Team Lead Regulatory Affairs managing a team of professionals at Merz Therapeutics. Ensuring compliance and optimizing regulatory processes across product lifecycles in the pharmaceutical sector.
TS
Hybrid Compliance Specialist, Audits and Inspections, Client Audits
Posted 2 hours ago
About the role
- Compliance Specialist executing quality and compliance processes at Thermo Fisher Scientific. Facilitating quality activities and mentoring staff while ensuring compliance with regulations.
Responsibilities
- Execute quality and compliance processes across the organization
- Facilitate the tracking and reporting of quality and compliance activities
- Maintain tools and materials and provide expertise to advance the vision of the department
- Investigate and resolve issues, monitor metrics, and maintain reports and documentation associated with quality and compliance activities
- Manage quality and compliance activities, ensuring they are carried out thoroughly and brought to a successful finish
- Coordinate smaller projects and process/quality improvement initiatives with proven results
- Communicate with representatives from other departments to ensure quality and timelines are maintained regarding compliance activities (e.g., client audits, CAPA, and procedural documents)
- Mentor staff and serve as a team lead for group projects or process improvement initiatives
Requirements
- Bachelor's degree in a related field or equivalent formal academic/vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
- Experience with clinical project coordination, clinical project administrator or similar experience is required
- Able to go onsite to the Austin, Texas office is required (1-3 times per month)
- Client facing experience is preferred
- Excellent oral and written communication skills
- Strong organizational and time-management skills
- Solid organizational and time-management skills
- Firm knowledge of the clinical trial process
- Thorough knowledge and understanding of ICH GCP and other relevant regulations and guidelines
- Effective problem solving skills
- Strong attention to detail
- Ability to work independently as required
- Strong computer skills; ability to learn and become proficient with appropriate software
- Ability to multitask and prioritize competing demands/work load
- Demonstrated flexibility and adaptability
Benefits
- Relocation assistance is NOT provided
- Must be legally authorized to work in the United States without sponsorship
- Must be able to pass a comprehensive background check, which includes a drug screening
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
Quality & Compliance Intern supporting service operational excellence at ATC, a specialist in data centre logistics. Enhancing service quality and operational reporting within a hybrid work environment.
Senior Manager, Regulatory Affairs Operations responsible for regulatory submissions in a biotechnology firm. Overseeing documentation, compliance, and cross - functional collaboration for FDA and EMA submissions.
Junior Consultant supporting clients in implementing security and compliance requirements through structured methods. Collaborating closely with experienced consultants in client projects.
Customs Compliance Analyst supporting Bob’s customs compliance program with analytical skills and attention to detail. Collaborating with cross - functional partners to maintain compliance documentation and streamline import processes.
Wealth and Fiduciary Compliance Manager overseeing compliance risk management at Truist Bank. Leading compliance programs and collaborating with senior management to ensure compliance with regulations.
Regulatory Affairs Manager at Duke Energy supporting South Carolina Energy Security Act implementation and managing regulatory inquiries. Ensuring compliance and fostering relationships with regulatory bodies and stakeholders.
Business Control Manager leading internal control discipline and Risk Management at Bank of America. Collaborating with teams and driving quality assurance in a technology division.
Business Control Manager at Bank of America leading risk management activities in technology division. Ensuring quality control processes within Teams and driving operational excellence.
Compliance Manager at Enterprise ensuring regulatory compliance of affordable rental properties. Collaborating with various teams to develop training and track compliance effectively.