Senior Quality Management Specialist

Thermo Fisher Scientific • Austin, TX

4d • Onsite

About The Position

Join Us as a Senior Quality Management Specialist. This role provides regional Quality Management support and advanced subject matter expertise to Trialmed Early and Late Phase site operations and Early Development CRO Services. The role performs and leads complex quality investigations, provides expert consultation on compliance matters, supports audit and inspection readiness, and drives operational quality improvements. The role may also provide coaching, mentoring and, where assigned, supervision to more junior team members. What You'll Do: Perform and lead quality investigations of moderate to high complexity, selecting appropriate methodologies based on risk and scope and ensuring high-quality RCA and CAPA inputs. Support more complex investigations under direction of management, contributing documentation review, evidence gathering and subject matter insight. Provide regional quality consultation to operational teams on SOPs, QMS requirements, regulatory expectations, process adherence and data integrity issues. Identify quality trends and contributes proposals for corrective and preventative actions; partners with QM leadership on continuous improvement initiatives. Support audit and inspection readiness through documentation review, file checks, preparation activities and response coordination. Deliver and support training and capability-building on QMS processes, SOP requirements, systems and quality expectations. Provide mentorship, guidance and, where assigned, supervision to junior Quality Management Specialists. Represent the Quality Management function in cross-functional discussions and working groups within the assigned region. Ensure supported areas maintain operational compliance, discipline and inspection readiness.

Requirements

• 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 0 to 5 years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
• Strong understanding of GCP, regulatory requirements, enterprise QMS expectations and operational processes.
• Strong skills in quality investigations, RCA and CAPA development.
• Ability to interpret complex information and provide clear, actionable quality guidance.
• Excellent communication, consultancy and stakeholder engagement skills.
• Strong analytical and problem-solving capabilities with close attention to detail.
• Ability to organise workload, meet deadlines and adapt to changing priorities.
• Proficiency with documentation systems, quality tools and MS Office applications.
• Coaching and mentoring capability for junior staff members.

Responsibilities

• Perform and lead quality investigations of moderate to high complexity, selecting appropriate methodologies based on risk and scope and ensuring high-quality RCA and CAPA inputs.
• Support more complex investigations under direction of management, contributing documentation review, evidence gathering and subject matter insight.
• Provide regional quality consultation to operational teams on SOPs, QMS requirements, regulatory expectations, process adherence and data integrity issues.
• Identify quality trends and contributes proposals for corrective and preventative actions; partners with QM leadership on continuous improvement initiatives.
• Support audit and inspection readiness through documentation review, file checks, preparation activities and response coordination.
• Deliver and support training and capability-building on QMS processes, SOP requirements, systems and quality expectations.
• Provide mentorship, guidance and, where assigned, supervision to junior Quality Management Specialists.
• Represent the Quality Management function in cross-functional discussions and working groups within the assigned region.
• Ensure supported areas maintain operational compliance, discipline and inspection readiness.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees