„Thermo Fisher Scientific“ kuria ir tiekia technologijas, laboratorijų produktus bei farmacijos paslaugas, padedančias vykdyti mokslinius tyrimus ir teikti sveikatos priežiūrą. Įmonės veikla apima gyvybės mokslų tyrimus, analitinių problemų sprendimą, laboratorijų našumo didinimą, diagnostiką, taip pat gydymo metodų kūrimą ir gamybą. Klientams visame pasaulyje ji teikia paslaugas pasitelkdama tarptautinę komandą ir prekių ženklų portfelį, kurį sudaro „Thermo Scientific“, „Applied Biosystems“, „Invitrogen“, „Fisher Scientific“, „Unity Lab Services“, „Patheon“ ir „PPD“. Įmonės karjeros galimybės apima su šiais pasiūlymais susijusias mokslo, sveikatos priežiūros, gamybos, logistikos ir paslaugų veiklas.
Senior Clinical Quality Assurance Compliance Manager
Lead clinical quality assurance, risk management, and governance for Thermo Fisher Scientific’s clinical research business. Home-based position supporting clinical study teams across the United States.
Aprašymas
- Oversee Clinical Quality and support clinical study teams.
- Act as the client’s dedicated Quality contact.
- Work with Operations to build a consistent quality culture across clinical trial studies and portfolios.
- Attend recurring partnership meetings and other meetings as needed.
- Recommend actions to prevent issues.
- Track and periodically review QE, SSM, SB, sPIP, audit, and inspection activities.
- Escalate issues to the appropriate quality and business leaders to reduce client impact and improve outcomes.
- Enable and support Quality Risk Management.
- Prepare and review QA-related Key Quality Indicators to identify emerging trends and risks.
- Support compliance with client-specific requirements for quality events, audits, and inspection responses.
- Apply quality insights to operational lessons learned and share them across the portfolio.
- Support partnership governance.
- Co-chair Joint Quality Councils and contribute to other governance meetings.
- Present quality metrics and trends, and discuss potential resolutions with relevant stakeholders.
Reikalavimai
- Bachelor’s degree or equivalent, plus a relevant academic or vocational qualification.
- At least 8 years of compliance and quality experience, or comparable knowledge, skills, and abilities.
- Working knowledge of Good Clinical Practices (GCP).
- CRO or pharmaceutical industry experience.
- In-depth knowledge of clinical trial regulations from the FDA and EU, and ICH Guidelines.
- Strong understanding of clinical development processes under GCP and regulatory requirements.
- Demonstrated ability to build strong relationships with teams and stakeholders.
- Ability to motivate and educate clinical study teams on clinical quality.
- Ability to convey quality culture and working practices to study teams.
- Ability to communicate, receive, and understand information and ideas with diverse groups of people.
- Ability to remain upright and stationary during typical working hours.
- Proficiency with standard office equipment and technology, and ability to learn new tools.
- Ability to work under pressure while prioritizing and managing multiple projects or activities.
- Estimated travel: 0–25%.
- Must be legally authorized to work in the United States without sponsorship.
- Must pass a comprehensive background check, including drug screening.
Privalumai
- Fully remote, home-based position.
- Eligible for a variable annual bonus based on company, team, and/or individual performance.
- Relocation assistance is not available.