Manager, Quality
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Job Location:
Durham, NC - USA
Monthly Salary:
Not Disclosed
Posted on:
4 days ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
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.
What You Will Do:
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.
- Up to 25% travel required
REQUIREMENTS:
How You Will Get Here
Education
Bachelors Degree or higher in Chemistry Biochemistry Engineering or other physical science degrees with relevant work experience.
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.
Knowledge Skills Abilities
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.
Excellent Benefits
- Benefits & Total Rewards Thermo Fisher Scientific
- Medical Dental & Vision benefits-effective Day 1
- Paid Time Off & Designated Paid Holidays
- Retirement Savings Plan
- Tuition Reimbursement
OTHER
- Relocation assistance is NOT provided
- 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
Required Experience:
Manager
Key Skills
- APQP
- Quality Assurance
- ISO 9001
- Lean Six Sigma
- PPAP
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Control
- Quality Management
- As9100
- Manufacturing
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
