Sr Compliance Specialist

5 months ago


Remote, United Kingdom Thermo Fisher Scientific Full time

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.

**Summarized Purpose**:
Executes document administration quality and compliance strategies and initiatives across the organization. Maintains tools and materials, serves as project lead, and provides mentoring and expertise to advance the vision of the department.

**Essential Functions**:

- Document administration oversight of documents in process from document creation, periodic review, revision, and retirement
- Researches and addresses issues, tracks metrics and maintains reports and documentation related to quality and compliance activities.
- Leads quality and compliance processes and ensures appropriate execution and completion.
- Communicates with representatives from other departments to ensure quality and timelines are maintained with respect to compliance activities around documentation procedures
- Leads smaller projects and/or some process/quality improvement initiatives.
- Mentors staff and serves as a team lead for group projects or process improvement initiatives.
- Support relocation of CDO/Clinical SOPs and other controlled documents from acquired company to client system.
- Coordinate within CDO ensuring the creation of key deliverables (SOPs and other controlled documents Integration Plan, client Clinical Gap Assessment plan,...)
- Support, coordinate and when applicable perform gap analysis of Clinical SOPs and other controlled documents. Ensure maintaining adequate records and consolidated documentation across CDO of the performed gap analysis.
- Include the identified QDs consolidation/changes needs in the Review Plan.

**_ Qualifications - External_**

**Education and Experience**:

- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
- Knowledge, Skills and Abilities:

- Strong working knowledge of document management
- Experience working with Electronic Data Management Systems (such as VEEVA, Documentum, Master Control, etc)
- Knowledge of GXP regulations (preferred)
- Excellent oral and written communication skills
- Strong organizational and time-management skills
- Demonstrated problem solving skills
- Excellent attention to detail
- Strong computer skills: ability to learn and become proficient with appropriate software
- Demonstrated ability to multitask and prioritize competing demands/workload
- Proven flexibility and adaptability.

**Our 4i Values**:
**Integrity - Innovation - Intensity - Involvement



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