Sr Manager, QC

at  Thermo Fisher Scientific

JOB DESCRIPTION

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

EDUCATION

• BS degree required.
• MS degree preferred in a scientific/technical field. or related field.

EXPERIENCE

• Requires 10-12 years of experience in a quality position in a regulated environment.
• Requires 5-7 years in a leadership role within the biologics and/or pharmaceutical industry.
• Significant experience in supporting functional areas (e.g. PD, Manufacturing, QA, Engineering, EHS) preferred.
• Experience with performing root cause analysis and writing Deviations and Lab Investigations required.
• Experience with regulatory inspections from the FDA, EMA, Health Canada, or other regulatory authorities.

KNOWLEDGE, SKILLS, ABILITIES

• Ability to write reports, business correspondence and procedure manuals.
• Strong interpersonal skills: ability to prioritize and lead through sophisticated processes/projects.
• Excellent interpersonal skills.
• Ability to multitask, strategically and tactically.
• Confirmed knowledge of FDA and EMA regulatory requirements applicable to biologics or pharmaceuticals.
• Ability to apply GMP regulations and international guidelines to all aspects of the position.
• Ability to read, analyze and interpret business periodicals, common scientific, professional and technical journals, financial reports, governmental regulations and legal documents.
• Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community.
• Ability to interpret and carry out an extensive variety of technical instructions in written, oral, schedule, mathematical or diagram form.
• Ability to define problems, collect data, establish facts and draw valid conclusions.
  Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
  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.

Please refer the Job description for details