Sr./Principal Safety Specialist, Quality and Training Specialist (QTS) Position Available In [Unknown county], North Carolina

Sr./Principal Safety Specialist, Quality and Training Specialist (QTS)
Location Remote, North Carolina, United States of America Job Id

R-01307996

Job Type Full time Category Clinical Research Remote Fully Remote
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.

Discover Impactful Work:

The QTS supports the management team with maintenance and review of quality documents (SOP’s, work instruction, project-specific 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’ SOP’s/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 cross-functional 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 cross-functional team communications to advance company’s 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 PV-related 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 execution 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
Bachelor’s/master’s 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 inspections.

Demonstrates 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, CDSCO-PvPI 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 risk-based 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 decision-making 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, 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.