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 Area Manager, Quality Assurance will provide leadership in promoting and enforcing cGMP and company quality requirements. They will develop and or review procedures that address manufacturing, and our packaging quality system. They will act as a Quality Sponsor and notify clients of quality issues affecting their product. They will ensure that issues will be resolved in a timely manner and corrective actions are implemented and monitor the effectiveness to prevent the reoccurrence.
How will you get here?
- 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, documentation management, audits, and risk management among others).
- Must have familiarity with manufacturing and packaging quality system and a sound understanding of cGMP’s.
- Applies Good Manufacturing Principles in all areas of responsibility.
- Demonstrates and promotes company vision.
- Provides leadership in promoting and enforcing cGMP and company quality requirements.
- Instrumental in developing or reviewing procedures that address manufacturing, and packaging quality system.
- Resolves issues potentially affecting product quality/compliance.
- Assists with and follows up on deviations and, complaints etc.
- Assures that issues are resolved in a timely manner and corrective actions are implemented and monitors effectiveness to prevent reoccurrence.
- Develops and support site quality initiative improvements.
- Escalates quality events (as necessary) to QA senior management.
- Act as a Quality Sponsor and notify clients of quality issues affecting their product.
- Implements and monitors key performance indicators (KPI’s) within area of responsibility.
- Provides or assists on employee training to ensure compliance with procedures and regulations.
- Perform and direct employees job performance reviews and own full performance management cycle of 20 or more employees.
- Supports and assists on regulatory and client audits.
- Effectively interact with production floor and production management to resolve quality issues in a timely manner.
- Other duties may be assigned to meet business needs.
- Conducts all activities in a safe and efficient manner.
- Responsible for leading, training, and motivating approximately 5 direct reports.
Knowledge, Skills, Abilities:
- Capable of effectively managing up to 5 direct reports and indirect leadership of 15 or more QA Inspectors in a dynamic environment.
- Proficient communications skills when interacting with both internal and external parties.
- High ethical standards required to uphold compliance.
- 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