Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Discover Impactful Work:
This position has overall responsibility for the quality of products delivered to Clinical Label Services Europe customers. Manager possesses current knowledge of quality control in aGMP environment and strong leadership skills in leading quality departments to meet the demands of a thorough production schedule.
The quality systems manager uses quality knowledge to continue the development of internal quality systems. Establishes department goals and provides training for the Quality Department leadership. It is their responsibility to monitor quality day-today and report current state of quality in the organization to the GM FCS Clinical Label Services and to the Quality Director, Global Label Services located in Bohemia, NY USA.
The position requires a depth understanding of clinical trials supplies and the services that Clinical Label Services is able to provide to a client. The role requires competent use of Fisher/Clinical Label Services Systems and SOPs and will be required to perform to Fisher Clinical Services Quality Standards and timelines.
A day in the Life:
- Apply Good Manufacturing Principles in all areas of responsibility
- Investigate internal incidents and customer complaints resulting from problems originating at the site
- Analyze non-conformances/customer complaints and audit observations in the order of facilitate corrective action
- Responsible for the completion of the action items agreed to within the investigation reports
- Present metrics to Senior Management on a scheduled basis
- Lead internal auditing function of Clinical Label Services departments. Perform internal audit, prepares the report, and assigns responsibilities for corrective and preventative measures with the management team
- Heads the training program for all Quality Services department members
- Continually improve processes to operate in the high state of efficiency, quality and control
- Ensure the compliance of Clinical Label Services Europe for all qualification and validation activities
- Ensures change control is in place
- Establish personal growth goals on an annual basis including training opportunities
- Provide input to department budgets
- Work hand-in-hand with cross-functional department Managers & Supervisors to meet company goals and objectives
Keys to Success:
- College degree in technical field (or similar)
- Many years of experience in Quality leadership
Knowledge, Skills, Abilities
- Must possess knowledge of cGMP
- Must be able to write reports, business correspondence, and procedure manuals
- Must also have the ability to effectively present information and respond to questions from Senior Management, peers and clients.
- Must possess the ability to define problems, collect data, establish facts and draw valid conclusions.
- Should be self-directed and be able to work well independently and in-group.
- Position requires good organization skills as well as good written and oral communication skill.
- Superior analytical and problem solving and interpersonal skills, good computer skills and good math skill
- Requires confirmed experience with customers in a multifaceted environment
- Requires excellent communication, social skills and project co-ordination skills
What we offer:
- Employment with an innovative, future-oriented organisation
- Outstanding career and development prospects
- Company pension scheme and other fringe benefits
- Exciting company culture which stands for integrity, intensity, involvement and innovation?
If you are interested, please apply online with your CV and Motivation Letter including possible start date and salary expectations.
At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and chip in to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
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, disability or any other legally protected status.
Apply today! http://jobs.thermofisher.com