When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
The Senior Manager of Quality is responsible for demonstrating and promoting the company vision. Providing leadership in promoting and enforcing company quality requirements, directing, writing and maintaining of required SOP’s within the company and resolving issues potentially affecting product, process, and quality/compliance.
Position can be based near one of our business sites:
Agawam, MA (Springfield, CT)
- Assists with and follows-up on non-conformances, investigations, complaints, etc. Assures that issues are resolved in a timely manner and corrective actions are implemented and monitor effectiveness to prevent recurrence.
- Evaluates and develops techniques designed to maintain awareness of SOP’s, and cGMPS’s.
- Develops and directs quality improvements.
- Extensively interacts with Distribution Center and Customer Channels Group (CCG) headquarters personnel.
- Escalates quality events (as necessary) to Sr. Global Quality Leader and works with personnel to periodically review significant aspects of operations related to quality.
- Quality sponsor and interacts with customers on quality issues and is an advocate on the company’s quality concept.
- Implements and monitors key performance indicators (KPI’s).
- Ensures the continuing review of the QA program and the creation of new or revised procedures to effect improvements.
- Provides or assists on employee training to ensure compliance with procedures and regulations.
- Supports and assists on internal, regulatory and customer audits.
- Conducts all activities in a safe and efficient manner.
- Other duties may be assigned to meet business needs.
- 4+ years experience working in an ISO (9001 or 13485 preferred) and/or FDA current Good Manufacturing Practices (cGMP) environment.
- 4+ years experience in a regulatory, quality assurance/control environment.
- Bachelors Degree or equivalent experience in a technical/scientific field, e.g. engineering, chemistry, biology, or mathematics.
- Ability to travel and work in a laboratory, warehouse or manufacturing environment.
- Experience with Quality Systems (CAPA, internal audit, complaint management, documentation management, among others), Six Sigma, Lean, or Practical Process Improvement.
- Must have understanding of validation, calibration, preventive maintenance, electronic records, among others.
- Skilled at root cause analysis and problem solving with a results orientation.
- Strong customer focused and collaboration skills.
- Excellent oral and written communication skills.
- Experienced in dealing with customers, suppliers, and senior management.
- Experienced internal and external auditor.
- Ability to travel 25-40% of the time.
- MBA / Masters Degree or equivalent experience in a technical/scientific field, e.g. engineering, chemistry, biology, or mathematics.
- Lead auditor experience.
- Skilled in WMS, Access and/or SQL database experience.
This position has not been approved for Relocation Assistance.
At Thermo Fisher Scientific, each one of our 50,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.