Sr. Staff Quality Specialist- Psg Compliance
il y a 2 jours
When you’re part of the team at Thermo Fisher Scientific, you’ll do meaningful work, that makes a positive impact on a global scale Join 90,000 colleagues who bring our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. You’ll find the resources here to achieve your career goals and help take science a step beyond by developing solutions for some of the world’s toughest challenges. This includes protecting the environment, making sure our food is safe, helping find cures for cancer.
**Location/Division Specific Information**
**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.
**How will you make an impact?**
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.
**What will you do?**
- Provide support remotely or on-site, as requested, for specific quality/ compliance improvement needs.
- Responsible for global process and the associated policies and procedures.
- Implement and manage changes to ensure overall program goals are achieved.
- Proactively share standard methodologies and learning opportunities among sites.
- Actively participate in Industry Groups such as PDA, ISPE, PBOA, etc.
- 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.
- Other duties as assigned.
**Education**
- Bachelor’s degree or higher in Science, Engineering, or QA/ Regulatory related course of study
**Experience**
- 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
- Five or more years in a leadership position
- Experience in leading teams without direct authority
- Must be fluent in English
**Knowledge, Skills, Abilities**
- High degree of interpersonal skills to establish and maintain effective working relationships with peers and leadership, including tact to handle sensitive and confidential matters.
- Self-managed and ability to work in a fast-paced, remote environment. Effective time management and prioritization skills.
- 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.
- Flexibility with work schedules to accommodate projects based in various global timezones
- Ability to travel up to 50% of the time, domestically and internationally, up to two weeks at a time and on short notice.
At Thermo Fisher Scientific, each one of our 90,000 extraordinary minds has an outstanding story to tell. Join us in our mission to enable 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, protected veteran status, disability or any other legally protected status.
**Accessibility/Disability Access
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