Sr. Staff Quality Specialist

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.

Primary location Cambridge, MA

Will consider remote locations for:

San Francisco CA, Carlsbad CA, Princeton NJ, Durham NC, St Louis MO, Waltham MA, Swindon UK, Monza IT, Bourgoin FR and Groningen NL, Cork IRL

In the Global Compliance & External Affairs Team within Thermo Fisher Scientific’s Pharma Services Group (PSG), we define and support processes to deliver innovative and life-saving drug products from process development through commercial supply, and we offer expertise and resources to help manufacturing sites and customers expedite products to market.

As a member of the team, the Sr. Staff Quality Specialist is responsible for actively supporting the PSG Global Compliance Program and engaging with sites to ensure a continuous state of inspection readiness. Provide support remotely or on-site, as requested, for specific quality/ compliance improvement needs.

• Responsible for global process and the associated policies and procedures.
• Actively participate in Industry Groups such as PDA, ISPE, PBOA, etc.
• Other duties as assigned.
• Analyze critical metrics to identify site, division and group trends. Communicate signals and trends to Senior Quality Leadership
• External Surveillance: monitor for new and revised regulatory requirements and industry trends. Interpret regulatory and compliance requirements and work with designated process owner(s) to ensure implementation into the Global QMS and site processes.
• Proactively share standard methodologies and learning opportunities among sites.
• Implement and manage changes to ensure overall program goals are achieved.

• Bachelor’s degree or higher in Science, Engineering, or QA, or regulatory related course of study required.

• At least 7 years experience in the Pharmaceutical or Medical Device Industry with direct QA, QC or Regulatory Affairs experience, familiarity with industry trends and a proven industry network.
• Experience in leading teams without direct authority.
• Five or more years in a leadership position.

• Self-managed and ability to work in a fast-paced, remote environment. Effective time management and prioritization skills.
• Flexibility with work schedules to accommodate projects based in various global timezones
• High degree of interpersonal skills to establish and maintain effective working relationships with peers and leadership, including tact to handle sensitive and confidential matters.
• Be able to effectively communicate strategy in all levels of the organization, verbally, informally, and formally with executive team members.
• Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint. Effective presentation skills.
• Ability to travel up to 50% of the time, domestically and internationally, up to two weeks at a time and on short notice.

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!

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.

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