Sr. Manager, QA Operations
Thermo Fisher Scientific

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.

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