Manager, Quality

Thermo Fisher Scientific•Durham, NC

3d•Onsite

About The Position

Join our Pharma Services team and be a part of a leading contract development and manufacturing organization (CDMO) offering end-to-end services for drug development, clinical trial logistics, and commercial manufacturing! Biotech and biopharma companies trust us for our speed, flexibility, and quality across every phase of drug development. With worldwide locations, we support active pharmaceutical ingredients (APIs), biologics, cell therapy, viral vectors, formulation, clinical trials, logistics, commercial manufacturing, and packaging. Help us enable many major therapies on the market today and drive the future of healthcare! DESCRIPTION: How will you make an impact By executing key deliverables for the implementation of a practical, proactive, sustainable, scalable, and effective Quality Risk Management Program within the Pharma Services Group. Must be highly organized with an ability to multi-task, work and communicate across multiple sites, different business units, and functions, encompassing the full product life cycle, from early product & process development through commercial manufacturing. Will assist in developing and deploying global processes and systems that must effectively work for multiple sites and will ensure and facilitate their adoption while using industry standard methodologies and body of knowledge and, incorporating different requirements and expectations from various regulatory bodies. The position will be in the Global Quality Systems – Quality Operations Team and will report to the Director of Quality Risk Management.

Requirements

Bachelor's Degree or higher in Chemistry, Biochemistry, Engineering, or other physical science degrees with relevant work experience.
Minimum of 7 years' experience in pharma/biopharma regulated industry (GxP) with strong direct hands-on pharmaceutical experience in Quality Risk Management processes, QA, Operations, Technical Services, R&D, or a combination, with a minimum of 4 years' validation experience.
Strong project management experience with ability to work in matrix / remote environment.
Proven Project Management experience.
Ability to prioritize multiple tasks across a portfolio of projects.
Ability to drive continuous improvement / operational excellence.
Ability to work independently with little supervision, especially remotely.
Proficiency in Microsoft Office Suite (Teams, Word, Excel, PowerPoint, etc.).
Ability to communicate via web-based conferencing / collaboration platforms.
Strong written and verbal communication skills and effective presentation skills.
Ability to influence peers and Quality Risk Management practitioners to overcome common pitfalls & paradigms (e.g., 'one-off' activity, an additional task, 'gray' area, not adding new value) thru the practical adoption of effective Quality Risk Management.
Must be legally authorized to work in the United States now and in the future, without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening

Responsibilities

Provide leadership and guidance for installing an effective global Quality Risk Management program.
Implement the Quality Risk Management Program Roadmap and Risk Maturity Model, and support execution of corresponding Gap Assessments.
Work with different support functions business partners to manage key elements (e.g., Leadership, Program + Tools, Training, Culture) contributing to an effective Quality Risk Management installation.
Partner and collaborate with the different Global Quality Systems groups (e.g., Supplier Quality, Digital Quality Systems, Lab Systems & Technology, Quality Operations, Global Compliance, Quality Academy, and Quality Assurance Systems) from a Quality Risk Management standpoint.
Identify, facilitate, and implement continuous improvement projects related to Quality Risk Management processes and systems thru the adoption of Practical Process Improvement (PPI) Business System.
A Quality Risk Management SME
Serve as a Lead / SME in Quality Risk Management governance processes.
Leverage Quality Risk Management practitioners across the network to support sites in the region.
Ensure risk assessments are conducted at required intervals and frequencies.
Manage the global Risk Register process / program.
Actively contribute in the Community of Practice.
Provide Quality Risk Management training
Implement 'Pilot' type of initiatives directly or indirectly related to the Quality Risk Management program.