Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer.
Our Cincinnati site is a Center of Excellence for specialized oral solid dose manufacturing and drug development within our Pharma Services Group.
How you will make an impact?
The purpose of this role is to identify product and process risks; to outline improvement opportunities to mitigate identified risks; create a structure to maintain design decisions and findings for future use. This position will provide leadership and program management support for the product proactive Quality. The manager will perform duties to ensure project requirements are established and completed within a defined timeframe determined by internal customers such as Operations, PDS, and QA/QC as well as direct client communication.
What will you do
Manage the Quality Project Lead Team
Represent The Quality Function in Business Management Review Meetings
Manage the Quality on the Floor activities (support for operations and PDS)
Manage the Deviation investigation team
Supervise and manage the Complaint Program
Lead all aspects of the implementation of suitable CAPAs and CAPA effectiveness.
Drive the development of prioritized evaluation, planning and implementation approaches for products/projects that may be candidates for the proactive quality initiative.
Review and challenge where necessary the associated project plans from a technical quality and risk management point of view.
Devise landmarks for the proactive quality process; create a review process to assess the outcomes of the proactive quality analysis.
Provide recommendation action plans for improved solutions to common challenges.
Develop and coordinate scorecard/metrics for measurement of the program.
Lead communication of the program to corporate Risk Management COP team and Senior Management.
Education:
- Bachelor’s degree in a technical or related field.
- Equivalent combinations of education, training, and relevant work experience may be considered.
Experience:
- 10 + years progressive experience in the pharmaceutical industry or related industry. Demonstrates advanced knowledge in Quality Assurance.
- 5 + years experience leading mid-large organizations. Demonstrates knowledge of Good GMP. Demonstrates leadership skills. Excellent organizational skills. Excellent verbal and written communication skills. Proficient with the English language.
Competencies:
Ability to drive functional, technical and operational excellence.
Ability to inspire and foster innovation, collaboration, transparency and team effectiveness. Proven successful management of people and projects.
Good interpersonal and communication skills (both oral and written) Requires in-depth knowledge of theories and practices within at least one professional field and broad knowledge of other fields.
Previous pharmaceutical experience is strongly preferred.
What We Do
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Why Work With Us
You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.
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