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.
Fisher Clinical Services, part of Thermo Fisher Scientific, is a leading provider of global clinical supply chain. With unwavering commitment to service, science and process engineering, Fisher Clinical Services is powered by people with an exceptional commitment to quality, deeply instilled ethics of personal responsibility and unrivaled expertise. We are exclusively focused on serving the packaging and distribution requirements of clinical trials across the world. Whether planning, packaging, labeling, storing, or distributing the important supplies needed to perform clinical research, for more than 27 years Fisher Clinical Services has been committed to delivering the highest possible value while ensuring adherence to the highest level of quality, performance, reliability and sustainability standards. http://www.fisherclinicalservices.com
What will you do?
The Sr. Manager of QA will manage the change control and investigation processes. They will oversee all of compliance for validation, facility, and engineering processes. They will support and assist regulatory and client audits as well as provide quality support to assigned client accounts.
How will you get here?
- Education Bachelor’s degree (B.A. / B.S.) required.
- A minimum of 5-8 years of experience in the Pharmaceutical or related regulated industry and at least 5 years of direct supervisory experience required.
- Experience with Quality Systems (Change Control, deviations, complaint management, among others), people management.
- Understanding of validation process and facility utilities and systems.
- Applies Good Manufacturing Principles and leadership in all areas of responsibility.
- Demonstrates and promotes company vision.
- Performs all activities in a safe and efficient manner.
- Manages the investigation, and Change control processes
- Oversees the compliance of the validation , facility, and engineering processes
- Supports and assists on regulatory and client audits.
- Provides Quality support to assign client accounts.
- Implements and monitors key performance indicators (KPI’s) within area of responsibility.
- Provides supervision and training of direct reports in support of their activities.
- Other duties may be assigned to meet business needs.
- Responsible for supervising, training, and motivating approximately 6 direct reports.
Knowledge, Skills, Abilities:
- Capable of effectively managing up to 10 direct reports in a dynamic environment.
- Proficient communications skills when interacting with both internal and external parties.
- High ethical standards required to uphold compliance.
- Understanding of computer system validation
- Comfortable with decision-making on diversified issues and communicating directly with customers on a routine basis.
- Good organizational skills.
At Thermo Fisher Scientific, each one of our 65,000 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.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.