Senior Operational Quality and Compliance Specialist

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

Division Specific Information

Business Enablement - Operational Quality and Compliance brings together colleagues from across the division including: project delivery, clinical operations, pharmacovigilance, regulatory affairs, medical writing, and the clinical development academy. Our team is accountable for ensuring consistent, effective and efficient risk and issue management in addition to other quality compliance.

The position offers 100% remote working flexibility.

Discover Impactful Work:

• Proactively collaborates with initiative leads and senior management to develop, optimize and improve processes, associated systems/applications, training and communications.
• Provides guidance and support to teams in successfully identifying, analyzing, and addressing potential operational study risks.
• Strategically develops and leads large scale, complex process improvement initiatives.
• Proactively identifies and collates information required to assess compliance with processes and to prioritize business process improvement needs.
• May review, assess and update procedural documents for overall compliance with current processes.
• Performs special projects, assignments and administrative tasks per business needs.
• Mentors, coaches, and supports team members in developing and implementing process improvement initiatives.

Keys to Success:

Education

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Experience

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
• Significant clinical research experience in all phases of clinical study life cycle, including start-up, interim and close-out, is preferred.

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Strong judgment, decision making, issue resolution and risk management skills.
• Broad understanding of procedural documents
• Mature investigative and analytical skills
• Familiarity with the practices, processes, and requirements of clinical trials
• Broad understanding of clinical management technology and systems, and strong digital literacy
• Strong ability to influence
• Effective oral and written communication skills including the ability to communicate in English, both orally and in writing
• Capable of advising and promoting collaboration in a multi-disciplinary and/or multi-cultural team setting
• Broad understanding of regulatory guidelines and directives

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

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 with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.