Associate QA Manager
Thermo Fisher Scientific•Middleton, WI
•Hybrid
About The Position
The Associate Manager Quality Assurance has responsibility for a QA team implementing elements of the quality management system. The role involves ensuring internal and/or client processes, systems and/or projects are compliant and inspection ready. The Clinical Quality Assurance Supervisor manages and develops staff and ensures delivery of quality solutions in a collaborative cross-functional environment.
Requirements
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 5 years)
- 1+ year of leadership responsibility
- Solid leadership and time management skills
- Knowledge of appropriate regional regulations and applicable global pharmaceutical industry guidelines
- For Lab QA Management, knowledge of analytical methodologies, instrumentation and method validation required
- Good verbal and written communication skills
- Demonstrated proficiency with regulations and guideline interpretation, proper documentation and QA departmental policies and procedures
- Detail oriented with ability to deal with multiple and changing priorities
- Must be legally authorized to work in the United States without sponsorship.
- Must be able to pass a comprehensive background check, which includes a drug screening.
Nice To Haves
- In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Responsibilities
- Manage the day-to-day operations of a QA team and provide oversight, development and performance management to staff to meet performance objectives
- Assess with supervisors priority of projects and monitor work assignments ensuring adequate resourcing to meet internal and client timelines and provide quality deliverables
- Assist senior management in the evaluation of QA programs to help maintain regulatory compliance and efficiency of QA audits
- Evaluate issues and trends reported by QA staff and determine appropriate departmental interpretation. Identify issues that may require follow-up or improvement. Communicate findings to staff and senior management
- Participate in client and regulatory inspections in order to provide information regarding the QA program and facilitate responses
Benefits
- Relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
