiences.
- Provides training, mentors, and coaches team members and peers.
- Supports complex, cross-functional quality activities in a variety of subject matter areas (e.g. biology, electrical, mechanical, chemistry and software).
- Conducts advanced data analyses to determine quality problems and to identify larger scale quality improvements.
- Addresses Emerging Regulations and compliance to written standards (e.g. ISO, QMSR), providing additional information for the site to ensure consistent application of quality processes.
- Ensures overall program and product quality improvement by guiding Peer groups in continuous process improvement implementing preventative actions and reviewing lessons learned.
Minimum Qualifications:
- Bachelor’s degree in Science or Engineering Disciplines.
- 10 years experience within the Medical Device Industry supporting Research Use only and Regulated Products.
- Expert knowledge of Quality Management Systems and oversight from a IVD/Medical Device or Pharmaceutical perspective. Regulations and quality standards ((e.g., 21 CFR Part 820, ISO 13485, 9001, MDSAP, ICH), Quality Risk Management tools e.g. FMEA, Risk Analysis, RCA, Global IT Systems e.g. TrackWise, AGILE, E1/SAP, LIMS
- Multi-site Quality Operations experience
- Demonstrated proficiency in leading quality strategy, quality planning resulting in QMS metrics improvement and sustained regulatory compliance.
- Training in Lean Sigma/Six Sigma processes.
Preferred Qualifications:
- Support of Medical Device or Pharmaceutical New Product Introductions
- Experience with establishing and maintaining a QMS supporting both RUO and Regulated products.
- Operational and strategic Leadership
- Strong proficiency in driving a culture of Quality
- Quality Engineering and Improvement
Compensation and Benefits
The salary range estimated for this position based in California is $210,200.00–$280,200.00.
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