SrPrincipal Safety Specialist Quality and Training Specialist QTS

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll 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 lifechanging 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.

Discover Impactful Work:

The QTS supports the management team with maintenance and review of quality documents (SOPs work instruction projectspecific data entry guidelines etc.. The QTS will also liaise with the client to review their procedural documents and ensure the PPD project team is adequately trained on clients SOPs/applicable documents.

Employee Development:

• Designing and implementing training programs to enhance employees skills and knowledge.
• Conducting onboarding sessions for newly onboarded employees to ensure they understand PPD pharmacovigilance (PV) and project specific policies and procedures.
• Identifying areas where employees may need additional training or development.
• Providing ongoing training to address skill gaps and promote continuous improvement.
• Establishing and maintaining quality standards for products services and processes (including but not limited to Quality Events (QE) and QE trending gap analysis and conducting refresher trainings).
• Monitoring and evaluating the quality performance of employees to ensure adherence to these standards.

This role will be responsible for the oversight of all quality aspects including quality assurance compliance audit and inspection support and post inspection/audit support activities

• Ensuring that training programs and quality standards comply with industry regulations and company policies/assigned projects
• Standardizing training materials and quality procedures to maintain consistency across the organization/assigned project.
• Collecting and analyzing data on training effectiveness and employee performance.
• Providing feedback to employees and management to facilitate improvement and development.

A day in the Life:

• Develop strategy and vision to set project standards for quality and training.
• Review and evaluate GPV procedures and ensure compliance.
• Develop and report PV compliance metrics related to Good Pharmacovigilance Practice (GPV) activities.
• Determine escalation procedures for issues arising from GPV and drive GPV crossfunctional process improvement activities.
• Design and deliver specialized training tailored to individual projects and focused on PV protocols project specific and PV related trainings.
• Establish and maintain effective crossfunctional team communications to advance companys quality activities and promote best practices.
• Ensure GPV readiness for PV inspections and audits.
• Collaborate with Quality department to ensure effective management.
• Actively support audits and inspections to promote a successful PV Quality Management System (QMS).
• Serve as the project point of contact for quality matters pertaining to PVrelated quality assurance activities.
• Maintain a contemporary knowledge of current clinical/ PV/technology industry trends standards and methodologies relating to PV quality management and ensures their sound application within the project.
• Develop and present summaries on quality issues and initiatives at project meetings including but not limited to internal stakeholders and client partners.
• Serve as a strategic and technical expert for production of PV quality metrics and compliance reports.
• Develop maintain and ensure the effectiveness of SOPs/protocols/work instructions/guidance documents/client directories and instructions related to GPV quality compliance and training function.
• Develop and implement measures to oversee GPV training compliance and effectiveness.
• Responsible for training and mentoring colleagues on the assigned projects.
• Actively collaborate with other functions business partners and other CROs/vendors. Ensure oversight of tasks and successful to meet client/internal project specific standards.
• Develop training plans and deliver focused training (new hires/current team member/new to project)

Keys to Success:

Education

• Bachelors/masters degree in a Pharmacy or Life sciences.

Experience

• 7 years of relevant work experience required (PV).
• 5 years of experience serving in a quality role in the pharmaceutical/biotechnology or related industry dealing with GPV activities including quality related matters and experience in supporting audits and GPV regulatory broad and deep expertise related to understanding the principles and application of quality and regulatory compliance.
• Strong knowledge of worldwide regulations pertaining to GPV for pharmaceutical products including but not limited to FDA ICH CDSCOPvPI and EU GVP; PMDA a plus.
• Strong knowledge and experience in auditing and inspections including development of responses.
• Prior experience in the management development and implementation of a riskbased global PV and QA Audit program in support of clinical safety and pharmacovigilance activities.
• Advanced knowledge of quality management systems including systematic approaches to process improvement required. Administration review and update of training management plans and implementation via the LMS
• Knowledge regarding the use of electronic systems in a regulated environment including those implemented in support of drug safety training oversight and documentation management.

Knowledge Skills Abilities

• Strong oral written communication presentation skills
• Proven ability to manage projects/teams of significant scope and complexity while meeting all deliverables and timelines.
• Demonstrated leadership and project management skills.
• Advanced ability to effectively communicate and influence the outcomes of the decisionmaking process.

Physical Requirements / Work Environment

• Work is performed in an office/remote environment with exposure to electrical office equipment
• Daily interactions with clients/associates

Benefits

We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forwardthinking 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 100000 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.

Apply today!

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.

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