Safety Specialist / Quality and Training Specialist (QTS)

About the position

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.

Responsibilities

• Support the management team with maintenance and review of quality documents (SOP’s, work instruction, project-specific data entry guidelines etc.)
• Liaise with the client to review their procedural documents and ensure the PPD project team is adequately trained on clients’ SOP’s/applicable documents
• Design and implement training programs to enhance employees' skills and knowledge
• Conduct onboarding sessions for newly onboarded employees to ensure they understand PPD pharmacovigilance (PV) and project specific policies and procedures
• Identify areas where employees may need additional training or development
• Provide ongoing training to address skill gaps and promote continuous improvement
• Establish and maintain quality standards for products, services, and processes
• Monitor and evaluate the quality performance of employees to ensure adherence to these standards
• Oversee all quality aspects including quality assurance, compliance, audit and inspection support
• Ensure that training programs and quality standards comply with industry regulations and company policies
• Standardize training materials and quality procedures to maintain consistency across the organization
• Collect and analyze data on training effectiveness and employee performance
• Provide feedback to employees and management to facilitate improvement and development
• 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
• Establish and maintain effective cross-functional team communications to advance company's quality activities
• 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
• Develop and present summaries on quality issues and initiatives at project meetings
• 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
• 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

Requirements

• Bachelor's/master’s degree in a Pharmacy or Life sciences
• 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
• 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
• 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
• Advanced knowledge of quality management systems, including systematic approaches to process improvement required
• Knowledge regarding the use of electronic systems in a regulated environment

Nice-to-haves

• Knowledge of FDA, ICH, CDSCO-PvPI and EU GVP regulations; PMDA a plus
• Strong oral, written communication, presentation skills
• Proven ability to manage projects/teams of significant scope and complexity
• Demonstrated leadership and project management skills
• Advanced ability to effectively communicate and influence the outcomes of the decision-making process

Benefits

• Competitive remuneration
• Annual incentive plan bonus
• Healthcare
• Range of employee benefits
• Outstanding career and development prospects
• Exciting company culture that stands for integrity, intensity, involvement, and innovation