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.

How will you make an impact?

This role is responsible to manage a portfolio of Clients and to update quality plans/quality performance for clients, to support product transfers from PDS and external to Commercial operations and to approve deviation/OOS/OOT investigations, validation protocols/reports, change controls, technical transfers, amongst other items. To lead/participate Failure Mode and Effect Analysis (FMEAs) and process improvements determined from trending data. The Quality Project Leader must have strong self-motivation, the ability to work independently, and within a team environment with strong follow up, organization and prioritization skills, and excellent attention to detail.

What will you do?

Essential Functions:

• Manages a portfolio of Clients and will be the key contact for Quality related topics
• Prepares quality presentations for Client meetings and present Quality approvals and timely Deviations/Out of Specifications/Out of Trends, validation protocol/reports,change controls, technical transfers
• Facilitates content of Quality Huddles, represent Quality at RAPIDs
• Leads/Participates in Risk Analysis
• Recommends Quality improvements on site based on related trends from Quality systems
• Leads Quality initiatives and provides quality assessments on process improvement activities such as Mini Transformations or Kaizens
• Works with management to resolve project issues and resource constraints within the team
• Supports decision making on projects and future directions
• Manages team member interactions
• Participation in Department Huddles as required
• Supports PAI or Client Audits as necessary
• Assists with negotiation terms of Quality agreements with the client as required
• Ensures resolution of significant quality issues with the client through coordination and collaboration of internal functional resources to identify, propose and carry out an efficient plan to settle the issue, while protecting product quality and patients safety
• Selects, develops and evaluates staff to ensure the efficient operation of the function
• Works with and advises staff on administrative policies and procedures

How will you get here?

Education:
B.Sc. in Chemistry or Biology or related field

Experience:
Minimum 10 years experience in a senior Quality Assurance or Compliance position in the pharmaceutical industry.

Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills and Abilities:

• Outstanding leadership skills; a demonstrated ability to motivate and empower.
• Ability to develop solutions that are mutually beneficial to the client and to Thermo Fisher.
• Ability to function independently and as part of a team.
• Superior communication and presentation skills, verbal and written, fluent in the English language.
• Experience writing deviations and investigations
• Ability to adapt to a changing environment quickly and easily

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 global 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

Job Category

Quality

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.