Sr. Manager, QA Operations

at  Thermo Fisher Scientific

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.

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.

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.