13 ago
|
Thermo Fisher Scientific
|
México
13 ago
Thermo Fisher Scientific
México
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
Thermo Fisher Scientific Inc. is a premier company that is dedicated to enabling our customers to make the world healthier, cleaner, and safer. We are a team of 100,000+ colleagues who share a common set of values - Integrity, Intensity, Innovation, and Involvement. Together, we work to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need.
What will you do as a GCP Compliance Manager? Please read on to find out more. We would love to talk with you.
**Essential Functions**:
Provides project level QA support for multiple clients, working with internal and external teams.
Activities can include quality event review, audit and inspection support, CAPA development, and attendance at team and client meetings to provide input and consultancy.
Promotes awareness of quality and regulatory compliance standards and trends; participates in quality improvement activities.
Leads all aspects of governance and compliance management processes; implements quality awareness objectives; develops and maintains quality and compliance guidance/reference materials and tools and provides any other support or knowledge necessary to advance the vision of the Integral Quality and Compliance (GQ&C;) group.
**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’) or equivalent combination of education, training, & experience.
**GCP experience is required**
**Prior experience in a client facing role is required**
**Thorough knowledge of applicable GxP and appropriate regional regulations is required**
**Knowledge, Skills and Abilities**:
**GCP experience is required**
**Prior experience in a client facing role is required**
**Thorough knowledge of applicable GxP and appropriate regional regulations is required**
Extensive knowledge of the clinical trial process
Expert knowledge of SOPs and WPDs
Strong attention to detail
Effectively works independently or in a team environment
Highly developed problem-solving skills, risk assessment and impact analysis abilities
Strong negotiation and conflict management skills
Strong organizational and time management skills including ability to multitask and prioritize competing demands/workload
Strong computer skills; ability to learn and become proficient with appropriate software
Proven flexibility and adaptability
Travel: 0-10%
Some travel may be needed, however it should be mínimal.
**Our 4i Values**:
Integrity - Innovation - Intensity - Involvement
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.
📌 Gcp Compliance Manager - Quality Liaison (Fully Remote) (México)
🏢 Thermo Fisher Scientific
📍 México